romidepsin (Rx)

Brand and Other Names:Istodax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 5mg/mL( 2-mL, 5.5-mL single-dose vials)
  • Includes diluent for reconstitution

Cutaneous T-Cell Lymphoma

Indicated for CTCL in patients who have received at least 1 prior systemic therapy

14 mg/m2 IV on days 1, 8, and 15 of 28-d cycle  

Continue until disease progression or intolerable toxicity

Peripheral T-Cell Lymphoma

Indication was voluntarily withdrawn in the U.S. by manufacturer in August 2021 based on failure to meet the primary efficacy endpoint of progression free survival in a phase 3 trial evaluating romidepsin plus CHOP versus CHOP for first-line peripheral T-cell lymphoma patients

Dosage Modifications

Nonhematologic toxicities (except alopecia)

  • Grade 2 or 3 toxicity: Hold dose until toxicity declines to Grade 1 or baseline, then restart at 14 mg/m2
  • If Grade 3 toxicity recurs, hold dose until toxicity returns to Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2
  • Grade 4 toxicity: Hold dose until toxicity declines to Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2
  • Discontinued if Grade 3 or 4 toxicities recur after dose reduction

Hematologic toxicities

  • Grade 3 or 4 neutropenia or thrombocytopenia: Hold dose until toxicity improves to ANC >1.5×109/L and/or platelet count >75×109/L or baseline, then restart at 14 mg/m2
  • Grade 4 febrile (>38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion: Delay dose until the specific cytopenia returns to Grade 1 or baseline, and then permanently reduce dose to 10 mg/m2

Renal impairment

  • No dose adjustment required
  • Pharmacokinetics of romidepsin not influenced by renal impairment

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate (bilirubin levels >1.5x to ≤3x ULN): Reduce starting dose to 7 mg/m2
  • Severe (bilirubin levels >3x ULN): Reduce starting dose to 5 mg/m2

Safety and efficacy not established

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Interactions

Interaction Checker

and romidepsin

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            Contraindicated (1)

            • lefamulin

              lefamulin will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.

            Serious - Use Alternative (86)

            • abametapir

              abametapir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • amiodarone

              amiodarone and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • amobarbital

              amobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • apalutamide

              apalutamide will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • arsenic trioxide

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

            • artemether

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

            • artemether/lumefantrine

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

            • atazanavir

              atazanavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • bosentan

              bosentan will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • butabarbital

              butabarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • carbamazepine

              carbamazepine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • ceritinib

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

            • cimetidine

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

            • clarithromycin

              clarithromycin will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • clozapine

              clozapine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • dabrafenib

              dabrafenib will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • darunavir

              darunavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • dexamethasone

              dexamethasone will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • disopyramide

              disopyramide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • dofetilide

              dofetilide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • dolasetron

              dolasetron and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • droperidol

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

            • entrectinib

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

            • enzalutamide

              enzalutamide will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erdafitinib

              erdafitinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

            • erythromycin base

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

            • erythromycin ethylsuccinate

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

            • erythromycin lactobionate

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

            • erythromycin stearate

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

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • etravirine

              etravirine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • fexinidazole

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

              fexinidazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • flecainide

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

            • fosamprenavir

              fosamprenavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • glasdegib

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

            • haloperidol

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

            • hydroxychloroquine sulfate

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

            • ibutilide

              ibutilide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • iloperidone

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

            • indinavir

              indinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • inotuzumab

              inotuzumab and romidepsin 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.

            • ivosidenib

              ivosidenib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

              ivosidenib will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              ketoconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • lonafarnib

              lonafarnib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • lopinavir

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

            • lumefantrine

              lumefantrine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • methadone

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

            • mifepristone

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

            • mobocertinib

              mobocertinib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • nafcillin

              nafcillin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • nefazodone

              nefazodone will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • nelfinavir

              nelfinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • nevirapine

              nevirapine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • ondansetron

              ondansetron and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • palifermin

              palifermin increases toxicity of romidepsin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis..

            • paliperidone

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

            • panobinostat

              romidepsin 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.

            • pentamidine

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

            • pentobarbital

              pentobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • phenobarbital

              phenobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • phenytoin

              phenytoin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of romidepsin and phenytoin, a potent CYP3A4 inducer, as this may decrease romidepsin concentrations and efficacy.

            • pimozide

              pimozide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • pitolisant

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

            • primidone

              primidone will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • procainamide

              procainamide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • quinidine

              quinidine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              quinidine and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • ribociclib

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

              ribociclib increases toxicity of romidepsin by QTc interval. Avoid or Use Alternate Drug.

            • rifabutin

              rifabutin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • rifampin

              rifampin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • rifapentine

              rifapentine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • ritonavir

              ritonavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

            • saquinavir

              saquinavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors shoul d be avoided if possible.

            • secobarbital

              secobarbital will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • sotorasib

              sotorasib will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • St John's Wort

              St John's Wort will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inducers should be avoided if possible.

            • tucatinib

              tucatinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • umeclidinium bromide/vilanterol inhaled

              romidepsin increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vandetanib

              romidepsin, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.

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

            • vemurafenib

              vemurafenib and romidepsin both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended. Romidepsin may also increase vemurafenib levels.

            • vilanterol/fluticasone furoate inhaled

              romidepsin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • voriconazole

              voriconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong 3A4 inhibitors should be avoided if possible.

              romidepsin and voriconazole both increase QTc interval. Avoid or Use Alternate Drug. Concurrent administration of romidepsin with voriconazole may cause an increase in systemic romidepsin concentrations and prolong QTc interval.

            • voxelotor

              voxelotor will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (133)

            • albuterol

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

            • alfuzosin

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

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

            • amiodarone

              amiodarone will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • amitriptyline

              amitriptyline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • amoxapine

              amoxapine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • apomorphine

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

            • aprepitant

              aprepitant will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • arformoterol

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

            • aripiprazole

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

            • artemether/lumefantrine

              artemether/lumefantrine will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • atomoxetine

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

            • azithromycin

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

              azithromycin will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • bedaquiline

              romidepsin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • berotralstat

              berotralstat will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • carbamazepine

              carbamazepine will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • cenobamate

              cenobamate will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • chloramphenicol

              chloramphenicol will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • chloroquine

              chloroquine increases toxicity of romidepsin by QTc interval. Use Caution/Monitor.

            • chlorpromazine

              chlorpromazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • cholera vaccine

              romidepsin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • citalopram

              romidepsin and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • clarithromycin

              clarithromycin will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              clarithromycin and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • clomipramine

              clomipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • cobicistat

              cobicistat will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • conivaptan

              conivaptan will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              crizotinib increases levels of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

              crizotinib increases levels of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

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

            • cyclosporine

              cyclosporine will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              cyclosporine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • dasatinib

              dasatinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

            • deferasirox

              deferasirox will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • degarelix

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

            • dengue vaccine

              romidepsin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • desipramine

              desipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • dichlorphenamide

              dichlorphenamide and romidepsin both decrease serum potassium. Use Caution/Monitor.

            • doxepin

              doxepin and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • dronedarone

              dronedarone will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              dronedarone will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              dronedarone and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • efavirenz

              efavirenz will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration with strong 3A4 inducers should be avoided if possible.

            • elagolix

              elagolix decreases levels of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • encorafenib

              encorafenib, romidepsin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • epinephrine racemic

              epinephrine racemic and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin base

              erythromycin base will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin base and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin ethylsuccinate and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin lactobionate and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              erythromycin stearate and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • escitalopram

              escitalopram increases toxicity of romidepsin by QTc interval. Use Caution/Monitor.

            • ethinylestradiol

              romidepsin decreases effects of ethinylestradiol by receptor binding competition. Use Caution/Monitor.

            • ezogabine

              ezogabine, romidepsin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.

            • fedratinib

              fedratinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • fluconazole

              fluconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              fluconazole and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluoxetine

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

            • fluphenazine

              fluphenazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluvoxamine

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

            • foscarnet

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

            • fostemsavir

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

            • gemtuzumab

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

            • goserelin

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

            • grapefruit

              grapefruit will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • griseofulvin

              griseofulvin will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • histrelin

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

            • imipramine

              imipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • indacaterol, inhaled

              indacaterol, inhaled, romidepsin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • indapamide

              indapamide and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • isoniazid

              isoniazid will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • itraconazole

              itraconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor for toxicity related to increased romidepsin exposure and follow the dose modifications for toxicity when romidepsin is initially coadministered with strong CYP3A4 inhibitor.

              itraconazole and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • ketoconazole

              ketoconazole will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              ketoconazole and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • lapatinib

              lapatinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              lapatinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

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

            • lenvatinib

              romidepsin 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 romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • levofloxacin

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

            • lomitapide

              lomitapide increases levels of romidepsin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

            • lonafarnib

              lonafarnib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • lorlatinib

              lorlatinib will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • maprotiline

              maprotiline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • mestranol

              romidepsin decreases effects of mestranol by receptor binding competition. Use Caution/Monitor.

            • miconazole vaginal

              miconazole vaginal will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • mifepristone

              mifepristone, romidepsin. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

            • mitotane

              mitotane decreases levels of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • modafinil

              modafinil will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • moxifloxacin

              moxifloxacin and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • nefazodone

              nefazodone will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nicardipine

              nicardipine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              nilotinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              nilotinib and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • nortriptyline

              nortriptyline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • octreotide

              octreotide and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • octreotide (Antidote)

              octreotide (Antidote) and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • ofatumumab SC

              ofatumumab SC, romidepsin. 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

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

            • olodaterol inhaled

              romidepsin and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

            • osilodrostat

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

            • oxaliplatin

              oxaliplatin will increase the level or effect of romidepsin by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • ozanimod

              ozanimod and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • pasireotide

              romidepsin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pazopanib

              pazopanib and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • perphenazine

              perphenazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • posaconazole

              posaconazole will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

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

            • protriptyline

              protriptyline and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • quetiapine

              quetiapine, romidepsin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

            • quinine

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

            • ranolazine

              ranolazine will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              ranolazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • rifampin

              rifampin will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rilpivirine

              rilpivirine increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.

            • risperidone

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

            • ritonavir

              ritonavir will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • selpercatinib

              selpercatinib increases toxicity of romidepsin by QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and romidepsin 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.

            • sorafenib

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

            • sotalol

              romidepsin and sotalol both increase QTc interval. Modify Therapy/Monitor Closely.

            • St John's Wort

              St John's Wort will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • stiripentol

              stiripentol, romidepsin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tacrolimus

              tacrolimus will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • tazemetostat

              tazemetostat will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • telavancin

              romidepsin and telavancin both increase QTc interval. Modify Therapy/Monitor Closely.

            • thioridazine

              thioridazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • tipranavir

              tipranavir will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              tipranavir will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • topiramate

              topiramate will decrease the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • trastuzumab

              trastuzumab, romidepsin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, romidepsin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • trazodone

              trazodone will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • triclabendazole

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

            • trifluoperazine

              trifluoperazine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • trimipramine

              trimipramine and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • triptorelin

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

            • tucatinib

              tucatinib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • vandetanib

              vandetanib will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • venlafaxine

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

            • verapamil

              verapamil will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              verapamil will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • vinblastine

              vinblastine will decrease the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • voclosporin

              voclosporin, romidepsin. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • warfarin

              romidepsin increases effects of warfarin by unknown mechanism. Use Caution/Monitor. Possible elevation of INR.

            • zafirlukast

              zafirlukast will increase the level or effect of romidepsin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ziprasidone

              romidepsin and ziprasidone both increase QTc interval. Modify Therapy/Monitor Closely. Avoid using ziprasidone with other QTc prolonging agents.

            Minor (0)

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              Adverse Effects

              >10%

              Asthenia/fatigue (53-77%)

              Anorexia (23-54%)

              Constipation (12-40%)

              Diarrhea (20-36%)

              Nausea (56-86%)

              Vomiting (34-52%)

              Anemia (19-72%)

              Hypomagnesemia (22-28%)

              Neutropenia (11-66%)

              Thrombocytopenia (17-72%)

              Infections (46-54%)

              <10%

              Hypotension

              EKG changes

              Exfoliative dermatitis

              Pruritus

              Hypocalcemia

              Hypokalemia

              Leukopenia

              Lymphopenia

              Hypoalbuminemia

              Hyperglycemia

              Hyponatremia

              Increased LFTs

              Postmarketing Reports

              Pyrexia, dysgeusia, headache cough, dyspnea, abdominal pain stomatitis

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              Warnings

              Contraindications

              Hypersensitivity

              Cautions

              QT prolongation; potassium and magnesium should be within normal limits before administration

              Tumor lysis syndrome has been reported; patients with advanced stage disease and/or high tumor burden should be closely monitored and appropriate precautions taken

              Monitor hematologic parameters; interrupt/discontinue treatment if thrombocytopenia, leukopenia, or anemia becomes severe

              Serious and sometimes fatal infections reported with 30 days after treatment including pneumonia, sepsis, and viral reactivation (eg, Epstein Barr, hepatitis B viruses); risk may be greater in patients with a history of monoclonal antibodies treatment directed against lymphocyte antigens and in patients with disease involvement of the bone marrow

              Avoid during pregnancy, no adequate trials exist; based on MOA, likely to cause fetal harm

              Drug interaction overview

              • Coadministration with other drugs that prolong QT interval (eg, sotalol, dofetilide, erythromycin) may increase risk for serious arrhythmias
              • Binds to estrogen and may reduce effectiveness of oral contraceptives
              • May increase effect of warfarin (prolonged PT, increased INR)
              • Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase romidepsin serum levels
              • Potent CYP3A4 inducers (eg, dexamethasone, carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) may decrease romidepsin serum levels
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              Pregnancy & Lactation

              Pregnancy

              Based on its mechanism of action and findings from animal studies, may cause embryo-fetal harm when administered to a pregnant woman

              There are no available data on use in pregnant women to inform a drug associated risk of major birth defects and miscarriage

              Advise women of the potential risk to fetus and to avoid becoming pregnant during treatment and for at least 1 month after last dose

              Animal data

              • In an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryofetal toxicity and malformations at exposures below those in patients at the recommended dose

              Pregnancy testing

              • Perform pregnancy testing in females of reproductive potential within 7 days before initiating

              Contraception

              • Females of reproductive potential: Use effective contraception during treatment and for at least 1 month after last dose
              • May reduce the effectiveness of estrogen-containing contraceptives; use alternative methods of non-estrogen containing contraception (eg, condoms, intrauterine devices)
              • Males with female partners of reproductive potential: Use effective contraception to avoid fathering a child during treatment and for at least 1 month after last dose

              Infertility

              • Based on findings in animals, romidepsin has the potential to affect male and female fertility

              Lactation

              • There are no data on presence of drug or its metabolites in human milk, effects on breastfed children, or effects on milk production
              • Advise lactating women not to breastfeed during treatment and for at least 1 week after last dose

              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

              Histone deacetylase (HDAC) inhibitor; induces arrest in the cell cycle at G1 and G2/M phases, which in turn causes cell death

              Absorption

              Peak plasma concentration: 377 ng/mL

              AUC: 1549 ng⋅hr/mL

              Distribution

              Protein bound: 92-94%

              Found to be a BSEP and OATP1 inhibitor

              Metabolism

              Extensive metabolism by CYP3A4 with minor contribution from CYP3A5, CYP1A1, CYP2B6, and CYP2C19

              Elimination

              Half-life: ~3 hr

              No accumulation of plasma concentration of romidepsin was observed after repeated dosing

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              Administration

              IV Compatibility

              0.9% NaCl

              IV Preparation

              Handle according to recommended safe handling procedures for cytotoxic drugs

              Reconstitute single-dose vials with supplied diluent (10-mg vial with 2.2 mL ; 27.5-mg vial with 5.5 mL)

              Swirl vial contents until there are no visible particles in the resulting solution; reconstituted solution will contain 5 mg/mL

              Withdraw and inject desired amount from vials into 500 mL 0.9% NaCl

              IV Administration

              Administer & dispose according to recommended safe handling procedures for cytotoxic drugs

              Infuse IV over 4 hr

              Administer IV infusion via volumetric infusion pump

              Diluted solution compatible w/ PVC, EVA, PE infusion bags, or glass bottles

              Storage

              Store according to recommended safe handling procedures for cytotoxic drugs

              Unopened vials: Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF) in the carton; protect from light

              Reconstituted vials: Stable for at least 8 hr at room temperature

              Diluted solutions: Store at room temperature for up to 24 hr

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              romidepsin intravenous
              -
              10 mg/2 mL vial
              romidepsin intravenous
              -
              10 mg/2 mL vial
              romidepsin intravenous
              -
              5 mg/mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              romidepsin intravenous

              ROMIDEPSIN - INJECTION

              (ROE-mi-DEP-sin)

              COMMON BRAND NAME(S): Istodax

              USES: Romidepsin is used to treat certain types of cancer (cutaneous T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before your first romidepsin treatment and each time you get another dose. If you have any questions regarding the information, ask your doctor or pharmacist.This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually over 4 hours on days 1, 8, and 15 of a 28-day treatment cycle. This cycle is then repeated as directed by your doctor.The dosage is based on your medical condition, body size, and response to treatment.You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

              SIDE EFFECTS: Nausea, vomiting, tiredness, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. It may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills, cough), easy bruising/bleeding.Get medical help right away if you have any very serious side effects, including: chest pain, fast/irregular heartbeat, severe dizziness, fainting.Romidepsin sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.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: Before receiving this medication, 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: liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), current/recent infection.Romidepsin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using romidepsin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using romidepsin safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Romidepsin 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.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using romidepsin. Romidepsin may harm an unborn baby. Your doctor may order a pregnancy test before starting treatment with this medication. Women and men using this medication should ask about reliable forms of birth control during treatment and for 1 month after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Drug Interactions section.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for 1 week after stopping this medication. 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 products that may interact with this drug include: disulfiram, "blood thinners" (such as warfarin).Other medications can affect the removal of romidepsin from your body, thereby affecting how romidepsin works. These drugs include azole antifungals (such as itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (such as clarithromycin), HIV drugs (such as ritonavir), nefazodone, rifamycins (such as rifabutin, rifampin), St. John's wort, and some drugs used to treat seizures (such as carbamazepine), among others.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication and for 1 month after stopping treatment. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

              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: Lab and/or medical tests (such as complete blood count, potassium/magnesium blood levels, EKG, liver function) should be done while you are using this medication. Keep all medical and lab appointments.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 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.
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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.