Indications
Valbenazine Tosylate is indicated for the treatment of adults with Tardive Dyskinesia.
Composition
Pharmacology
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 noradrenaline, dopamine, and serotonin in synaptic vesicles making them vulnerable to metabolism by cytosolic enzymes. The presynaptic release of monoamine neurotransmitters is decreased due to the lack of vesicles with packaged neurotransmitters ready for release into the synapse. Neither valbenazine nor its active metabolite exhibits significant off-target binding at dopamine, serotonin, or adrenaline receptors.
Dosage & Administration
The initial dose is 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily. Continuation of 40 mg once daily may be considered for some patients. Administer it orally with or without food.
Contraindications
Side Effects
Somnolence, QT Prolongation
Pregnancy & Lactation
The limited available data on Valbenazine use in pregnant women are insufficient to inform a drug-associated risk. A woman should not breastfeed during treatment with valbenazine and for 5 days after the final dose.
Precautions & Warnings
Valbenazine can cause somnolence. May impair the patient's ability to drive or operate hazardous machinery. Valbenazine may prolong the QT interval. For patients who are CYP2D6-poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. No dosage adjustment is necessary for patients with mild to moderate renal impairment. Use is not recommended in patients with severe renal impairment.
Therapeutic Class
Storage Conditions
Store below 25°C, in a cool & dry place. Keep away from light. Keep all the medicines out of the reach of children.