deutetrabenazine (Rx)

Brand and Other Names:Austedo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 6mg
  • 9mg
  • 12mg

Chorea With Huntington Disease

Initial dose when not being switched from tetrabenazine: 6 mg PO qDay

May increase dose at weekly intervals in increments of 6 mg/day; not to exceed 48 mg/day

Administer doses ≥12 mg/day in 2 divided doses

Also see Administration for doses when switching from tetrabenazine

Tardive Dyskinesia (TD)

Initial dose when not being switched from tetrabenazine: 6 mg PO BID

May increase dose at weekly intervals in increments of 6 mg/day; not to exceed 48 mg/day

Also see Administration for doses when switching from tetrabenazine

Dosage Modifications

Strong CYP2D6 inhibitors

  • Deutetrabenazine daily dose: Not to exceed 36 mg/day (maximum single dose of 18 mg)
  • Examples of strong CYP2D6 inhibitors include quinidine and antidepressants (eg, paroxetine, fluoxetine, bupropion)

Poor CYP2D6 metabolizers

  • Deutetrabenazine daily dose: Not to exceed 36 mg/day (maximum single dose of 18 mg)

Hepatic impairment

  • Contraindicated
  • Effect of hepatic impairment on the pharmacokinetics of deutetrabenazine and its primary metabolites has not been studied
  • In a clinical study conducted with tetrabenazine, a closely related VMAT2 inhibitor, there was a large increase in exposure to tetrabenazine and its active metabolites
  • The clinical significance of this increased exposure has not been assessed, but because of concerns for a greater risk for serious adverse reactions, it is contraindicated

Dosing Considerations

Determine dose for each patient based on reduction of chorea or tardive dyskinesia and on tolerability

For patients at risk for QT prolongation, assess QT interval before and after increasing doses to >24 mg/day

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and deutetrabenazine

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            Contraindicated (11)

            • isocarboxazid

              isocarboxazid, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • linezolid

              linezolid, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI. If linezolid must be used, discontinue deutetrabenazine and monitor for adverse effects. Deutetrabenazine may be resumed 24 hours after last linezolid dose or after 2 weeks of monitoring, whichever comes first.

            • methylene blue

              methylene blue, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI. If methylene blue must be used emergently, discontinue deutetrabenazine and monitor for adverse effects. Deutetrabenazine may be resumed 24 hours after last methylene blue dose or after 2 weeks of monitoring, whichever comes first.

            • phenelzine

              phenelzine, deutetrabenazine. Either increases levels of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • rasagiline

              rasagiline, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • safinamide

              safinamide, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • selegiline

              selegiline, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • selegiline transdermal

              selegiline transdermal, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • tetrabenazine

              tetrabenazine, deutetrabenazine. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Do not use these drugs concomitantly. Deutetrabenazine may be initiated the day after discontinuing tetrabenazine.

            • tranylcypromine

              tranylcypromine, deutetrabenazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Contraindicated. Deutetrabenazine should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

            • valbenazine

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

            Serious - Use Alternative (8)

            • fexinidazole

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

            • givosiran

              givosiran will increase the level or effect of deutetrabenazine 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.

            • hydroxychloroquine sulfate

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

            • iobenguane I 131

              deutetrabenazine 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.

            • lefamulin

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

            • metoclopramide intranasal

              deutetrabenazine, metoclopramide intranasal. Either decreases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

            • ribociclib

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

            • safinamide

              deutetrabenazine decreases effects of safinamide by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Dopamine antagonists may decrease safinamide effects and exacerbate Parkinson disease symptoms.

            Monitor Closely (175)

            • abiraterone

              abiraterone will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • acetazolamide

              acetazolamide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • alprazolam

              alprazolam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • amiodarone

              amiodarone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • amitriptyline

              amitriptyline and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • amobarbital

              amobarbital and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • amoxapine

              amoxapine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • anagrelide

              anagrelide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • aripiprazole

              aripiprazole and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              aripiprazole and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • arsenic trioxide

              arsenic trioxide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • artemether

              artemether and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • asenapine

              asenapine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              asenapine and deutetrabenazine both increase sedation. Use Caution/Monitor.

              asenapine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • brexanolone

              brexanolone, deutetrabenazine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

            • brivaracetam

              brivaracetam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • brompheniramine

              brompheniramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • buprenorphine

              buprenorphine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • buprenorphine transdermal

              buprenorphine transdermal and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • bupropion

              bupropion will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • butabarbital

              butabarbital and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • butalbital

              butalbital and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • butorphanol

              butorphanol and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • carbamazepine

              carbamazepine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • carbinoxamine

              carbinoxamine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • cariprazine

              cariprazine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              cariprazine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • cenobamate

              cenobamate, deutetrabenazine. Either increases effects of the other by sedation. Use Caution/Monitor.

            • chloral hydrate

              chloral hydrate and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • chlordiazepoxide

              chlordiazepoxide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • chlorpheniramine

              chlorpheniramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • chlorpromazine

              chlorpromazine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • chlorpropamide

              chlorpropamide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • cinacalcet

              cinacalcet will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • citalopram

              citalopram and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • clemastine

              clemastine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • clofazimine

              clofazimine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • clomipramine

              clomipramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • clonazepam

              clonazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • clorazepate

              clorazepate and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • clozapine

              clozapine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              clozapine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • codeine

              codeine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • cyproheptadine

              cyproheptadine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dacomitinib

              dacomitinib will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • darunavir

              darunavir will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • desipramine

              desipramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dexchlorpheniramine

              dexchlorpheniramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • diazepam

              diazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dimenhydrinate

              dimenhydrinate and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • diphenhydramine

              diphenhydramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • disopyramide

              disopyramide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • dofetilide

              dofetilide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • doxepin

              doxepin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • doxylamine

              doxylamine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • dronedarone

              dronedarone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • eliglustat

              eliglustat and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • encorafenib

              encorafenib and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • entrectinib

              deutetrabenazine and entrectinib both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • escitalopram

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

            • esketamine intranasal

              esketamine intranasal, deutetrabenazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

            • eslicarbazepine acetate

              eslicarbazepine acetate and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • estazolam

              estazolam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • eszopiclone

              eszopiclone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ethanol

              ethanol and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ethosuximide

              ethosuximide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ethotoin

              ethotoin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ezogabine

              ezogabine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fedratinib

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

            • felbamate

              felbamate and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fentanyl

              fentanyl and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fentanyl intranasal

              fentanyl intranasal and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fentanyl transdermal

              fentanyl transdermal and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fentanyl transmucosal

              fentanyl transmucosal and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fluoxetine

              fluoxetine will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • fluphenazine

              fluphenazine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              fluphenazine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • flurazepam

              flurazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • fostemsavir

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

            • gabapentin

              gabapentin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • gemtuzumab

              deutetrabenazine and gemtuzumab both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • glasdegib

              deutetrabenazine and glasdegib both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • haloperidol

              haloperidol and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              haloperidol and deutetrabenazine both increase sedation. Use Caution/Monitor.

              haloperidol and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • hydromorphone

              hydromorphone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • hydroxyzine

              hydroxyzine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ibutilide

              ibutilide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • iloperidone

              iloperidone and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              iloperidone and deutetrabenazine both increase sedation. Use Caution/Monitor.

              iloperidone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • imipramine

              imipramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • inotuzumab

              inotuzumab and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • lacosamide

              lacosamide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • lamotrigine

              lamotrigine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • lasmiditan

              lasmiditan, deutetrabenazine. 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.

            • lemborexant

              lemborexant, deutetrabenazine. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

            • levetiracetam

              levetiracetam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • levorphanol

              levorphanol and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • lofexidine

              deutetrabenazine and lofexidine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • lopinavir

              lopinavir will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

              lopinavir and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • lorazepam

              lorazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • lorcaserin

              lorcaserin will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • loxapine

              loxapine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              loxapine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • loxapine inhaled

              loxapine inhaled and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              loxapine inhaled and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • lumefantrine

              lumefantrine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • lurasidone

              lurasidone and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              lurasidone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • meperidine

              meperidine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • methadone

              methadone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • methohexital

              methohexital and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • methsuximide

              methsuximide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • metoclopramide

              metoclopramide and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

            • midazolam

              midazolam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • midazolam intranasal

              midazolam intranasal, deutetrabenazine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

            • mifepristone

              mifepristone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • mirabegron

              mirabegron will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • morphine

              morphine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • moxifloxacin

              moxifloxacin and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • nalbuphine

              nalbuphine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • nilotinib

              nilotinib and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • nortriptyline

              nortriptyline and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • olanzapine

              olanzapine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              olanzapine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • osilodrostat

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

            • oxaliplatin

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

            • oxazepam

              oxazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • oxcarbazepine

              oxcarbazepine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • oxycodone

              oxycodone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • oxymorphone

              oxymorphone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ozanimod

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

            • paliperidone

              paliperidone and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              paliperidone and deutetrabenazine both increase sedation. Use Caution/Monitor.

              paliperidone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • paroxetine

              paroxetine will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • pentazocine

              pentazocine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • pentobarbital

              pentobarbital and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • perphenazine

              perphenazine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              perphenazine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • phenytoin

              phenytoin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • pimavanserin

              pimavanserin and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              pimavanserin and deutetrabenazine both increase sedation. Use Caution/Monitor.

              pimavanserin and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • pimozide

              pimozide and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              pimozide and deutetrabenazine both increase sedation. Use Caution/Monitor.

              pimozide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • pitolisant

              deutetrabenazine and pitolisant both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • pregabalin

              pregabalin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • procainamide

              procainamide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • prochlorperazine

              prochlorperazine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

            • promethazine

              promethazine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • protriptyline

              protriptyline and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • quazepam

              quazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • quetiapine

              quetiapine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              quetiapine and deutetrabenazine both increase sedation. Use Caution/Monitor.

              quetiapine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • quinidine

              quinidine will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

              quinidine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. Quinidine is a strong CYP2D6 inhibitor and also prolongs the QT interval. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • quinine

              quinine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • ramelteon

              ramelteon and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • remifentanil

              remifentanil and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • remimazolam

              remimazolam, deutetrabenazine. 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.

            • risperidone

              risperidone and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              risperidone and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • rolapitant

              rolapitant will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors. Rolapitant may increase plasma concentrations of CYP2D6 substrates for at least 28 days following rolapitant administration.

            • rufinamide

              rufinamide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • secobarbital

              secobarbital and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • selpercatinib

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

            • sotalol

              sotalol and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • sufentanil

              sufentanil and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • sufentanil SL

              sufentanil SL and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • suvorexant

              suvorexant and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • tapentadol

              tapentadol and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • tasimelteon

              tasimelteon and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • temazepam

              temazepam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • terbinafine

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

            • thioridazine

              thioridazine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              thioridazine and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

              thioridazine will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • thiothixene

              thiothixene and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              thiothixene and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • tiagabine

              tiagabine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • tipranavir

              tipranavir will increase the level or effect of deutetrabenazine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Strong CYP2D6 inhibitors increase the systemic exposure to the active dihydro-metabolites of deutetrabenazine by approximately 3-fold. Do not exceed 18 mg/dose and 36 mg/day of deutetrabenazine if coadministered with strong CYP2D6 inhibitors.

            • topiramate

              topiramate and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • toremifene

              toremifene and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • tramadol

              tramadol and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • triazolam

              triazolam and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • triclabendazole

              triclabendazole and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • trifluoperazine

              trifluoperazine and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              trifluoperazine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • trimipramine

              trimipramine and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • valproic acid

              valproic acid and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • vandetanib

              vandetanib and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • vemurafenib

              vemurafenib and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • vigabatrin

              vigabatrin and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • zaleplon

              zaleplon and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • ziprasidone

              ziprasidone and deutetrabenazine both increase antidopaminergic effects, including extrapyramidal symptoms and neuroleptic malignant syndrome. Modify Therapy/Monitor Closely. The risk for parkinsonism, neuroleptic malignant syndrome, and akathisia may be increased by concomitant use of deutetrabenazine and dopamine antagonists or antipsychotics.

              ziprasidone and deutetrabenazine both increase sedation. Use Caution/Monitor.

              ziprasidone and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • zolpidem

              zolpidem and deutetrabenazine both increase sedation. Use Caution/Monitor.

            • zonisamide

              zonisamide and deutetrabenazine both increase sedation. Use Caution/Monitor.

            Minor (2)

            • azithromycin

              azithromycin increases toxicity of deutetrabenazine by QTc interval. Minor/Significance Unknown.

            • chloroquine

              chloroquine increases toxicity of deutetrabenazine by QTc interval. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Somnolence (11%)

            1-10%

            Diarrhea (9%)

            Dry mouth (9%)

            Fatigue (9%)

            Urinary tract infection (7%)

            Insomnia (7%)

            Anxiety (4%)

            Constipation (4%)

            Contusion (4%)

            Dizziness (4%)

            Akathisia, agitation, or restlessness (4%)

            Depression in patients with Huntington’s disease (4%)

            Suicidal ideation in patients with Huntington’s disease (2%)

            Parkinsonism in patients with Huntington’s disease

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            Warnings

            Black Box Warnings

            Can increase risk for depression and suicidality in patients with Huntington disease; when prescribing, consider this risk with the clinical need for chorea treatment

            Closely monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior

            Inform patients, caregivers, and families of the risk of depression and suicidality; instruct them to report behaviors of concern promptly to the treating physician

            Particular caution is needed with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington disease

            Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression

            Contraindications

            Patients with Huntington disease who are suicidal, or in patients with untreated or inadequately treated depression

            Hepatic impairment

            Coadministration with MAOIs; deutetrabenazine should not be used in combination with an MAOI or within 14 days of discontinuing an MAOI

            Coadministration with reserpine; at least 20 days should elapse after stopping reserpine before initiating deutetrabenazine

            Coadministration with tetrabenazine or valbenazine

            Cautions

            Huntington disease is a progressive disorder characterized by changes in mood, cognition, chorea, rigidity, and functional capacity over time; VMAT2 inhibitors, including deutetrabenazine, may cause a worsening in mood, cognition, rigidity, and functional capacity; periodically reevaluate the need for deutetrabenazine by assessing effect on chorea and adverse effects

            Patients with Huntington disease are at increased risk for depression and suicidality; deutetrabenazine may increase this risk (see Black Box Warnings and Contraindications)

            May increase the risk of akathisia, agitation, and restlessness in patients with Huntington’s disease and tardive dyskinesia; reduce dose or discontinue if this occurs

            Sedation/somnolence reported; may impair patient’s ability to drive or operate complex machinery

            Drug may prolong QT interval, but the degree of QT prolongation is not clinically significant when drug is administered within recommended dosage range

            Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase (about 8 msec) in the corrected QT (QTc) interval; avoid in patients with congenital long QT syndrome or history of cardiac arrhythmias; for deutetrabenazine doses >24 mg/day in patients who are using other drugs known to prolong QTc, assess the QTc interval before and after increasing the deutetrabenazine dose or other medications that are known to prolong QTc

            Elevated serum prolactin levels may occur; tissue culture experiments indicate that approximately one third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if deutetrabenazine is being considered for a patient with previously detected breast cancer; if there is clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing, and discontinuation of therapy should be considered

            Deutetrabenazine and its metabolites bind to melanin-containing tissues and can accumulate in these tissues over time; ophthalmologic monitoring in humans was inadequate in clinical trials to exclude the possibility of injury after long-term exposure

            Neuroleptic malignant syndrome (NMS)

            • Reported with drugs that reduce dopaminergic transmission; while not observed with deutetrabenazine, it has been reported with tetrabenazine
            • Monitor for manifestations of NMS (eg, hyperpyrexia, muscle rigidity, altered mental status, autonomic instability, increased creatinine phosphokinase, myoglobinuria, rhabdomyolysis, acute renal failure)
            • Manage NMS by immediately discontinuing the drug and intensively treating symptoms and any concomitant serious medical problems; there is no general agreement about specific pharmacological treatment regimens for NMS
            • Recurrence of NMS has been reported with resumption of drug therapy; if treatment with drug needed after recovery from NMS, patients should be monitored for signs of recurrence;

            Parkinsonism

            • May cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia
            • Parkinsonism has been observed with other VMAT2 inhibitors
            • Difficult to distinguish between potential drug-induced parkinsonism and progression of underlying Huntington’s disease
            • Parkinsonism in patients treated with drug for tardive dyskinesia reported; symptoms have included bradykinesia, gait disturbances
            • In most cases, parkinsonism occurred within first two weeks after starting or increasing dose
            • Parkinsonism was reported to resolve following discontinuation of therapy
            • If parkinsonism develops during treatment, dose should be reduced; some patients may require discontinuation of therapy

            Drug interaction overview

            • Coadministration with dopamine antagonists or antipsychotics may increase risk for parkinsonism, NMS, and akathisia
            • Coadministration with alcohol and other sedating drugs may worsen somnolence associated with deutetrabenazine
            • Strong CYP2D6 inhibitors
              • Deutetrabenazine is extensively biotransformed to its major active dihydro-metabolites, alpha and beta-HTBZ, which are subsequently metabolized primarily by CYP2D6
              • Dose reduction of deutetrabenazine may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose
              • Systemic exposure of the active dihydro-metabolites is increased ~3-fold when coadministered with strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, bupropion)
              • Do not exceed 36 mg/day or a single dose of 18 mg if coadministered with a strong CYP2D6 inhibitor
            • QTc prolongation
              • Clinically relevant QT prolongation may occur in some patients treated with deutetrabenazine who are CYP2D6 poor metabolizers or are coadministered a strong CYP2D6 inhibitor; see above information (strong CYP2D6 inhibitors) for dose modifications/limitations
              • For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc
              • Assess other risks for QT prolongation; certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including bradycardia, hypokalemia, or hypomagnesemia; concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval
            • Contraindicated drug combinations
              • Coadministration with MAOIs is contraindicated; deutetrabenazine should not be used in combination with an MAOI or within 14 days of discontinuing an MAOI
              • Coadministration with reserpine is contraindicated; at least 20 days should elapse after stopping reserpine before initiating deutetrabenazine; reserpine binds irreversibly to VMAT2 and the duration of its effects is several days; wait for chorea to reemerge before administering deutetrabenazine to reduce risk of overdosage and major depletion of serotonin and norepinephrine in the CNS
              • Coadministration with tetrabenazine is contraindicated (see Dosing information on how to switch from tetrabenazine)
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate data on the developmental risk in pregnant women

            Animal studies

            • Administration of deutetrabenazine to rats during organogenesis produced no clear adverse effect on embryofetal development
            • However, administration of tetrabenazine to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offspring mortality

            Lactation

            Unknown if distributed in human breast milk

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

            Pregnancy Categories

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

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

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

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

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

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Oral vesicular monoamine transporter-2 (VMAT-2) inhibitor; decreases uptake of monoamines (eg, dopamine, serotonin, norepinephrine, histamine) into synaptic vesicles and depletes monoamine stores from nerve terminals

            The precise mechanism by which deutetrabenazine exerts its antichorea effects is unknown, but is believed to be related to its effect on reversible depletion of monoamines from nerve terminals

            Absorption

            Bioavailability: 80%

            Plasma concentrations of deutetrabenazine are generally below the limit of detection because of the extensive hepatic metabolism

            Peak plasma time (active metabolites): 3-4 hr

            Distribution

            Vd: 500 L (alpha-HTBZ); 730 L (beta-HTBZ)

            Binds to melanin-containing tissues (eg, skin, eyes)

            Following IV administration of tetrabenazine: Rapidly distributed to the brain, with the highest binding in the striatum and the lowest in the cortex

            Protein bound

            • Tetrabenazine: 82-85%
            • Alpha-HTBZ: 60-68%
            • Beta-HTBZ: 59-63%

            Metabolism

            Deutetrabenazine is extensively biotransformed, mainly by carbonyl reductase, to its major active metabolites alpha-HTBZ and beta­HTBZ, which are subsequently metabolized primarily by CYP2D6, with minor contributions of CYP1A2 and CYP3A4/5, to form several minor metabolites

            Elimination

            Half-life (active metabolites): 9-10 hr

            Clearance: 47 L/hr (alpha-HTBZ); 70 L/hr (beta-HTBZ)

            Excretion: 75-86% urine; 8-11% feces

            Pharmacogenomics

            CYP2D6 poor metabolizers

            • Although the pharmacokinetics of deutetrabenazine and its metabolites have not been systematically evaluated in patients who do not express the drug metabolizing enzyme, it is likely that the exposure to alpha and beta-HTBZ would be increased similarly to taking a strong CYP2D6 inhibitor (~3-fold)
            • Decrease deutetrabenazine dose if administered in CYP2D6 poor metabolizers
            • Also see Cautions and Dosage Modification
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            Administration

            Oral Administration

            Administer with food

            Swallow tablet whole; do not chew, crush, or break

            Discontinuing treatment: Can be discontinued without tapering

            Switching from tetrabenazine to deutetrabenazine

            • Discontinue tetrabenazine and initiate deutetrabenazine the following day
            • Recommended initial deutetrabenazine dose when switched from tetrabenazine
              • Tetrabenazine 12.5 mg/day: Initiate with deutetrabenazine 6 mg/day
              • Tetrabenazine 25 mg/day: Initiate with deutetrabenazine 6 mg/day
              • Tetrabenazine 37.5 mg/day: Initiate with deutetrabenazine 9 mg/day
              • Tetrabenazine 50 mg/day: Initiate with deutetrabenazine 12 mg/day
              • Tetrabenazine 62.5 mg/day: Initiate with deutetrabenazine 15 mg/day
              • Tetrabenazine 75 mg/day: Initiate with deutetrabenazine 18 mg/day
              • Tetrabenazine 87.5 mg/day: Initiate with deutetrabenazine 21 mg/day
              • Tetrabenazine 100 mg/day: Initiate with deutetrabenazine 24 mg/day

            Treatment interruption

            • ≥1 week: Must titrate dose when resumed (as with initial treatment)
            • <1 week: May resume at previous maintenance dose without titration

            Storage

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

            Protect from light and moisture

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Austedo oral
            -
            9 mg tablet
            Austedo oral
            -
            6 mg tablet
            Austedo oral
            -
            12 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Formulary

            FormularyPatient Discounts

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

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

            Adding plans allows you to:

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

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

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