(Bold for FDA approved)
• 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
• In clinical trials valbenazine separated from placebo as early as week 2
• Sedation
• 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
unusual
common
• Wait
• Wait
• Wait
• Discontinue if NMS occurs
• Reduce dose or discontinue if agitation, akathisia, restlessness, or parkinsonism occurs
• 40–80 mg once daily
• Capsule 40 mg, 60 mg, 80 mg
• Clinical trials have shown continued improvement through 48 weeks
• No
• Mild to moderate impairment: dose adjustment not necessary
• Severe impairment: not recommended for use
• Moderate to severe impairment: 40 mg once daily
• 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
• Dose adjustment not necessary
• Safety and efficacy have not been established
• 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
• 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
Based on data Published online by Cambridge University Press
Compiled by Dr. Jash Ajmera