fingolimod (Rx)

Brand and Other Names:Gilenya, Tascenso ODT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 0.25mg
  • 0.5mg

tablet, oral disintegrating

  • 0.25mg

Multiple Sclerosis

Indicated for relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

0.5 mg PO qDay

Doses >2x the recommended doses are associated with a greater incidence of adverse reactions without additional benefit

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment necessary
  • Severe: Monitor therapy; exposure the drug may double in severe hepatic impairment

Renal impairment

  • Mild-to-moderate: Not assessed
  • Severe: Blood level of some fingolimod metabolites is increased (up to 13-fold); toxicity of these metabolites has not been fully explored

Dosing Considerations

Assessment prior to initiating treatment

  • Obtain a cardiac evaluation in patients with certain preexisting conditions; determine whether patients are taking drugs that could slow heart rate or atrioventricular conduction
  • Review recent complete blood cell count (CBC) results
  • Review ALT/AST and total bilirubin levels (ie, within 6 months)
  • If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or has a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment
  • Test for antibodies to varicella zoster virus (VZV); VZV vaccination should be recommend prior to commencing treatment to antibody negative patients

Reinitiation of therapy following discontinuation

  • If discontinued for >14 days, after the first month of treatment, tapply he same first dose monitoring upon reinitiation
  • Within the first 2 weeks of treatment, first dose procedures are recommended after an interruption of 1 day or more
  • During weeks 3 and 4 of treatment, first dose procedures are recommended after an interruption >7 days

Demyelinating Polyneuropathy (Orphan)

Treatment of chronic inflammatory demyelinating polyneuropathy

Orphan indication sponsor

  • Novartis Pharmaceutical Corporation; One Health Plaza; East Hanover, NJ 07936

Dosage Forms & Strengths

capsule

  • 0.25mg
  • 0.5mg

tablet, oral disintegrating

  • 0.25mg

Multiple Sclerosis

Indicated for relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and pediatric patients aged ≥10 years

<10 years: Safety and efficacy not established

≥10 years weighing ≤40 kg: 0.25 mg PO qDay

≥10 years weighing >40 kg: 0.5 mg PO qDay

Doses >0.5 mg are associated with a greater incidence of adverse reactions without additional benefit

See also Administration

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment necessary
  • Severe: Monitor therapy; exposure the drug may double in severe hepatic impairment

Renal impairment

  • Mild-to-moderate: Not assessed
  • Severe: Blood level of some fingolimod metabolites is increased (up to 13-fold); toxicity of these metabolites has not been fully explored

Dosing Considerations

Assessment prior to initiating treatment

  • Obtain a cardiac evaluation in patients with certain preexisting conditions; determine whether patients are taking drugs that could slow heart rate or atrioventricular conduction
  • Review recent complete blood cell count (CBC) results
  • Review ALT/AST and total bilirubin levels (ie, within 6 months)
  • If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or has a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment
  • Test for antibodies to varicella zoster virus (VZV); VZV vaccination should be recommend prior to commencing treatment to antibody negative patients; if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating therapy

Reinitiation of therapy following discontinuation

  • If discontinued for >14 days, after the first month of treatment, apply the same first dose monitoring upon reinitiation
  • Within the first 2 weeks of treatment, first dose procedures are recommended after an interruption of 1 day or more
  • During weeks 3 and 4 of treatment, first dose procedures are recommended after an interruption >7 days
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Interactions

Interaction Checker

and fingolimod

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (9)

            • amiodarone

              fingolimod increases effects of amiodarone by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

            • disopyramide

              fingolimod increases effects of disopyramide by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

              fingolimod and disopyramide both increase QTc interval. Contraindicated.

            • dofetilide

              fingolimod increases effects of dofetilide by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

              fingolimod and dofetilide both increase QTc interval. Contraindicated.

            • dronedarone

              fingolimod increases effects of dronedarone by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

              fingolimod and dronedarone both increase QTc interval. Contraindicated.

            • ibutilide

              fingolimod increases effects of ibutilide by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

              fingolimod and ibutilide both increase QTc interval. Contraindicated.

            • procainamide

              fingolimod increases effects of procainamide by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

            • quinidine

              fingolimod increases effects of quinidine by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

              fingolimod and quinidine both increase QTc interval. Contraindicated.

            • sotalol

              fingolimod increases effects of sotalol by pharmacodynamic synergism. Contraindicated. Due to increased risk of bradycardia, AV block, and torsade de pointes, concomitant use is contraindicated.

              fingolimod and sotalol both increase QTc interval. Contraindicated.

            • thioridazine

              fingolimod and thioridazine both increase QTc interval. Contraindicated.

            Serious - Use Alternative (93)

            • adenovirus types 4 and 7 live, oral

              fingolimod decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

            • amiodarone

              fingolimod and amiodarone both increase QTc interval. Contraindicated.

            • amisulpride

              fingolimod and amisulpride both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.

            • anagrelide

              fingolimod and anagrelide both increase QTc interval. Avoid or Use Alternate Drug.

            • arsenic trioxide

              fingolimod and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              fingolimod and artemether both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether/lumefantrine

              fingolimod and artemether/lumefantrine both increase QTc interval. Avoid or Use Alternate Drug.

            • asenapine

              fingolimod and asenapine both increase QTc interval. Avoid or Use Alternate Drug.

            • azithromycin

              fingolimod and azithromycin both increase QTc interval. Avoid or Use Alternate Drug.

            • baricitinib

              baricitinib, fingolimod. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

            • BCG vaccine live

              fingolimod decreases effects of BCG vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • bedaquiline

              fingolimod and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine

              fingolimod and buprenorphine both increase QTc interval. Avoid or Use Alternate Drug.

            • ceritinib

              fingolimod and ceritinib both increase QTc interval. Avoid or Use Alternate Drug.

            • chloroquine

              fingolimod and chloroquine both increase QTc interval. Avoid or Use Alternate Drug.

            • chlorpromazine

              fingolimod and chlorpromazine both increase QTc interval. Avoid or Use Alternate Drug.

            • citalopram

              fingolimod and citalopram both increase QTc interval. Avoid or Use Alternate Drug.

            • clarithromycin

              fingolimod and clarithromycin both increase QTc interval. Avoid or Use Alternate Drug.

            • crizotinib

              fingolimod and crizotinib both increase QTc interval. Avoid or Use Alternate Drug.

            • droperidol

              fingolimod and droperidol both increase QTc interval. Avoid or Use Alternate Drug.

            • efavirenz

              fingolimod and efavirenz both increase QTc interval. Avoid or Use Alternate Drug.

            • eliglustat

              fingolimod and eliglustat both increase QTc interval. Avoid or Use Alternate Drug.

            • encorafenib

              fingolimod and encorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              fingolimod and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • eribulin

              fingolimod and eribulin both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin base

              fingolimod and erythromycin base both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              fingolimod and erythromycin ethylsuccinate both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              fingolimod and erythromycin lactobionate both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin stearate

              fingolimod and erythromycin stearate both increase QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and fingolimod both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

            • flecainide

              fingolimod and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • foscarnet

              fingolimod and foscarnet both increase QTc interval. Avoid or Use Alternate Drug.

            • glasdegib

              fingolimod and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • haloperidol

              fingolimod and haloperidol both increase QTc interval. Avoid or Use Alternate Drug.

            • hydroxychloroquine sulfate

              fingolimod and hydroxychloroquine sulfate both increase QTc interval. Avoid or Use Alternate Drug.

            • ifosfamide

              ifosfamide, fingolimod. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concomitant use of fingolimod and other immunosuppressants when possible. If combined, closely monitor patients for additive immunosuppressant effects (eg, infections). When switching to fingolimod after discontinuation of another immunosuppressant, consider the duration of action of the discontinued drug to avoid additive immunosuppressive effects.

            • iloperidone

              fingolimod and iloperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • influenza virus vaccine quadrivalent, adjuvanted

              fingolimod decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • influenza virus vaccine trivalent, adjuvanted

              fingolimod decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • inotuzumab

              inotuzumab and fingolimod both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • isoflurane

              fingolimod and isoflurane both increase QTc interval. Avoid or Use Alternate Drug.

            • ivosidenib

              fingolimod and ivosidenib both decrease QTc interval. Avoid or Use Alternate Drug.

            • lefamulin

              lefamulin and fingolimod both increase QTc interval. Avoid or Use Alternate Drug.

            • lofexidine

              fingolimod and lofexidine both increase QTc interval. Avoid or Use Alternate Drug.

            • lomustine

              lomustine and fingolimod both increase pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid concomitant use of fingolimod and other immunosuppressants when possible. If combined, closely monitor patients for additive immunosuppressant effects (eg, infections). When switching to fingolimod after discontinuation of another immunosuppressant, consider the duration of action of the discontinued drug to avoid additive immunosuppressive effects.

            • lopinavir

              fingolimod and lopinavir both increase QTc interval. Avoid or Use Alternate Drug.

            • macimorelin

              fingolimod and macimorelin both increase QTc interval. Avoid or Use Alternate Drug.

            • measles (rubeola) vaccine

              fingolimod decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • measles mumps and rubella vaccine, live

              fingolimod decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • measles, mumps, rubella and varicella vaccine, live

              fingolimod decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • mechlorethamine

              mechlorethamine increases effects of fingolimod by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concomitant use of fingolimod and other immunosuppressants when possible. If combined, closely monitor patients for additive immunosuppressant effects (eg, infections). When switching to fingolimod after discontinuation of another immunosuppressant, consider the duration of action of the discontinued drug to avoid additive immunosuppressive effects.

            • methadone

              fingolimod and methadone both increase QTc interval. Avoid or Use Alternate Drug.

            • midostaurin

              fingolimod and midostaurin both increase QTc interval. Avoid or Use Alternate Drug.

            • mifepristone

              fingolimod and mifepristone both increase QTc interval. Avoid or Use Alternate Drug.

            • mobocertinib

              fingolimod and mobocertinib both increase QTc interval. Avoid or Use Alternate Drug.

            • moxifloxacin

              fingolimod and moxifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • nilotinib

              fingolimod and nilotinib both increase QTc interval. Avoid or Use Alternate Drug.

            • ondansetron

              fingolimod and ondansetron both increase QTc interval. Avoid or Use Alternate Drug.

            • osimertinib

              fingolimod and osimertinib both increase QTc interval. Avoid or Use Alternate Drug.

            • oxaliplatin

              oxaliplatin increases effects of fingolimod by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of fingolimod and other immunosuppressants when possible. If combined, closely monitor for additive immunosuppressant effects (eg, infections). When switching to fingolimod after discontinuation of another immunosuppressant, consider duration of action of the discontinued drug to avoid additive immunosuppressive effects.

              fingolimod and oxaliplatin both increase QTc interval. Avoid or Use Alternate Drug.

            • paliperidone

              fingolimod and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • panobinostat

              fingolimod and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • pazopanib

              fingolimod and pazopanib both increase QTc interval. Avoid or Use Alternate Drug.

            • pentamidine

              fingolimod and pentamidine both increase QTc interval. Avoid or Use Alternate Drug.

            • pimavanserin

              fingolimod and pimavanserin both increase QTc interval. Avoid or Use Alternate Drug.

            • pimozide

              fingolimod and pimozide both increase QTc interval. Contraindicated.

            • pitolisant

              fingolimod and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • ponesimod

              ponesimod, fingolimod. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.

            • procainamide

              fingolimod and procainamide both increase QTc interval. Contraindicated.

            • procarbazine

              procarbazine increases effects of fingolimod by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of fingolimod with other immunosuppressants when possible. If combined, closely monitor for additive immunosuppressant effects (eg, infections). When switching to fingolimod after discontinuing another immunosuppressant, consider the duration of action of the discontinued drug to avoid additive immunosuppressive effects.

            • promethazine

              fingolimod and promethazine both decrease QTc interval. Avoid or Use Alternate Drug.

            • propafenone

              fingolimod and propafenone both increase QTc interval. Avoid or Use Alternate Drug.

            • quetiapine

              fingolimod and quetiapine both increase QTc interval. Avoid or Use Alternate Drug.

            • quinine

              fingolimod and quinine both increase QTc interval. Avoid or Use Alternate Drug.

            • ribociclib

              ribociclib will increase the level or effect of fingolimod by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              fingolimod and ribociclib both increase QTc interval. Avoid or Use Alternate Drug.

            • rotavirus oral vaccine, live

              fingolimod decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • saquinavir

              fingolimod and saquinavir both increase QTc interval. Avoid or Use Alternate Drug.

            • selpercatinib

              fingolimod and selpercatinib both increase QTc interval. Avoid or Use Alternate Drug.

            • sevoflurane

              fingolimod and sevoflurane both increase QTc interval. Avoid or Use Alternate Drug.

            • siponimod

              fingolimod and siponimod both increase QTc interval. Avoid or Use Alternate Drug.

            • smallpox (vaccinia) vaccine, live

              fingolimod decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • sorafenib

              fingolimod and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • tetrabenazine

              fingolimod and tetrabenazine both increase QTc interval. Avoid or Use Alternate Drug.

            • toremifene

              fingolimod and toremifene both increase QTc interval. Avoid or Use Alternate Drug.

            • trazodone

              fingolimod and trazodone both increase QTc interval. Avoid or Use Alternate Drug.

            • triptorelin

              fingolimod and triptorelin both increase QTc interval. Avoid or Use Alternate Drug.

            • typhoid vaccine live

              fingolimod decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • vandetanib

              fingolimod and vandetanib both increase QTc interval. Avoid or Use Alternate Drug.

            • varicella virus vaccine live

              fingolimod decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • vemurafenib

              fingolimod and vemurafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • yellow fever vaccine

              fingolimod decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • ziprasidone

              fingolimod and ziprasidone both increase QTc interval. Avoid or Use Alternate Drug.

            • zoster vaccine live

              fingolimod decreases effects of zoster vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            Monitor Closely (204)

            • abatacept

              abatacept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • acebutolol

              acebutolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • adalimumab

              adalimumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • albuterol

              fingolimod and albuterol both increase QTc interval. Use Caution/Monitor.

            • alefacept

              alefacept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • alemtuzumab

              alemtuzumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • alfuzosin

              fingolimod and alfuzosin both increase QTc interval. Use Caution/Monitor.

            • amitriptyline

              fingolimod and amitriptyline both increase QTc interval. Use Caution/Monitor.

            • anakinra

              anakinra increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • antithymocyte globulin equine

              antithymocyte globulin equine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • apomorphine

              fingolimod and apomorphine both increase QTc interval. Use Caution/Monitor.

            • arformoterol

              fingolimod and arformoterol both increase QTc interval. Use Caution/Monitor.

            • aripiprazole

              fingolimod and aripiprazole both increase QTc interval. Use Caution/Monitor.

            • atenolol

              fingolimod, atenolol. pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease heart rate. Monitor for bradycardia.

              atenolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • atomoxetine

              fingolimod and atomoxetine both increase QTc interval. Use Caution/Monitor.

            • azacitidine

              azacitidine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • azathioprine

              azathioprine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • basiliximab

              basiliximab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • belatacept

              belatacept and fingolimod both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • belimumab

              belimumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • bendamustine

              bendamustine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • betaxolol

              betaxolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • bisoprolol

              bisoprolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • budesonide

              budesonide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • busulfan

              busulfan increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • capecitabine

              capecitabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • carboplatin

              carboplatin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • carmustine

              carmustine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • carteolol ophthalmic

              carteolol ophthalmic increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • carvedilol

              carvedilol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • certolizumab pegol

              certolizumab pegol increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              fingolimod and certolizumab pegol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • chlorambucil

              chlorambucil increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • ciprofloxacin

              fingolimod and ciprofloxacin both increase QTc interval. Use Caution/Monitor.

            • cisplatin

              cisplatin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • cladribine

              cladribine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • clomipramine

              fingolimod and clomipramine both increase QTc interval. Use Caution/Monitor.

            • clozapine

              fingolimod and clozapine both increase QTc interval. Use Caution/Monitor.

            • cortisone

              cortisone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • cyclophosphamide

              cyclophosphamide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • cyclosporine

              cyclosporine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • cytarabine

              cytarabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • dacarbazine

              dacarbazine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • dactinomycin

              dactinomycin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • dasatinib

              fingolimod and dasatinib both increase QTc interval. Use Caution/Monitor.

            • daunorubicin

              daunorubicin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • decitabine

              decitabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • degarelix

              fingolimod and degarelix both increase QTc interval. Use Caution/Monitor.

            • denosumab

              fingolimod, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • desipramine

              fingolimod and desipramine both increase QTc interval. Use Caution/Monitor.

            • deutetrabenazine

              fingolimod and deutetrabenazine both increase QTc interval. Use Caution/Monitor.

            • dexamethasone

              dexamethasone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • diltiazem

              diltiazem increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using calcium channel blockers prior to starting fingolimod.

            • docetaxel

              docetaxel increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • dolasetron

              fingolimod and dolasetron both increase QTc interval. Use Caution/Monitor.

            • donepezil

              fingolimod and donepezil both increase QTc interval. Use Caution/Monitor.

            • doxepin

              fingolimod and doxepin both increase QTc interval. Use Caution/Monitor.

            • doxorubicin

              doxorubicin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • doxorubicin liposomal

              doxorubicin liposomal increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • epirubicin

              epirubicin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • eribulin

              eribulin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • escitalopram

              fingolimod and escitalopram both increase QTc interval. Use Caution/Monitor.

            • esmolol

              esmolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • etanercept

              etanercept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • etoposide

              etoposide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • everolimus

              everolimus increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • floxuridine

              floxuridine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • fluconazole

              fingolimod and fluconazole both increase QTc interval. Use Caution/Monitor.

            • fludarabine

              fludarabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • fludrocortisone

              fludrocortisone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • fluorouracil

              fluorouracil increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • fluoxetine

              fingolimod and fluoxetine both increase QTc interval. Use Caution/Monitor.

            • fluphenazine

              fingolimod and fluphenazine both increase QTc interval. Use Caution/Monitor.

            • fluvoxamine

              fingolimod and fluvoxamine both increase QTc interval. Use Caution/Monitor.

            • formoterol

              fingolimod and formoterol both increase QTc interval. Use Caution/Monitor.

            • fostemsavir

              fingolimod and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • gemcitabine

              gemcitabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • gemifloxacin

              fingolimod and gemifloxacin both increase QTc interval. Use Caution/Monitor.

            • gemtuzumab

              fingolimod and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • gilteritinib

              fingolimod and gilteritinib both increase QTc interval. Use Caution/Monitor.

            • glatiramer

              glatiramer increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • golimumab

              golimumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • goserelin

              goserelin increases toxicity of fingolimod by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • granisetron

              fingolimod and granisetron both increase QTc interval. Use Caution/Monitor.

            • histrelin

              histrelin increases toxicity of fingolimod by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • hydrocortisone

              hydrocortisone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • hydroxyurea

              hydroxyurea increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • hydroxyzine

              fingolimod and hydroxyzine both increase QTc interval. Use Caution/Monitor.

            • ibritumomab tiuxetan

              ibritumomab tiuxetan increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • idarubicin

              idarubicin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • imatinib

              imatinib increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • imipramine

              fingolimod and imipramine both increase QTc interval. Use Caution/Monitor.

            • indacaterol, inhaled

              fingolimod and indacaterol, inhaled both increase QTc interval. Use Caution/Monitor.

            • infliximab

              infliximab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • irinotecan

              irinotecan increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • irinotecan liposomal

              irinotecan liposomal increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • isavuconazonium sulfate

              fingolimod and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • itraconazole

              fingolimod and itraconazole both increase QTc interval. Use Caution/Monitor.

            • ixabepilone

              ixabepilone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • ketoconazole

              ketoconazole increases levels of fingolimod by Other (see comment). Use Caution/Monitor. Comment: Mechanism: affecting hepatic enzyme CYP4F2 metabolism Monitor for adverse events of fingolimod when concomitantly used with ketoconazole.

            • labetalol

              labetalol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • lapatinib

              fingolimod and lapatinib both increase QTc interval. Use Caution/Monitor.

            • leflunomide

              leflunomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • lenalidomide

              lenalidomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • lenvatinib

              fingolimod and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • leuprolide

              leuprolide increases toxicity of fingolimod by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • levalbuterol

              fingolimod and levalbuterol both increase QTc interval. Use Caution/Monitor.

            • levobunolol

              levobunolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • levofloxacin

              fingolimod and levofloxacin both increase QTc interval. Use Caution/Monitor.

            • lithium

              fingolimod and lithium both increase QTc interval. Use Caution/Monitor.

            • lomustine

              lomustine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • maprotiline

              fingolimod and maprotiline both increase QTc interval. Use Caution/Monitor.

            • mefloquine

              fingolimod and mefloquine both increase QTc interval. Use Caution/Monitor.

            • melphalan

              melphalan increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • meningococcal group B vaccine

              fingolimod decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

            • mercaptopurine

              mercaptopurine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • methotrexate

              methotrexate increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • metipranolol ophthalmic

              metipranolol ophthalmic increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • metoprolol

              metoprolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • mirtazapine

              fingolimod and mirtazapine both increase QTc interval. Use Caution/Monitor.

            • mitomycin

              mitomycin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • mitoxantrone

              mitoxantrone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • muromonab CD3

              muromonab CD3 increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • mycophenolate

              mycophenolate increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • nadolol

              nadolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • natalizumab

              natalizumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • nebivolol

              nebivolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • nelarabine

              nelarabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • nortriptyline

              fingolimod and nortriptyline both increase QTc interval. Use Caution/Monitor.

            • ocrelizumab

              fingolimod and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.

            • octreotide

              fingolimod and octreotide both increase QTc interval. Use Caution/Monitor.

            • ofatumumab

              ofatumumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • ofatumumab SC

              ofatumumab SC, fingolimod. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • ofloxacin

              fingolimod and ofloxacin both increase QTc interval. Use Caution/Monitor.

            • olanzapine

              fingolimod and olanzapine both increase QTc interval. Use Caution/Monitor. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval in rare instances

            • olaparib

              fingolimod and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

            • olodaterol inhaled

              fingolimod and olodaterol inhaled both increase QTc interval. Use Caution/Monitor.

            • osilodrostat

              osilodrostat and fingolimod both increase QTc interval. Use Caution/Monitor.

            • ozanimod

              ozanimod, fingolimod. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

            • paclitaxel

              paclitaxel increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • paclitaxel protein bound

              paclitaxel protein bound increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • pasireotide

              fingolimod and pasireotide both increase QTc interval. Use Caution/Monitor.

            • pazopanib

              pazopanib increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • pemetrexed

              pemetrexed increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • penbutolol

              penbutolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • pentostatin

              pentostatin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • perphenazine

              fingolimod and perphenazine both increase QTc interval. Use Caution/Monitor.

            • pindolol

              pindolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • ponesimod

              ponesimod and fingolimod both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • posaconazole

              fingolimod and posaconazole both increase QTc interval. Use Caution/Monitor.

            • pralatrexate

              pralatrexate increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • prednisolone

              prednisolone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • prednisone

              prednisone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • primaquine

              fingolimod and primaquine both increase QTc interval. Use Caution/Monitor.

            • prochlorperazine

              fingolimod and prochlorperazine both decrease QTc interval. Use Caution/Monitor.

            • propranolol

              propranolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • protriptyline

              fingolimod and protriptyline both increase QTc interval. Use Caution/Monitor.

            • ranolazine

              fingolimod and ranolazine both increase QTc interval. Use Caution/Monitor.

            • rilonacept

              rilonacept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • rilpivirine

              fingolimod and rilpivirine both increase QTc interval. Use Caution/Monitor.

            • risperidone

              fingolimod and risperidone both increase QTc interval. Use Caution/Monitor.

            • rituximab

              rituximab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • rituximab-hyaluronidase

              rituximab-hyaluronidase increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • romidepsin

              fingolimod and romidepsin both increase QTc interval. Use Caution/Monitor.

            • salmeterol

              fingolimod and salmeterol both increase QTc interval. Use Caution/Monitor.

            • sertraline

              fingolimod and sertraline both increase QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and fingolimod both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              fingolimod decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • sirolimus

              sirolimus increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • solifenacin

              fingolimod and solifenacin both increase QTc interval. Use Caution/Monitor.

            • sorafenib

              sorafenib increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • streptozocin

              streptozocin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • sunitinib

              sunitinib increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              fingolimod and sunitinib both increase QTc interval. Use Caution/Monitor.

            • tacrolimus

              tacrolimus increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              fingolimod and tacrolimus both increase QTc interval. Use Caution/Monitor.

            • telavancin

              fingolimod and telavancin both increase QTc interval. Use Caution/Monitor.

            • temozolomide

              temozolomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • temsirolimus

              temsirolimus increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • teniposide

              teniposide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • thalidomide

              thalidomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • thioguanine

              thioguanine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • thiotepa

              thiotepa increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • timolol

              timolol increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • timolol ophthalmic

              timolol ophthalmic increases effects of fingolimod by pharmacodynamic synergism. Use Caution/Monitor. Both medications decrease heart rate. Monitor patients on concomitant therapy, particularly in the first 6 hours after fingolimod is initiated or after a treatment interruption of at least two weeks, for bradycardia and atrioventricular block. To identify underlying risk factors of bradycardia and AV block, obtain a new or recent ECG in patients using beta-blockers prior to starting fingolimod.

            • tocilizumab

              tocilizumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • topotecan

              topotecan increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan increases levels of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • triclabendazole

              fingolimod and triclabendazole both increase QTc interval. Use Caution/Monitor.

            • trifluoperazine

              fingolimod and trifluoperazine both decrease QTc interval. Use Caution/Monitor.

            • trimipramine

              fingolimod and trimipramine both increase QTc interval. Use Caution/Monitor.

            • triptorelin

              triptorelin increases toxicity of fingolimod by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • umeclidinium bromide/vilanterol inhaled

              fingolimod and umeclidinium bromide/vilanterol inhaled both decrease QTc interval. Use Caution/Monitor.

            • ustekinumab

              ustekinumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • vardenafil

              fingolimod and vardenafil both increase QTc interval. Use Caution/Monitor.

            • venlafaxine

              fingolimod and venlafaxine both decrease QTc interval. Use Caution/Monitor.

            • vilanterol/fluticasone furoate inhaled

              fingolimod and vilanterol/fluticasone furoate inhaled both increase QTc interval. Use Caution/Monitor.

            • vinblastine

              vinblastine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • vincristine

              vincristine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • vincristine liposomal

              vincristine liposomal increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • vinorelbine

              vinorelbine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • voclosporin

              fingolimod and voclosporin both increase QTc interval. Use Caution/Monitor.

            • voriconazole

              fingolimod and voriconazole both increase QTc interval. Use Caution/Monitor.

            • vorinostat

              fingolimod and vorinostat both increase QTc interval. Use Caution/Monitor.

            • zoster vaccine recombinant

              fingolimod decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

            Minor (0)

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              Adverse Effects

              >10%

              Headache (25%)

              Liver transaminase elevations (ALT/GGT/AST) (15%)

              Nausea (13%)

              Influenza viral infection (11%)

              Sinusitis (11%)

              Abdominal pain (11%)

              Diarrhea (12%)

              Cough (12%)

              1-10%

              Back pain (10%)

              Pain in extremity (10%)

              Herpes viral infections (9%)

              Dyspnea (9%)

              Depression (8%)

              Hypertension (8%)

              Bronchitis (8%)

              Sinusitis (7%)

              Dizziness (7%)

              Lymphopenia (7%)

              Hypertension (6%)

              Migraine (6%)

              Gastroenteritis (5%)

              Weight decreased (5%)

              Paresthesia (5%)

              Tinea infections (4%)

              Bradycardia (4%)

              Blurred vision (4%)

              Eye pain (3%)

              Alopecia (3%)

              Increased blood triglycerides (3%)

              Skin papilloma (3%)

              Bradycardia (3%)

              Herpes zoster (2%)

              Tinea versicolor (2%)

              Asthenia (2%)

              Actinic keratosis (2%)

              Leukopenia (2%)

              Basal cell carcinoma (2%)

              <1%

              Seizures (0.9%)

              Macular edema (0.4%)

              Postmarketing Reports

              Hepatobiliary Disorders: Liver injury

              Blood and lymphatic system disorders: Hemolytic anemia and thrombocytopenia

              Infections: Cryptococcal infections, human papilloma virus (HPV), including papilloma, dysplasia, warts and HPV-related cancer

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              Warnings

              Contraindications

              Hypersensitivity; observed reactions include rash, urticaria, and angioedema upon treatment initiation

              History within past 6 months of MI, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure

              History or presence of Mobitz Type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker

              Baseline QTc interval ≥500 ms

              Coadministration with Class Ia or Class III antiarrhythmic drugs

              Cautions

              Bradyarrhythmia and atrioventricular blocks

              • Also see contraindications, dosing considerations, and drug interaction overview
              • Heart rate reduction
                • After the first dose, heart rate (HR) decrease starts within an hour; on Day 1, the maximum HR decline generally occurs within 6 hr and recovers, although not to baseline levels, by 8-10 hours postdose
                • Because of physiological diurnal variation, there is a second period of HR decrease within 24 hr after the first dose; in some patients, HR decrease during the second period is more pronounced than the decrease observed in the first 6 hr
                • Patients with some preexisting conditions (eg, ischemic heart disease, history of MI, CHF, history of cardiac arrest, cerebrovascular disease, uncontrolled hypertension, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, sinoatrial heart block) may poorly tolerate fingolimod-induced bradycardia, or experience serious rhythm disturbances after the first dose
                • Before initiating treatment, evaluate patients at risk by a physician appropriately trained to conduct such evaluation, and, if treated with fingolimod, monitor patient overnight with continuous ECG in a medical facility after the first dose
              • Atrioventricular blocks
                • Transient AV conduction delays observed after initiating fingolimod
                • Conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hr on treatment, but they occasionally required treatment with atropine or isoproterenol

              Infections

              • Causes dose-dependent reduction in peripheral lymphocyte count to 20-30% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues
              • May therefore increase risk of life-threatening and fatal infections (eg, disseminated varicella zoster, herpes simplex, or cryptococcal infections), including fatal meningitis, encephalitis, and multiorgan failure
              • Do not initiate with active acute or chronic infections until resolved; prior to initiation, a recent CBC (ie, within 6 months or after discontinuation of prior therapy) should be available
              • Patients without confirmed history of chickenpox or without documentation of full course of vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV before initiating therapy
              • Vaccination of antibody-negative patients is recommended prior to commencing therapy; postpone therapy 1 month to allow full effect of vaccination to occur
              • Postmarketing reports of serious infections include opportunistic pathogens including viruses John Cunningham virus (JCV), herpes simplex viruses 1 and 2, varicella-zoster virus), fungi (eg, cryptococci), and bacteria (eg, atypical mycobacteria) reported; patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and treatment
              • Cases of Kaposi’s sarcoma reported; patients with symptoms or signs consistent with Kaposi’s sarcoma should receive prompt diagnostic evaluation and management
              • Human papilloma virus (HPV) infections, including papilloma, dysplasia, warts, and HPV-related cancer, reported; vaccination against HPV should be considered prior to treatment initiation, taking into account vaccination recommendations; cancer screening, including Papanicolaou (Pap) test, is recommended as per standard of care for patients using an immunosuppressive therapy

              Progressive multifocal leukoencephalopathy

              • Progressive multifocal leukoencephalopathy (PML) reported; symptoms are diverse and included sudden onset of severe headache, altered mental status, progressive unilateral weakness, clumsiness, visual disturbances, and seizure
              • Symptoms usually reversible but may evolve into ischemic stroke or cerebral hemorrhage and delay in diagnosis and treatment may lead to permanent neurological sequelae
              • An MRI scan may find brain lesions before symptoms develop Majority of cases occurred after 2 years of treatment

              Macular edema

              • Increases risk of macular edema (with or without visual symptoms)
              • Perform an examination of the fundus including the macula in all patients before initiating treatment and 3-4 months after starting treatment or any time after a patient reports visual disturbances while in therapy
              • History of diabetes mellitus or uveitis have increased risk of macular edema

              Posterior reversible encephalopathy syndrome

              • Rare cases of posterior reversible encephalopathy syndrome (PRES) reported in adults
              • Symptoms reported included sudden onset of severe headache, altered mental status, visual disturbances, and seizure
              • Symptoms are usually reversible, but may evolve into ischemic stroke or cerebral hemorrhage
              • Transient AV conduction delays observed after initiating fingolimod
              • Conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hr on treatment, but they occasionally required treatment with atropine or isoproterenol
              • Delay in diagnosis and treatment may lead to permanent neurological sequelae; discontinue therapy if PRES suspected

              Respiratory effects

              • Dose-dependent reduction in FEV 1 and diffusion lung capacity for carbon monoxide (DLCO) observed as early as 1 month after fingolimod initiation
              • Spirometric evaluation of respiratory function and evaluation of DLCO should be performed during therapy if clinically indicated

              Liver injury

              • Liver injury with hepatocellular and/or cholestatic hepatitis reported
              • Recent (ie, within last 6 months) transaminase and bilirubin levels should be available before initiation
              • Monitor liver enzymes and bilirubin if symptoms develop suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine)
              • Monitor patients for signs and symptoms of any hepatic injury; measure liver transaminase and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice; cases of acute liver failure requiring liver transplant reported
              • Obtain transaminase levels and total bilirubin levels periodically until two months after therapy discontinuation
              • If patient is found to have alanine aminotransferase (ALT) levels greater than three times reference range with serum total bilirubin greater than two times reference range, interrupt treatment; do not resume treatment if a plausible alternative etiology for signs and symptoms cannot be established; these patients are at risk for severe drug-induced liver injury
              • Discontinue if significant liver injury is confirmed

              Fetal risk

              • Based on animal studies, may cause fetal harm
              • It takes ~2 months to eliminate fingolimod from the body; therefore, women of childbearing potential should use effective contraception to avoid pregnancy during and for 2 months after stopping treatment (see Pregnancy)

              Increased blood pressure

              • In controlled clinical trials, adults treated with fingolimod 0.5 mg had an average increase of ~3 mmHg in systolic pressure and ~2 mmHg in diastolic pressure detected after ~1 month after initiation, and persisting with continued treatment
              • Monitor blood pressure during treatment

              Cutaneous malignancies

              • Increases risk of basal cell carcinoma (BCC) and melanoma
              • Melanoma and merkel cell carcinoma reported postmarketing
              • Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer
              • Advise patients to promptly evaluate suspicious skin lesions and protect themselves from sunlight and UV light exposure

              Immune system effects

              • Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts, for up to 2 months following the last dose
              • Lymphocyte counts generally return normalizes within 1-2 months after discontinuing drug
              • Because of the continuing pharmacodynamic effects, initiating other drugs during this period warrants the same considerations needed for concomitant administration (eg, additive immunosuppressant effects) (see Drug Interaction Overview)

              Hypersensitivity reactions

              • Hypersensitivity reactions, including rash, urticaria, and angioedema have been reported
              • Contraindicated in patients with history of hypersensitivity to fingolimod or any of its excipients (see Contraindications)

              Severe increase in disability after discontinuing

              • Severe increase in disability accompanied by multiple new lesions on MRI reported after discontinuing fingolimod
              • Postmarketing reports describe patients in most of these cases did not return to the functional status they had before stopping fingolimod
              • Onset of disability generally occurred within 12 weeks after discontinuing, but was reported up to 24 weeks afterwards

              Tumefactive multiple sclerosis

              • MS relapses with tumefactive demyelinating lesions on imaging observed during therapy and after discontinuation
              • Most reported cases of tumefactive MS in patients receiving therapy have occured within first 9 months after initiation, but may occur at any point during treatment
              • Cases of tumefactive MS also reported within first 4 months after therapy discontinuation
              • Tumefactive MS should be considered when a severe MS relapse occurs during treatment, especially during initiation, or after discontinuation, prompting imaging evaluation and initiation of appropriate treatment
              • Melanoma, squamous cell carcinoma and Merkel cell carcinoma reported

              Drug interactions overview

              • Inhibitors or inducers of CYP4F2 and possibly other CYP4F isozymes might alter the exposure of fingolimod
              • Coadministration with ketoconazole (a potent inhibitor of CYP3A and CYP4F) increased fingolimod blood levels by 1.7-fold; monitor closely if coadministered
              • Antineoplastic, immunosuppressive, or immunomodulating therapies
                • Risk for additive systemic immunosuppression if coadministered with antineoplastics, immunosuppressives, or immunomodulators
                • Avoid unintended additive immunosuppression when switching from drugs with prolonged immune effects (eg, natalizumab, teriflunomide, mitoxantrone)
              • Vaccines
                • Fingolimod reduces immune response to vaccination; vaccination may be less effective during and for up to 2 months after discontinuing fingolimod
                • Avoid use of live attenuated vaccines during and for 2 months after treatment with because of the risk of infection
                • If possible, pediatric patients should be brought up to date with all immunizations in agreement with current immunization guidelines before initiating fingolimod
              • QT prolonging drugs
                • Not studied in patients treated with drugs that prolong the QT interval, which have been associated with cases of torsades de pointes in patients with bradycardia
                • Since treatment initiation of fingolimod results in decreased heart rate and may prolong the QT interval, patients on QT prolonging drugs with a known risk of torsades de pointes should be monitored overnight with continuous ECG in a medical facility
              • Drugs that slow HR or AV conduction
                • Experience with concurrent therapy with drugs that slow the heart rate or atrioventricular conduction (eg, beta blockers, digoxin, or heart rate-slowing calcium channel blockers [diltiazem, verapamil]) is limited
                • Fingolimod may result in decreased heart rate; therefore, coadministration with the aforementioned drugs during fingolimod initiation may be associated with severe bradycardia or heart block
                • Seek advice from the physician prescribing these drugs regarding the possibility to switch to drugs that do not slow HR or AV conduction before initiating fingolimod
                • Patients who cannot switch should have overnight continuous ECG monitoring after the first fingolimod dose
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              Pregnancy & Lactation

              Pregnancy

              There are no adequate data on the developmental risk associated with drug use in pregnant women

              Pregnancy exposure registry monitors pregnancy outcomes in women exposed to fingolimod during pregnancy; physicians and patients are encouraged to enroll in the pregnancy registry by calling 1-877-598-7237, sending an email to gpr@quintiles.com, or visiting www.gilenyapregnancyregistry.com

              Pregnancy status of females of reproductive potential should be verified prior to starting treatment

              Advise pregnant women of the potential risk to a fetus

              Animal data

              • In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryo lethality, when given to pregnant animals
              • In rats, highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m²) basis; most common fetal visceral malformations in rats were persistent truncus arteriosus and ventricular septal defect; receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis

              Contraception

              • Before treatment initiation, counsel women of childbearing potential regarding potential for serious fetal risk and the need for effective contraception during treatment
              • Since it takes ~2 months to eliminate the compound from the body after discontinuing treatment, potential risk to the fetus may persist and women should use effective contraception during this period; females planning to become pregnant, therapy should be stopped 2 months before conception

              Lactation

              There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production

              Fingolimod is excreted in the milk of treated rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk

              Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for fingolimod and any potential adverse effects on the breastfed infant from fingolimod or from the underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Sphingosine 1-phosphate receptor modulator; metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate.

              Binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5; blocks lymphocyte capacity to egress from lymph nodes, and thereby reduces the lymphocyte count in peripheral blood

              The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system

              Absorption

              Bioavailability: 93%

              Plasma Time: 12-16 hr

              Steady-State: Time to steady state is 1-2 months following daily dosing; steady-state levels approximately 10-fold greater than initial dose

              Distribution

              86% distributed in RBCs

              Protein Bound: >99%

              Vd: 1200 L

              Metabolism

              Primarily by CYP4F2, minor substrate of CYP2D6, 2E1, 3A4, and 4F12

              Elimination

              Half-life: 6-9 days

              Clearance: 6.3 L/hr

              Excretion: Feces (<2.5%), urine (81% as inactive metabolites)

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              Administration

              Oral Administration

              May take with or without food

              Also see Dosing Considerations

              First dose monitoring

              • Administer in a setting which has the ability to manage symptomatic bradycardia; observe heart rate (HR) and blood pressure hourly for at least 6 hr post dose; obtain ECG prior to first dose and at the end of observation period
              • Additional monitoring after 6 hr
                • Heart rate 6 hours postdose is <45 bpm
                • Heart rate 6 hours postdose at the lowest post-dose value (suggesting maximal effect on heart rate may not yet have occurred), or if new onset second-degree or higher AV block occurs
              • Overnight monitoring
                • Institute continuous overnight ECG monitoring in a medical facility:
                • Patients that require pharmacologic intervention for symptomatic bradycardia; these patients, first dose monitoring strategy should be repeated after second dose of fingolimod
                • Patients with some preexisting heart and cerebrovascular conditions
                • Patients with a prolonged QTc interval before dosing or during 6 hr observation, or at additional risk for QT prolongation, or on concurrent therapy with QT prolonging drugs
                • Patients receiving concurrent therapy with drugs that slow heart rate or atrioventricular conduction

              Storage

              Capsules: Store at 25°C (77°F); excursions permitted to 15-30°C (59–86°F); protect from moisture

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Gilenya oral
              -
              0.5 mg capsule

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              fingolimod oral

              FINGOLIMOD - ORAL

              (fin-GOL-i-mod)

              COMMON BRAND NAME(S): Gilenya

              USES: This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking fingolimod and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Before starting fingolimod, your doctor will do medical/laboratory tests (such as complete blood count, blood pressure, EKG, pulse, eye exam) to monitor for side effects. Take this medication by mouth with or without food as directed by your doctor, usually once a day. You will be monitored for at least 6 hours after the first dose to make sure your heartbeat does not go too slow. A very slow heartbeat increases the risk for a serious heart rhythm problem (QT prolongation in the EKG). Tell your doctor if you have low levels of magnesium/potassium in the blood, personal or family history of QT prolongation in the EKG, family history of sudden cardiac death, or heart failure. Also tell your doctor if you are taking other drugs that can slow down your heartbeat or affect heart rhythm (such as causing QT prolongation in the EKG). See also Drug Interactions section.A small number of people using this drug have had MS symptoms become much worse - or become permanently disabled - after stopping fingolimod. Do not stop using fingolimod without talking to your doctor first. If your doctor temporarily stops your fingolimod, you may need to be heartbeat-monitored again for at least 6 hours after you restart this medication. Children who have their dosage increased may also need to be monitored again for 6 hours. Ask your doctor for details.The dosage is based on your age and weight. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: Cough, headache, back pain, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Fingolimod may increase the risk of skin cancer and lymphoma. Tell your doctor right away if you notice any new or changing skin growths/moles, or swollen lymph nodes.This medication can weaken your immune system/increase the risk of infection while you are taking it and for 2 months after your last dose. You may be more likely to get a serious (possibly fatal) infection (such as bronchitis, pneumonia, herpes). Tell your doctor right away if you develop any signs of an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, cold/flu symptoms, sores, or blisters. Do not start fingolimod if you already have an infection.Fingolimod may increase the risk of a rare (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). This may sometimes occur even after treatment has stopped. Symptoms of PML can seem like a worsening MS attack. Tell your doctor right away if you have any new or worsening symptoms that have lasted for several days, such as clumsiness or problems with strength, balance, speech, eyesight, or thinking.Get medical help right away if you have any very serious side effects, including: shortness of breath, chest pain, severe dizziness/fainting, slow/irregular/pounding/fast heartbeat, unusual tiredness/weakness, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes), mental changes (such as sudden confusion), seizure, sudden/severe headache.This medication may rarely cause serious liver problems. Tell your doctor right away if you experience: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also How to Use section.Before taking fingolimod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, bronchitis, emphysema, sleep apnea), current/recent/returning infection (including hepatitis and tuberculosis), diabetes, fainting, certain eye problems (macular edema, uveitis), heart problems (such as slow/irregular heartbeat, heart failure, previous heart attack, chest pain, QT prolongation in the EKG), high blood pressure, liver disease, stroke or "mini-stroke"/transient ischemic attack (TIA).Fingolimod can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using fingolimod before having any immunizations/vaccinations. Avoid getting a live vaccine for 2 months after the last dose of this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).This medication may increase your risk of developing skin cancer. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Your doctor may direct you to avoid phototherapy while you use this product. Ask your doctor for details.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking fingolimod. Fingolimod may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while taking this medication and for 2 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some of the products that may interact with this drug include: ketoconazole, drugs that slow down your heartbeat (including digoxin, beta-blockers such as atenolol/metoprolol, calcium channel blockers such as diltiazem/verapamil), certain drugs for irregular heartbeat (including amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, sotalol), other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, blood pressure, pulse, EKG, MRI, eye exams, liver function tests, lung/breathing tests, exams to check for skin cancer, Pap smear) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised December 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
              Additional Offers
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.