VALBENAZINE

brands

Class

• Vesicular monoamine transporter 2 (VMAT2) inhibitor

VALBENAZINE commonly prescribed for

(Bold for FDA approved)

How VALBENAZINE works

• Valbenazine 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 VALBENAZINE works

• In clinical trials valbenazine separated from placebo as early as week 2

Notable Side Effects

• Sedation

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 (NMS)

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

weight gain

unusual

sedation

common

What to do about VALBENAZINE side effects

• Wait

• Wait

• Wait

• Discontinue if NMS occurs

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

usual dosage range

• 40–80 mg once daily

Dosage Forms

• Capsule 40 mg, 60 mg, 80 mg

long term use

• Clinical trials have shown continued improvement through 48 weeks

habit forming

• No

Renal Impairment

• Mild to moderate impairment: dose adjustment not necessary

• Severe impairment: not recommended for use

Hepatic Impairment

• Moderate to severe impairment: 40 mg once daily

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

Elderly

• Dose adjustment not necessary

Children and Adolescents

• Safety and efficacy have not been established

Pregnancy

• Controlled studies have not been conducted in pregnant women

• In animal studies, no malformations were observed when valbenazine was administered during the period of organogenesis at doses up to 1.8 (rat) or 24 (rabbit) times the maximum recommended human dose (MRHD)

• In rat studies, administration during organogenesis through lactation produced an increase in the number of stillborn pups and postnatal pup mortalities at doses less than the MHRD

Breast Feeding

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

• Breastfeeding is not recommended, including for 5 days after the final dose