valbenazine (Rx)

Brand and Other Names:Ingrezza

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 40mg
  • 60mg
  • 80mg

Tardive Dyskinesia

Indicated for treatment of adults with tardive dyskinesia

40 mg PO qDay x1 week, then increase to the recommended dose of 80 mg PO qDay

40-60 mg qDay may be considered depending on response and tolerability

Chorea

Indicated for chorea associated with Huntington disease

40 mg PO qDay, initially

Increase in 20 mg increments q2Weeks to recommended dosage of 80 mg qDay

May consider 40 mg or 60 mg qDay depending on response and tolerability

Dosage Modifications

Strong CYP3A4 inducers: Coadministration not recommended

Strong CYP3A4 inhibitors: If coadministered, reduce valbenazine dose to 40 mg/day

Strong CYP2D6 inhibitors or known CYP2D6 poor metabolizers: If coadministered, reduce valbenazine dose to 40 mg/day

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate-to-severe (Child-Pugh 7-15): Not to exceed 40 mg/day

Renal impairment

  • Mild-to-severe: No dose adjustment required

Tardive dyskinesia: Safety and efficacy not established

Tourette Syndrome (Orphan)

Orphan designation for treatment of Tourette syndrome

Sponsor

  • Neurocrine Biosciences, Inc; 12780 El Camino Real; San Diego, California 92130
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Interactions

Interaction Checker

and valbenazine

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            Contraindicated (2)

            • deutetrabenazine

              deutetrabenazine, valbenazine. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Do not use these drugs concomitantly.

            • tetrabenazine

              tetrabenazine, valbenazine. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Do not use these drugs concomitantly.

            Serious - Use Alternative (42)

            • apalutamide

              apalutamide will decrease the level or effect of valbenazine 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.

            • butalbital

              butalbital will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • carbamazepine

              carbamazepine will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • ceritinib

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

            • cobicistat

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

            • dabrafenib

              dabrafenib will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • dacomitinib

              dacomitinib will increase the level or effect of valbenazine 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.

            • dexamethasone

              dexamethasone will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • enzalutamide

              enzalutamide will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • fexinidazole

              fexinidazole will increase the level or effect of valbenazine 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.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • givosiran

              givosiran will increase the level or effect of valbenazine 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.

            • iobenguane I 131

              valbenazine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.

            • isocarboxazid

              isocarboxazid, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • ivosidenib

              ivosidenib will decrease the level or effect of valbenazine 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.

            • linezolid

              linezolid, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • lonafarnib

              lonafarnib will increase the level or effect of valbenazine 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.

            • lumacaftor/ivacaftor

              lumacaftor/ivacaftor will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • methylene blue

              methylene blue, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • mifepristone

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

            • mitotane

              mitotane will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • nevirapine

              nevirapine will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • pentobarbital

              pentobarbital will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • phenelzine

              phenelzine, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • phenobarbital

              phenobarbital will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • phenytoin

              phenytoin will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • primidone

              primidone will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • rasagiline

              rasagiline, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • ribociclib

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

            • rifabutin

              rifabutin will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • rifampin

              rifampin will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • rifapentine

              rifapentine will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • safinamide

              safinamide, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • secobarbital

              secobarbital will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • selegiline

              selegiline, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • selegiline transdermal

              selegiline transdermal, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • St John's Wort

              St John's Wort will decrease the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use not recommended.

            • tranylcypromine

              tranylcypromine, valbenazine. Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of valbenazine with MAOIs may increase monoamine neurotransmitter concentration in synapses, potentially increasing risk of serotonin syndrome or attenuating valbenazine effect.

            • tucatinib

              tucatinib will increase the level or effect of valbenazine 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.

            • voxelotor

              voxelotor will increase the level or effect of valbenazine 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 (195)

            • albuterol

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

            • alfuzosin

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

            • amiodarone

              valbenazine and amiodarone both increase QTc interval. Use Caution/Monitor.

            • amisulpride

              valbenazine and amisulpride both increase QTc interval. Use Caution/Monitor.

            • amitriptyline

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

            • amobarbital

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

            • amoxapine

              valbenazine and amoxapine both increase QTc interval. Use Caution/Monitor.

            • anagrelide

              valbenazine and anagrelide both increase QTc interval. Use Caution/Monitor.

            • apomorphine

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

            • arformoterol

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

            • aripiprazole

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

            • arsenic trioxide

              valbenazine and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • artemether

              valbenazine and artemether both increase QTc interval. Use Caution/Monitor.

            • artemether/lumefantrine

              valbenazine and artemether/lumefantrine both increase QTc interval. Use Caution/Monitor.

            • asenapine

              valbenazine and asenapine both increase QTc interval. Use Caution/Monitor.

            • atazanavir

              atazanavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg daily when coadministered with strong CYP3A4 inhibitors.

            • atomoxetine

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

            • azithromycin

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

            • bedaquiline

              valbenazine and bedaquiline both increase QTc interval. Use Caution/Monitor.

            • bosentan

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

            • buprenorphine

              valbenazine and buprenorphine both increase QTc interval. Use Caution/Monitor.

            • bupropion

              bupropion will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

            • ceritinib

              valbenazine and ceritinib both increase QTc interval. Use Caution/Monitor.

            • chloramphenicol

              chloramphenicol will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose when coadministered with a strong CYP3A4 inhibitor.

            • chloroquine

              valbenazine and chloroquine both increase QTc interval. Use Caution/Monitor.

            • chlorpromazine

              chlorpromazine will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

              valbenazine and chlorpromazine both increase QTc interval. Use Caution/Monitor.

            • cinacalcet

              cinacalcet will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

            • ciprofloxacin

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

            • cisapride

              valbenazine and cisapride both increase QTc interval. Use Caution/Monitor.

            • citalopram

              valbenazine and citalopram both increase QTc interval. Use Caution/Monitor.

            • clarithromycin

              clarithromycin will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

              valbenazine and clarithromycin both increase QTc interval. Use Caution/Monitor.

            • clomipramine

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

            • clozapine

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

            • cobicistat

              cobicistat will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2E1 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • cocaine topical

              cocaine topical will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

            • conivaptan

              conivaptan will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • crizotinib

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

            • darunavir

              darunavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • dasatinib

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

            • degarelix

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

            • desflurane

              valbenazine and desflurane both increase QTc interval. Use Caution/Monitor.

            • desipramine

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

            • deutetrabenazine

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

            • dexmedetomidine

              dexmedetomidine will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

            • disopyramide

              valbenazine and disopyramide both increase QTc interval. Use Caution/Monitor.

            • dofetilide

              valbenazine and dofetilide both increase QTc interval. Use Caution/Monitor.

            • dolasetron

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

            • donepezil

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

            • doxepin

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

            • dronedarone

              valbenazine and dronedarone both increase QTc interval. Use Caution/Monitor.

            • droperidol

              valbenazine and droperidol both increase QTc interval. Use Caution/Monitor.

            • duvelisib

              duvelisib will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

            • efavirenz

              valbenazine and efavirenz both increase QTc interval. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of valbenazine 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

              valbenazine and eliglustat both increase QTc interval. Use Caution/Monitor.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • encorafenib

              encorafenib, valbenazine. 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.

              valbenazine and encorafenib both increase QTc interval. Use Caution/Monitor.

            • entrectinib

              valbenazine and entrectinib both increase QTc interval. Use Caution/Monitor.

            • eribulin

              valbenazine and eribulin both increase QTc interval. Use Caution/Monitor.

            • erythromycin base

              valbenazine and erythromycin base both increase QTc interval. Use Caution/Monitor.

            • erythromycin ethylsuccinate

              valbenazine and erythromycin ethylsuccinate both increase QTc interval. Use Caution/Monitor.

            • erythromycin lactobionate

              valbenazine and erythromycin lactobionate both increase QTc interval. Use Caution/Monitor.

            • erythromycin stearate

              valbenazine and erythromycin stearate both increase QTc interval. Use Caution/Monitor.

            • escitalopram

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

            • etravirine

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

            • fedratinib

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

            • fexinidazole

              valbenazine and fexinidazole both increase QTc interval. Use Caution/Monitor.

            • fingolimod

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

            • flecainide

              valbenazine and flecainide both increase QTc interval. Use Caution/Monitor.

            • fluconazole

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

            • fluoxetine

              fluoxetine will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

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

            • fluphenazine

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

            • fluvoxamine

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

            • fosamprenavir

              fosamprenavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • foscarnet

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

            • fostemsavir

              valbenazine and fostemsavir both increase QTc interval. Use Caution/Monitor.

            • ganaxolone

              valbenazine and ganaxolone both increase sedation. Use Caution/Monitor.

            • gemifloxacin

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

            • gemtuzumab

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

            • gilteritinib

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

            • glasdegib

              valbenazine and glasdegib both increase QTc interval. Use Caution/Monitor.

            • goserelin

              valbenazine and goserelin both increase QTc interval. Use Caution/Monitor.

            • granisetron

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

            • grapefruit

              grapefruit will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • haloperidol

              valbenazine and haloperidol both increase QTc interval. Use Caution/Monitor.

            • histrelin

              valbenazine and histrelin both increase QTc interval. Use Caution/Monitor.

            • hydroxychloroquine sulfate

              valbenazine and hydroxychloroquine sulfate both increase QTc interval. Use Caution/Monitor.

            • hydroxyzine

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

            • ibutilide

              valbenazine and ibutilide both increase QTc interval. Use Caution/Monitor.

            • idelalisib

              idelalisib will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • iloperidone

              valbenazine and iloperidone both increase QTc interval. Use Caution/Monitor.

            • imatinib

              imatinib will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • imipramine

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

            • indacaterol, inhaled

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

            • indinavir

              indinavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • inotuzumab

              valbenazine and inotuzumab both increase QTc interval. Use Caution/Monitor.

            • isoflurane

              valbenazine and isoflurane both increase QTc interval. Use Caution/Monitor.

            • isoniazid

              isoniazid will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • istradefylline

              istradefylline will increase the level or effect of valbenazine 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 valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

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

            • ivosidenib

              valbenazine and ivosidenib both decrease QTc interval. Use Caution/Monitor.

            • ketoconazole

              ketoconazole will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • lapatinib

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

            • lefamulin

              valbenazine and lefamulin both increase QTc interval. Use Caution/Monitor.

            • lenacapavir

              lenacapavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.

            • lenvatinib

              valbenazine and lenvatinib both increase QTc interval. Use Caution/Monitor.

            • leuprolide

              valbenazine and leuprolide both increase QTc interval. Use Caution/Monitor.

            • levalbuterol

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

            • levofloxacin

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

            • levoketoconazole

              levoketoconazole will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • lithium

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

            • lofexidine

              valbenazine and lofexidine both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended.

            • loperamide

              valbenazine and loperamide both increase QTc interval. Use Caution/Monitor.

            • lopinavir

              lopinavir will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

              lopinavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

              valbenazine and lopinavir both increase QTc interval. Use Caution/Monitor.

            • lorcaserin

              lorcaserin will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

            • lorlatinib

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

            • macimorelin

              valbenazine and macimorelin both increase QTc interval. Use Caution/Monitor.

            • maprotiline

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

            • mefloquine

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

            • methadone

              valbenazine and methadone both increase QTc interval. Use Caution/Monitor.

            • midostaurin

              valbenazine and midostaurin both increase QTc interval. Use Caution/Monitor.

            • mifepristone

              valbenazine and mifepristone both increase QTc interval. Use Caution/Monitor.

            • mirtazapine

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

            • mobocertinib

              valbenazine and mobocertinib both increase QTc interval. Use Caution/Monitor.

            • moxifloxacin

              valbenazine and moxifloxacin both increase QTc interval. Use Caution/Monitor.

            • nafcillin

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

            • nefazodone

              nefazodone will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • nelfinavir

              nelfinavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • nicardipine

              nicardipine will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • nilotinib

              valbenazine and nilotinib both increase QTc interval. Use Caution/Monitor.

            • nortriptyline

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

            • octreotide

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

            • ofloxacin

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

            • olanzapine

              valbenazine and olanzapine both increase QTc interval. Use Caution/Monitor.

            • olodaterol inhaled

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

            • ondansetron

              valbenazine and ondansetron both increase QTc interval. Use Caution/Monitor.

            • osilodrostat

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

            • osimertinib

              valbenazine and osimertinib both increase QTc interval. Use Caution/Monitor.

            • oxaliplatin

              valbenazine and oxaliplatin both increase QTc interval. Use Caution/Monitor.

            • ozanimod

              valbenazine and ozanimod both increase QTc interval. Use Caution/Monitor.

            • paliperidone

              valbenazine and paliperidone both increase QTc interval. Use Caution/Monitor.

            • panobinostat

              valbenazine and panobinostat both increase QTc interval. Use Caution/Monitor.

            • paroxetine

              paroxetine will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

              valbenazine and paroxetine both increase QTc interval. Use Caution/Monitor.

            • pasireotide

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

            • pazopanib

              valbenazine and pazopanib both increase QTc interval. Use Caution/Monitor.

            • pentamidine

              valbenazine and pentamidine both increase QTc interval. Use Caution/Monitor.

            • perphenazine

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

            • pimavanserin

              valbenazine and pimavanserin both increase QTc interval. Use Caution/Monitor.

            • pimozide

              valbenazine and pimozide both increase QTc interval. Use Caution/Monitor.

            • pitolisant

              valbenazine and pitolisant both increase QTc interval. Use Caution/Monitor.

            • ponesimod

              valbenazine and ponesimod both increase QTc interval. Use Caution/Monitor.

            • posaconazole

              posaconazole will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

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

            • primaquine

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

            • procainamide

              valbenazine and procainamide both increase QTc interval. Use Caution/Monitor.

            • prochlorperazine

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

            • promethazine

              valbenazine and promethazine both decrease QTc interval. Use Caution/Monitor.

            • propafenone

              valbenazine and propafenone both increase QTc interval. Use Caution/Monitor.

            • protriptyline

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

            • quinidine

              quinidine will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

            • ranolazine

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

            • remimazolam

              remimazolam, valbenazine. 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.

            • rilpivirine

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

            • risperidone

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

            • ritonavir

              ritonavir will increase the level or effect of valbenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Consider reducing valbenazine dose based on tolerability if coadministered with a strong CYP2D6 inhibitor.

              ritonavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • rolapitant

              rolapitant will increase the level or effect of valbenazine 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.

            • romidepsin

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

            • rucaparib

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

            • salmeterol

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

            • saquinavir

              saquinavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

              valbenazine and saquinavir both increase QTc interval. Use Caution/Monitor.

            • selpercatinib

              valbenazine and selpercatinib both increase QTc interval. Use Caution/Monitor.

            • sertraline

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

            • sevoflurane

              valbenazine and sevoflurane both increase QTc interval. Use Caution/Monitor.

            • siponimod

              valbenazine and siponimod both increase QTc interval. Use Caution/Monitor.

            • solifenacin

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

            • sorafenib

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

            • stiripentol

              stiripentol, valbenazine. 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.

            • sunitinib

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

            • tacrolimus

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

            • tazemetostat

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

            • tecovirimat

              tecovirimat will decrease the level or effect of valbenazine 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

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

            • terbinafine

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

            • tipranavir

              tipranavir will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

            • trazodone

              valbenazine and trazodone both increase QTc interval. Use Caution/Monitor.

            • trifluoperazine

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

            • trimipramine

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

            • triptorelin

              valbenazine and triptorelin both increase QTc interval. Use Caution/Monitor.

            • umeclidinium bromide/vilanterol inhaled

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

            • vandetanib

              valbenazine and vandetanib both increase QTc interval. Use Caution/Monitor.

            • vardenafil

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

            • vemurafenib

              valbenazine and vemurafenib both increase QTc interval. Use Caution/Monitor.

            • venlafaxine

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

            • vilanterol/fluticasone furoate inhaled

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

            • voriconazole

              voriconazole will increase the level or effect of valbenazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Reduce valbenazine dose to 40 mg once daily when coadministered with a strong CYP3A4 inhibitor.

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

            • vorinostat

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

            Minor (4)

            • acetazolamide

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

            • anastrozole

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

            • cyclophosphamide

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

            • larotrectinib

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

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            Adverse Effects

            >10%

            Somnolence (10.9%)

            1-10%

            Anticholinergic effects (5.4%)

            Balance disorders/fall (4.1%)

            Headache (3.4%)

            Akathisia (2.7%)

            Vomiting (2.6%)

            Nausea (2.3%)

            Arthralgia (2.3%)

            Postmarketing Reports

            Hypersensitivity

            QT prolongation

            Skin and subcutaneous tissue disorders: rash

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            Warnings

            Black Box Warnings

            Depression and suicidal ideation and behavior in Huntington disease

            • VMAT2 inhibitors, including this drug, can increase risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease
            • Anyone considering this therapy must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea
            • Closely monitor patients for emergence or worsening of depression, suicidal ideation, or unusual changes in behavior
            • Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician
            • Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease
            • If any of the reactions associated with suicide occur and do not resolve, consider discontinuing therapy

            Contraindications

            History of hypersensitivity to drug or components

            Cautions

            Can cause somnolence; warn patients not to perform activities requiring mental alertness (eg, driving or operating hazardous machinery) until they know how they will be affected

            Increased exposure (Cmax and AUC) to active metabolite is anticipated in CYP2D6 poor metabolizers; increased exposure of active metabolite may increase risk of exposure-related adverse reactions; dose reduction recommended

            Patients with Huntington disease are at increased risk for depression, and suicidal ideation or behaviors (see Black Box Warnings)

            Hypersensitivity reactions, including angioedema involving the larynx, glottis, lips, and eyelids, reported in the post-marketing setting in patients after taking the first or subsequent doses; angioedema associated with laryngeal edema can be fatal; if any of the hypersensitivity reactions occur, discontinue therapy (see Contraindications)

            Parkinsonism

            • May cause parkinsonism in patients with tardive dyskinesia
            • Also reported with other VMAT2 inhibitors
            • Postmarketing safety reports have described parkinson-like symptoms that required hospitalization
            • In most cases, severe parkinsonism occurred within first two weeks of initiating or increasing dose of drug
            • Associated symptoms have included falls, gait disturbances, tremor, drooling and hypokinesia
            • In cases in which follow-up clinical information was available, parkinson-like symptoms were reported to resolve following discontinuation of therapy
            • Reduce dose or discontinue treatment in patients who develop clinically significant parkinson-like signs or symptoms

            QT prolongation

            • May prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing
            • If coadministered with a strong CYP2D6 or CYP3A4 inhibitor, or patients who are CYP2D6 poor metabolizers, valbenazine concentrations may increase and cause clinically significant QT prolongation (see Dosage Modifications)
            • Avoid in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval
            • For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage

            Neuroleptic malignant syndrome (NMS)

            • A potentially fatal complex known as NMS has been reported in association with drugs that reduce dopaminergic transmission
            • Clinical manifestations are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia)
            • Additional signs may include elevated creatine phosphokinase, myoglobinuria, rhabdomyolysis, and acute renal failure
            • Management includes
              • Immediate discontinuation of valbenazine
              • Intensive symptomatic treatment and medical monitoring
              • Treatment of any concomitant serious medical problems for which specific treatments are available
              • If treatment is needed after recovery from NMS, monitor for signs of recurrence

            Drug interaction overview

            • MAOIs
              • Avoid coadministration
              • Concomitant use may increase concentration of monoamine neurotransmitters in synapses, potentially leading to increased risk of adverse reactions (eg, serotonin syndrome) or attenuated treatment effect of valbenazine
            • Strong CYP3A4 inhibitors
              • Reduce valbenazine dose (see Dosage Modifications)
              • Coadministration increases exposure (Cmax and AUC) to valbenazine and its active metabolite compared with the use of valbenazine alone
            • Strong CYP2D6 inhibitors
              • Reduce valbenazine dose (see Dosage Modifications)
              • Coadministration increases exposure (Cmax and AUC) to valbenazine’s active metabolite compared with the use of valbenazine alone
            • Strong CYP3A4 inducers
              • Concomitant use not recommended
              • Coadministration decreases systemic exposure of valbenazine and its active metabolite, thereby decreasing efficacy
            • Digoxin
              • Coadministration increases digoxin levels owing to P-gp inhibition
              • Monitor digoxin levels if coadministered; dosage adjustment of digoxin may be necessary
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            Pregnancy

            Pregnancy

            Data are limited on use in pregnant women

            Based on animal studies, may cause fetal harm; advise pregnant women of the potential risk

            Animal studies

            • Administration to pregnant rats during organogenesis through lactation produced an increase in the number of stillborn pups and postnatal pup mortalities at doses <1 times the maximum recommended human dose (MRHD) of 80 mg/day based on mg/m² body surface area
            • However, no malformations were observed when administered orally to rats and rabbits during the period of organogenesis at doses up to 1.8 or 24 times, respectively, the MRHD

            Lactation

            Unknown if distributed in human breast milk

            Valbenazine and its metabolites have been detected in rat milk at concentrations higher than in plasma following oral administration at doses 0.1-1.2 times the MRHD based on mg/m²

            Based on animal findings of increased perinatal mortality in exposed fetuses and pups, advise a woman not to breastfeed during treatment and for 5 days after the final 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

            The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release

            Absorption

            Bioavailability: ~49%

            Peak plasma time: 0.5-1 hr (parent); 4-8 hr (active metabolite)

            Steady-state: 1 week

            Distribution

            Protein bound: >99% (parent); ~64% (active metabolite)

            Vd: 92 L

            Metabolism

            Extensively metabolized after oral administration by hydrolysis of the valine ester to form the active metabolite ([+]-alpha-HTBZ) and by oxidative metabolism, primarily by CYP3A4/5, to form mono-oxidized valbenazine and other minor metabolites

            [+]-alpha-HTBZ appears to be further metabolized in part by CYP2D6

            Elimination

            Half-life: 15-22 hr (parent drug and active metabolite)

            Total plasma clearance: 7.2 L/hr

            Excretion: 60% urine; 30% feces; <2% excreted as unchanged valbenazine or [+]-alpha-HTBZ

            Pharmacogenomics

            CYP2D6 poor metabolizers

            • Consider reducing valbenazine dose based on tolerability for known CYP2D6 poor metabolizers
            • Increased exposure (Cmax and AUC) to the active metabolite is anticipated in CYP2D6 poor metabolizers, which may increase risk for exposure-related adverse effects
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            Administration

            Oral Administration

            May take with or without food

            Storage

            Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Ingrezza oral
            -
            80 mg capsule
            Ingrezza oral
            -
            40 mg capsule
            Ingrezza oral
            -
            60 mg capsule
            Ingrezza Initiation Pack oral
            -
            40 mg (7)- 80 mg (21) capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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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
            PA Prior Authorization
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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.