vortioxetine (Rx)

Brand and Other Names:Trintellix
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, immediate-release

  • 5mg
  • 10mg
  • 20mg
  • NOTE: Former brand name Brintellix

Major Depressive Disorder

Indicated for major depressive disorder (MDD) in adults

10 mg PO qDay; dose should then be increased to 20 mg/day, as tolerated

Consider decreasing dose to 5 mg/day if higher doses are not tolerated

Efficacy and safety of doses >20 mg/day have not been evaluated

Dosage Modifications

CYP2D6 poor metabolizers: Not to exceed 10 mg/day

CYP2D6 inhibitors

  • Reduce vortioxetine by one-half when coadministered with CYP2D6 inhibitors (eg, bupropion, fluoxetine, paroxetine, quinidine)
  • Increase dose to original dose when CYP2D6 inhibitor is discontinued

CYP inducers

  • Consider increasing vortioxetine dose when coadministered with strong CYP inducer (eg, rifampin, carbamazepine, phenytoin) for >14 days; not to exceed 3x the original dose
  • Reduce to original dose within 14 days, when inducer is discontinued

Renal or hepatic impairment

  • No dosage adjustment necessary

Dosing Considerations

Before initiating treatment

  • Screen for personal or family history of bipolar disorder, mania, or hypomania

Discontinuing treatment

  • May be abruptly discontinued; patients may experience transient adverse reactions (eg, headache, muscle tension) following abrupt discontinuation if dose is 15-20 mg/day
  • To avoid these adverse reactions, decrease to 10 mg/day for 1 week before full discontinuation of 15-20 mg/day doses

Switching to or from a monoamine oxidase inhibitor (MAOI)

  • Discontinuation of MAOI and starting vortioxetine: Wait at least 14 days after discontinuation
  • Discontinuation of vortioxetine and starting MAOI: Wait at least 21 days after discontinuation

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and vortioxetine

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            Contraindicated (8)

            • isocarboxazid

              isocarboxazid, vortioxetine. Either increases effects of the other by serotonin levels. Contraindicated.

            • linezolid

              linezolid increases toxicity of vortioxetine by serum potassium. Contraindicated. Linezolid may increase serotonin as a result of MAO-A inhibition. If linezolid must be urgently administered, discontinue vortioxetine immediately and monitor for serotonin syndrome. Monitor for serotonin syndrome for 3 weeks or 24 hr after last linezolid dose, whichever comes first. Vortioxetine may be resumed 24 hr after last linezolid dose.

            • methylene blue

              methylene blue increases toxicity of vortioxetine by serotonin levels. Contraindicated. Methylene blue may increase serotonin as a result of MAO-A inhibition. If methylene blue must be urgently administered, discontinue vortioxetine immediately and monitor for serotonin syndrome. Monitor for serotonin syndrome for 3 weeks or 24 hr after last methylene blue dose, whichever comes first. Vortioxetine may be resumed 24 hr after last methylene blue dose.

            • phenelzine

              phenelzine increases toxicity of vortioxetine by serotonin levels. Contraindicated.

            • rasagiline

              rasagiline increases toxicity of vortioxetine by serotonin levels. Contraindicated.

            • selegiline

              selegiline increases toxicity of vortioxetine by serotonin levels. Contraindicated.

            • selegiline transdermal

              selegiline transdermal increases toxicity of vortioxetine by serotonin levels. Contraindicated.

            • tranylcypromine

              tranylcypromine increases toxicity of vortioxetine by serotonin levels. Contraindicated.

            Serious - Use Alternative (78)

            • abametapir

              abametapir will increase the level or effect of vortioxetine 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.

            • alfentanil

              alfentanil, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • almotriptan

              almotriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • amitriptyline

              amitriptyline, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • amoxapine

              amoxapine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • apalutamide

              apalutamide will decrease the level or effect of vortioxetine 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.

            • bupropion

              bupropion, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • carbamazepine

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

            • chlorpromazine

              chlorpromazine increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • citalopram

              citalopram, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • clomipramine

              clomipramine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • cocaine

              cocaine increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • cyclobenzaprine

              cyclobenzaprine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • dabigatran

              vortioxetine and dabigatran both increase anticoagulation. Avoid or Use Alternate Drug.

            • dacomitinib

              dacomitinib will increase the level or effect of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

            • dalteparin

              vortioxetine and dalteparin both increase anticoagulation. Avoid or Use Alternate Drug.

            • desipramine

              desipramine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • desirudin

              vortioxetine and desirudin both increase anticoagulation. Avoid or Use Alternate Drug.

            • desvenlafaxine

              desvenlafaxine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • dexmedetomidine

              dexmedetomidine increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • doxepin

              doxepin, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • duloxetine

              duloxetine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • eletriptan

              eletriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • enzalutamide

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

            • escitalopram

              escitalopram, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fentanyl

              fentanyl, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fentanyl intranasal

              fentanyl intranasal, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fentanyl transdermal

              fentanyl transdermal, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fentanyl transmucosal

              fentanyl transmucosal, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fluoxetine

              fluoxetine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fluvoxamine

              fluvoxamine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • fosphenytoin

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

            • frovatriptan

              frovatriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • givosiran

              givosiran will decrease the level or effect of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2D6 substrates with givosiran. If unavoidable, decrease the CYP2D6 substrate dosage in accordance with approved product labeling.

            • hydromorphone

              hydromorphone, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • idelalisib

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

            • imipramine

              imipramine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • ivosidenib

              ivosidenib will decrease the level or effect of vortioxetine 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.

            • levomilnacipran

              levomilnacipran, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • lithium

              lithium, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • lonafarnib

              lonafarnib will increase the level or effect of vortioxetine 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 increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • lorcaserin

              lorcaserin increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • meperidine

              meperidine, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • milnacipran

              milnacipran, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • mirtazapine

              mirtazapine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • morphine

              morphine, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • naratriptan

              naratriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • nefazodone

              nefazodone, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • nortriptyline

              nortriptyline, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • paroxetine

              paroxetine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • phenobarbital

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

            • phenytoin

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

            • primidone

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

            • protriptyline

              protriptyline, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • quinidine

              quinidine increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • quinine

              quinine increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • remifentanil

              remifentanil, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • ritonavir

              ritonavir increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • rizatriptan

              rizatriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • secobarbital

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

            • sertraline

              sertraline, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • St John's Wort

              St John's Wort, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • sufentanil

              sufentanil, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • sufentanil SL

              sufentanil SL, vortioxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.

            • sumatriptan

              sumatriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • sumatriptan intranasal

              sumatriptan intranasal, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • tedizolid

              tedizolid, vortioxetine. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.

            • tipranavir

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

            • tramadol

              tramadol, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • trazodone

              trazodone increases toxicity of vortioxetine by serotonin levels. Avoid or Use Alternate Drug.

            • trimipramine

              trimipramine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • tucatinib

              tucatinib will increase the level or effect of vortioxetine 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.

            • venlafaxine

              venlafaxine, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • verapamil

              verapamil, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • vilazodone

              vilazodone, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            • voxelotor

              voxelotor will increase the level or effect of vortioxetine 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.

            • zolmitriptan

              zolmitriptan, vortioxetine. Either increases effects of the other by serotonin levels. Avoid or Use Alternate Drug.

            Monitor Closely (103)

            • abciximab

              abciximab, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • alteplase

              alteplase, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • anagrelide

              anagrelide, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • antithrombin III

              vortioxetine and antithrombin III both increase anticoagulation. Use Caution/Monitor.

            • apixaban

              vortioxetine and apixaban both increase anticoagulation. Use Caution/Monitor.

            • argatroban

              vortioxetine and argatroban both increase anticoagulation. Use Caution/Monitor.

            • aspirin

              aspirin, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Risk minimal with low-dose aspirin.

            • aspirin rectal

              aspirin rectal, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Risk minimal with low-dose aspirin.

            • betrixaban

              vortioxetine, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor. SSRIs may inhibit platelet aggregation, thus increase bleeding risk when coadministered with anticoagulants.

            • bivalirudin

              vortioxetine and bivalirudin both increase anticoagulation. Use Caution/Monitor.

            • bosentan

              bosentan decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

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

            • carbamazepine

              carbamazepine decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • celecoxib

              celecoxib, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • choline magnesium trisalicylate

              choline magnesium trisalicylate, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • cilostazol

              cilostazol, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • cinacalcet

              cinacalcet increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Decrease vortioxetine dose by 50% when coadministered with strong CYP2D6 inhibitors.

            • clonidine

              clonidine, vortioxetine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.

            • clopidogrel

              clopidogrel, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • dabrafenib

              dabrafenib decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

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

            • darunavir

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

            • desirudin

              desirudin, vortioxetine. Either increases effects of the other by serotonin levels. Use Caution/Monitor.

            • dexamethasone

              dexamethasone decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • diazepam intranasal

              diazepam intranasal, vortioxetine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.

            • diclofenac

              diclofenac, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • diflunisal

              diflunisal, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • dipyridamole

              dipyridamole increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.

            • efavirenz

              efavirenz decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • elagolix

              elagolix decreases levels of vortioxetine 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.

            • eliglustat

              eliglustat increases levels of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the concomitant drug and titrate to clinical effect.

            • encorafenib

              encorafenib, vortioxetine. 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.

            • enoxaparin

              vortioxetine and enoxaparin both increase anticoagulation. Use Caution/Monitor.

            • enzalutamide

              enzalutamide decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • eptifibatide

              eptifibatide increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.

            • eslicarbazepine acetate

              eslicarbazepine acetate increases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • etodolac

              etodolac, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • etravirine

              etravirine decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

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

            • fedratinib

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

              fedratinib will increase the level or effect of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP2D6 substrates as necessary.

            • fenfluramine

              fenfluramine, vortioxetine. Either increases effects of the other by serotonin levels. Use Caution/Monitor. Coadministration with drugs that increase serotoninergic effects may increase the risk of serotonin syndrome.

            • fenoprofen

              fenoprofen, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • fish oil

              fish oil, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • fish oil triglycerides

              fish oil triglycerides will increase the level or effect of vortioxetine by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.

            • flurbiprofen

              flurbiprofen, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • fondaparinux

              vortioxetine and fondaparinux both increase anticoagulation. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • gabapentin

              gabapentin, vortioxetine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • gabapentin enacarbil

              gabapentin enacarbil, vortioxetine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • garlic

              garlic, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • heparin

              vortioxetine and heparin both increase anticoagulation. Use Caution/Monitor.

            • ibrutinib

              ibrutinib will increase the level or effect of vortioxetine by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.

            • ibuprofen

              ibuprofen, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • ibuprofen IV

              ibuprofen IV, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • indinavir

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

            • indomethacin

              indomethacin, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of vortioxetine 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.

            • ketoprofen

              ketoprofen, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • ketorolac

              ketorolac, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • ketorolac intranasal

              ketorolac intranasal, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • lasmiditan

              lasmiditan, vortioxetine. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

            • lorlatinib

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

            • meclofenamate

              meclofenamate, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • mefenamic acid

              mefenamic acid, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • meloxicam

              meloxicam, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • metformin

              vortioxetine increases effects of metformin by pharmacodynamic synergism. Use Caution/Monitor.

            • mifepristone

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

            • mitotane

              mitotane decreases levels of vortioxetine 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.

            • nabumetone

              nabumetone, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • nafcillin

              nafcillin decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

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

            • naproxen

              naproxen, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • nevirapine

              nevirapine decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • omega 3 carboxylic acids

              omega 3 carboxylic acids, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

            • omega 3 fatty acids

              omega 3 fatty acids, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • oxaprozin

              oxaprozin, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • oxcarbazepine

              oxcarbazepine increases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • pentobarbital

              pentobarbital increases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • pentosan polysulfate sodium

              pentosan polysulfate sodium, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • phenobarbital

              phenobarbital increases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • phenytoin

              phenytoin increases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • piroxicam

              piroxicam, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • prasugrel

              prasugrel increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.

            • pregabalin

              pregabalin, vortioxetine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

            • primidone

              primidone increases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

            • protein C concentrate

              protein C concentrate, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • remimazolam

              remimazolam, vortioxetine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

            • reteplase

              reteplase, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • rifabutin

              rifabutin decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

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

            • rifampin

              rifampin decreases levels of vortioxetine by increasing metabolism. Modify Therapy/Monitor Closely. Consider increasing the vortioxetine dose when coadministered with strong CYP inducers for >14 days; not to exceed 3 times original vortioxetine dose.

              rifampin will decrease the level or effect of vortioxetine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider increasing vortioxetine dose when coadministered with a strong CYP inducer for >14 days. Do not exceed 3x the original dose. Reduce vortioxetine dose to original level within 14 days, when inducer is discontinued.

            • rifapentine

              rifapentine will decrease the level or effect of vortioxetine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • rivaroxaban

              rivaroxaban, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • rolapitant

              rolapitant will increase the level or effect of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Rolapitant may increase plasma concentrations of CYP2D6 substrates for at least 28 days following rolapitant administration.

            • rucaparib

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

            • salsalate

              salsalate, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • stiripentol

              stiripentol, vortioxetine. 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.

            • sulindac

              sulindac, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • tazemetostat

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

            • tecovirimat

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

            • tenecteplase

              tenecteplase, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • terbinafine

              terbinafine will increase the level or effect of vortioxetine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Assess need to reduce dose of CYP2D6-metabolized drug.

            • ticlopidine

              ticlopidine increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.

            • tirofiban

              tirofiban increases effects of vortioxetine by anticoagulation. Use Caution/Monitor.

            • tolmetin

              tolmetin, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • vitamin E

              vitamin E, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • vorapaxar

              vortioxetine, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

            • warfarin

              warfarin, vortioxetine. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            Minor (1)

            • ribociclib

              ribociclib will increase the level or effect of vortioxetine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Nausea (21-32%)

            1-10%

            Diarrhea (7-10%)

            Dizziness (6-9%)

            Dry mouth (6-8%)

            Constipation (3-6%)

            Vomiting (3-6%)

            Flatulence (1-3%)

            Pruritus (1-3%)

            Abnormal dreams (<1-3%)

            Postmarketing Reports

            Weight gain

            Acute pancreatitis

            Angle closure glaucoma

            Seizure

            Rash, generalized rash

            Difficulties in sexual desire, sexual performance, and sexual satisfaction

            Aggression, agitation, anger, hostility, irritability

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            Warnings

            Black Box Warnings

            Suicidal thoughts and behaviors

            • Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies
            • Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors
            • Not approved for use in pediatric patients

            Contraindications

            Hypersensitivity to vortioxetine or any component of formulation

            MAOI

            • Use of MAOIs (intended to treat psychiatric disorders) or within 21 days of discontinuing with vortioxetine
            • Use of vortioxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders
            • Currently being treated with another MAOI (eg, linezolid, IV methylene blue)

            Cautions

            May worsen mania symptoms or activate mania/hypomania in patients with bipolar disorder

            Risk of mydriasis; may trigger angle closure attack in patients with angle-closure glaucoma with anatomically narrow angles without a patent iridectomy

            Increases risk of hyponatremia and cognitive impairment especially in the elderly; hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH); patients taking diuretics or who are otherwise volume-depleted can be at greater risk; consider discontinuation of drug in patients with symptomatic hyponatremia; appropriate medical intervention should be instituted

            Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers because these patients have higher vortioxetine plasma concentrations than extensive CYP2D6 metabolizers

            Suicidal thoughts and behaviors in adolescents and young adults

            • In pooled studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for MDD and other psychiatric illnesses
            • Variations in risk of suicidal thoughts and behaviors among drugs and across the different indications, highest incidence in patients with MDD
            • Unknown if risk extends to longer-term use
            • Closely monitor for behavioral changes, clinical worsening, and suicidal tendencies during initial 1-2 months of therapy and dosage adjustments
            • Counsel family members or caregivers to monitor for changes in behavior and to alert the healthcare provider; consider changing the therapeutic regimen, including possibly discontinuing therapy, in patients whose depression is persistently worse, or who are experiencing emergent of suicidal thoughts and behaviors

            Serotonin syndrome

            • Serotonin syndrome reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with vortioxetine, both when taken alone, but especially when coadministered with other serotonergic agents (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort)
            • Symptoms include mental status changes, autonomic instability, neuromuscular symptoms, seizures, and/or gastrointestinal symptoms
            • If symptoms occur, discontinue therapy and initiate supportive treatment
            • If concomitant use with other serotonergic drugs is clinically warranted, advise of potential risks for serotonin syndrome, particularly during treatment initiation and dose increases

            Discontinuation syndrome

            • Adverse reactions reported upon abrupt discontinuation of treatment at doses of 15-20 mg/day
            • Gradual reduction in dosage is recommended whenever possible
            • Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances, tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures

            Drug interaction overview

            • Substrate of CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8 and CYP2B6
            • Increase of serotonin syndrome
              • Contraindicated with MAOIs
              • Coadministration with serotonergic drugs increases the risk of serotonin syndrome
              • Monitor; if serotonin syndrome occurs, consider discontinuing vortioxetine
            • Strong CYP2D6 inhibitor
              • Coadministration with strong CYP2D6 inhibitors increases plasma concentrations of vortioxetine
            • Strong CYP inducers
              • Coadministration with strong CYP2D6 inhibitors decreases plasma concentrations of vortioxetine
            • Drugs that interfere coagulation or bleeding
              • Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase risk of abnormal bleeding
              • Exercise caution with concomitant use of vortioxetine with nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or other drugs that affect coagulation
              • Monitor INR when used with warfarin
            • Drugs highly bound to plasma protein
              • Coadministration of vortioxetine with drugs highly bound to plasma protein (eg, warfarin) may increase free concentrations of vortioxetine or other highly bound drugs in plasma
              • Monitor for adverse reactions and reduce dosage of both protein bound drugs as needed
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            Pregnancy & Lactation

            Pregnancy

            Limited human data available on use during pregnancy to inform any drug-associated risks

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1- 844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/

            Animal data

            • Administered to pregnant rats and rabbits during organogenesis at doses ≥15 times and 10x the maximum recommended human dose (MRHD), respectively, resulted in decreased fetal body weight and delayed ossification
            • No malformations were seen at doses up to 77x and 58x the MRHD, respectively
            • Orally administered to pregnant rats during gestation and lactation at doses ≥20x the MRHD resulted in a decrease in the number of live-born pups and an increase in early postnatal pup mortality
            • Decreased pup weight at birth to weaning occurred at 58x the MRHD and delayed physical development occurred at ≥20 times the MRHD
            • Advise pregnant females of the potential risk to a fetus

            Clinical consideration

            • Women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants; consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum
            • Exposure to serotonergic antidepressants, including vortioxetine, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN); monitor neonates who were exposed to drug in the third trimester of pregnancy for PPHN and drug discontinuation syndrome

            Lactation

            There is no information regarding presence of vortioxetine in human milk, effects on the breastfed infant, or effects on milk production

            Present in rat milk

            Consider developmental and health benefits of breastfeeding along with mother's clinical need for therapy and any potential adverse effects on breastfed child from therapy or from 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

            The mechanism of the antidepressant effect is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT)

            It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism; the contribution of these activities to the antidepressant effect has not been established

            Absorption

            Peak plasma concentration at steady-state: 9 ng/mL (5 mg/day), 18ng/mL (10 mg/day), 33 ng/mL (20 mg/day)

            Peak plasma time: 7-11 hr

            Absolute bioavailability: 75%

            Distribution

            Protein bound: 98%

            Vd: 2,600 L (extensive extravascular distribution)

            Metabolism

            Extensively metabolized primarily through oxidation via CYP450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8 and CYP2B6 and subsequent glucuronic acid conjugation

            CYP2D6 is the primary metabolic pathway

            Metabolites: Carboxylic acid metabolite (inactive)

            Elimination

            Half-life: 66 hr

            Excretion: 59% urine; 26% feces

            Pharmacogenomics

            Poor metabolizers of CYP2D6 have ~twice the vortioxetine plasma concentration of extensive metabolizers

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            Administration

            Oral Administration

            Take with or without food

            Storage

            Store at 77ºF (25ºC); excursions permitted to 59-86ºF (15-30ºC)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Trintellix oral
            -
            20 mg tablet
            Trintellix oral
            -
            10 mg tablet
            Trintellix oral
            -
            5 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            vortioxetine oral

            VORTIOXETINE - ORAL

            (VOR-tye-OX-e-teen)

            COMMON BRAND NAME(S): Trintellix

            WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

            USES: This medication is used to treat depression. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Vortioxetine is an SSRI (selective serotonin reuptake inhibitor) and serotonin receptor modulator. This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking vortioxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition, response to treatment and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, muscle stiffness, and runny nose. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.It may take up to several weeks before you get the full benefit of this drug.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: See also Warning section.Nausea, constipation, vomiting, dizziness, decreased interest in sex, and changes in sexual ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she 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.Tell your doctor right away if you have any serious side effects, including: shaking (tremor), restlessness, inability to keep still, numbness/tingling, easy bruising/bleeding, difficulty concentrating, memory changes, confusion, weakness.Get medical help right away if you have any very serious side effects, including: seizures, black stools, vomit that looks like coffee grounds, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.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 taking vortioxetine, 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: personal or family history of bipolar/manic-depressive disorder, personal or family history of suicide attempts, seizures, low sodium in the blood, intestinal ulcers/bleeding (peptic ulcer disease) or bleeding problems, personal or family history of glaucoma (angle-closure type).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially bleeding. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.Since untreated mental/mood problems (such as depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.It is unknown if this drug passes into breast milk. 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: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin/dabigatran).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for 2 weeks before and 21 days after treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including other SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

            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.Keep all regular medical and psychiatric appointments. Medical/psychiatric check-ups should be done periodically to monitor your progress or check for side effects.

            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 March 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.

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            • View the formulary and any restrictions for each plan.
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            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
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            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.