DEUTETRABENAZINE

Class

• Vesicular monoamine transporter 2 (VMAT2) inhibitor

DEUTETRABENAZINE commonly prescribed for

(Bold for FDA approved)

How DEUTETRABENAZINE works

• Deutetrabenazine is a selective and reversible inhibitor of the vesicular monoamine transporter 2 (VMAT2), which packages monoamines, including dopamine, into synaptic vesicles of presynaptic neurons in the CNS

How long until DEUTETRABENAZINE works

• In clinical trials deutetrabenazine separated from placebo as early as weeks 2–4

Notable Side Effects

• Sedation, fatigue, dizziness, insomnia, nasopharyngitis

• Diarrhea, dry mouth

Life Threatening Side Effects

• QTc prolongation, although the degree of QTc prolongation is not clinically significant at concentrations expected with recommended dosing

• Neuroleptic malignant syndrome (has not been observed in patients taking deutetrabenazine, but it has been observed in patients taking tetrabenazine)

• Risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease

weight gain

unusual

sedation

common

What to do about DEUTETRABENAZINE side effects

• Wait

• Wait

• Wait

• Reduce dose or discontinue if agitation, akathisia, restlessness, or parkinsonism occurs

usual dosage range

• Tardive dyskinesia: 12–48 mg/day

• Chorea associated with Huntington’s disease: 6–48 mg/day

Dosage Forms

• Tablet 6 mg, 9 mg, 12 mg

• Extended-release tablet 6 mg, 12 mg, 24 mg

long term use

• Long-term clinical trials have not been conducted

habit forming

• No

Renal Impairment

• Not evaluated

Hepatic Impairment

• Contraindicated

Cardiac Impairment

• May cause an increase in QTc interval; avoid use in patients with congenital long QTc syndrome or with arrhythmias associated with a prolonged QTc interval

• For patients at risk for QTc prolongation: assess the QTc interval before and after increasing the total dosage above 24 mg/ day

Elderly

• Some patients may tolerate lower doses better

Children and Adolescents

• Safety and efficacy have not been established

Pregnancy

• Controlled studies have not been conducted in pregnant women

• In rat studies, no malformations were observed when deutetrabenazine was administered during the period of organogenesis at doses up to 6 times the maximum recommended human dose

• In rat studies, administration of tetrabenazine during organogenesis through lactation produced an increase in the number of stillborn pups and postnatal pup mortalities

Breast Feeding

• Unknown if deutetrabenazine is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk