Generic
Valbenazine Tosylate
1 brands available in the market
At a glance
Valbenazine Tosylate is indicated for the treatment of adults with Tardive Dyskinesia.
Description
Valbenazine and its active metabolites bind to and inhibit vesicular monoamine transporter 2 (VMAT2) with high selectivity with no significant binding to VMAT1. This prevents the reuptake and storage of monoamine neurotransmitters in synaptic vesicles.
Indications
- Tardive Dyskinesia
Therapeutic class
Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Pharmacological class
VMAT2 Inhibitor
Pharmacology
Valbenazine and its active metabolites bind to and inhibit VMAT2 with high selectivity with no significant binding to VMAT1. This prevents the reuptake and storage of monoamine neurotransmitters noradrenaline, dopamine, and serotonin in synaptic vesicles.
Mechanism of action
Inhibits VMAT2, decreasing presynaptic release of monoamine neurotransmitters.
Dosage
Adult Dose (Oral):
- Initial dose: 40 mg once daily
- After one week: increase to 80 mg once daily
- Continuation of 40 mg once daily may be considered for some patients
- Administer with or without food
Administration
- May be taken with or without food
- Swallow tablets whole
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Somnolence
- QT Prolongation
Precautions & warnings
- Can cause somnolence; may impair ability to drive or operate hazardous machinery
- May prolong QT interval; avoid in patients with congenital long QT syndrome or arrhythmias associated with prolonged QT interval
- Dose reduction may be necessary for CYP2D6-poor metabolizers or patients taking strong CYP2D6 inhibitors
- No dosage adjustment for mild to moderate renal impairment; not recommended in severe renal impairment
Contraindications
- Hypersensitivity to Valbenazine Tosylate
- Congenital long QT syndrome
- Arrhythmias associated with prolonged QT interval
Drug interactions
- MAOIs: increased risk of serotonin syndrome or attenuated treatment effect; avoid concomitant use
- Strong CYP3A4 inhibitors: increased exposure to valbenazine and its active metabolite; reduce dose
- Strong CYP2D6 inhibitors: consider reducing dose based on tolerability
- Strong CYP3A4 inducers: not recommended
- Digoxin: monitor concentrations; increased digoxin exposure may increase risk of adverse reactions
Food interactions
Food interactions are not significant.
Use in pregnancy
Use in Pregnancy: Limited available data; insufficient to inform a drug-associated risk.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Do not breastfeed during treatment and for 5 days after final dose.
Pediatric use
Safety and efficacy not established in children
Geriatric use
Caution required in elderly patients
Renal / hepatic impairment
Renal Impairment: Mild to moderate: no dosage adjustment; severe: not recommended
Hepatic Impairment: Limited information
Overdose effects
Symptoms: No information from clinical trials regarding overdose symptoms.
Treatment: No specific antidotes; provide supportive care, close medical supervision and monitoring.
Storage conditions
Store below 25°C, in a cool & dry place. Keep away from light. Keep all medicines out of reach of children.