taillights [1:<1 times the MRHD of 80 mg/day based on mg/m 2 (because of death in the majority of the high dose group [1.2 times the MRHD], these parameters were not assessed in this group). 1 Lactation There is no information regarding the presence of valbenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Valbenazine and its metabolites have been detected in rat milk at concentrations higher than in plasma following oral administration of valbenazine at doses 0.1 to 1.2 times the MRHD based on mg/m 2 . Based on animal findings of increased perinatal mortality in exposed fetuses and pups, advise a woman not to breastfeed during treatment with valbenazine tosylate and for 5 days after the final dose. 1 Pediatric Use Safety and effectiveness of valbenazine tosylate have not been established in pediatric patients. 1 Geriatric Use No dose adjustment is required for elderly patients. In 3 randomized, placebo-controlled studies of valbenazine tosylate, 16% were 65 years and older. The safety and effectiveness were similar in patients older than 65 years compared to younger patients. 1 CYP2D6 Poor Metabolizers Consider reducing valbenazine tosylate dose based on tolerability for known CYP2D6 poor metabolizers. Increased exposure (C max and AUC) to valbenazine s active metabolite is anticipated in CYP2D6 poor metabolizers. Increased exposure of active metabolite may increase the risk of exposure-related adverse reactions. 1 Hepatic Impairment Dosage reduction of valbenazine tosylate is recommended for patients with moderate or severe hepatic impairment. Patients with moderate to severe hepatic impairment (Child-Pugh score 7 to 15) had higher exposure of valbenazine and its active metabolite than patients with normal hepatic function. 1 Renal Impairment Dosage adjustment is not necessary for patients with mild to moderate renal impairment (creatinine clearance 30 to 90 mL/min). Valbenazine tosylate does not undergo primary renal clearance. Valbenazine tosylate is not recommended in patients with severe renal impairment (creatinine clearance> <30 mL/min). 1 Common Adverse Effects Most common adverse reaction ( 5% and twice the rate of placebo): somnolence. 1 Drug Interactions Specific Drugs It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights: Dose adjustments due to drug interactions: Concomitant Drugs Dose Adjustments for Valbenazine Tosylate MAOIs Avoid concomitant use 1 Strong CYP3A4 inducers Concomitant use not recommended 1 Strong CYP3A4 inhibitors Reduce valbenazine dose to 40 mg 1 Strong CYP2D6 inhibitors Consider valbenazine dose reduction based on tolerability 1 Actions Mechanism of Action The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release. 1 Advice to Patients Patient Counseling Information Advise the patient to read the FDA-approved patient labeling. 1 Inform patients that valbenazine tosylate may cause somnolence and may impair the ability to perform tasks that require complex motor and mental skills. Advise patients that until they learn how they respond to valbenazine tosylate, they should be careful or avoid doing activities that require them to be alert, such as driving a car or operating machinery. 1 Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations. Advise patients to inform physicians that they are taking valbenazine tosylate before any new drug is taken. 1 Advise a pregnant patient of the potential risk to a fetus. 1 Advise a woman not to breastfeed during treatment with valbenazine tosylate and for 5 days after the final dose. 1 Additional Information AHFS First Release . For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Valbenazine Tosylate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Capsule 40 mg (of valbenazine) Ingrezza Neurocrine Biosciences Inc. AHFS Drug Information. Copyright 2017, Selected Revisions October 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Neurocrine Biosciences, Inc. INGREZZA (Valbenazine) ORAL prescribing information. San Diego, CA; 2017 Apr. Next Interactions Print this page Add to My Med List More about valbenazine Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: VMAT2 inhibitors Consumer resources Valbenazine Professional resources Other brands: Ingrezza Related treatment guides Tardive Dyskinesia> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class VMAT2 inhibitors Related Drugs Tardive Dyskinesia vitamin e , Ingrezza , Austedo , Alpha E , valbenazine , deutetrabenazine , E-400 Clear , Aquasol E , More... Valbenazine Rating No Reviews - Be the first! 10 /10 No Reviews - Be the first! 10 Rate it! kit
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