Remleas Dosage/Direction for Use

Posology: The initial dosage for REMLEAS is 40 mg once daily. After one week, increase the dose to the recommended dosage of 80 mg once daily. Continuation of 40 mg once daily may be considered for some patients.
Administer REMLEAS orally with or without food [see Pharmacology: Pharmacokinetics under Actions].
Special population: Pediatric Use: Safety and effectiveness of REMLEAS have not been established in pediatric patients.
Geriatric Use: No dose adjustment is required for elderly patients. In 3 randomized, placebo-controlled studies of REMLEAS, 16% were 65 years and older. The safety and effectiveness were similar in patients older than 65 years compared to younger patients.
CYP2D6 Poor Metabolizers: Dosage reduction of REMLEAS is recommended for known CYP2D6 poor metabolizers. The recommended dosage for known CYP2D6 poor metabolizers is REMLEAS 40 mg once daily. 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 [see Pharmacology: Pharmacokinetics under Actions].
Dose adjustments due to interactions: Coadministration with Strong CYP3A4 Inducers: Concomitant use of strong CYP3A4 inducers with REMLEAS is not recommended [see Interactions].
Coadministration with Strong CYP3A4 Inhibitors: The recommended dosage for patients receiving strong CYP3A4 inhibitors is REMLEAS 40 mg once daily [see Interactions].
Coadministration with Strong CYP2D6 Inhibitors: The recommended dosage for patients receiving strong CYP2D6 inhibitors is REMLEAS 40 mg once daily [see Interactions].
Hepatic Impairment: The recommended dosage for patients with moderate or severe hepatic impairment (Child-Pugh score 7 to 15) is REMLEAS 40 mg once daily. Patients with moderate to severe hepatic impairment had higher exposure of valbenazine and its active metabolite than patients with normal hepatic function [see Pharmacology: Pharmacokinetics under Actions].
Renal Impairment: Dosage adjustment is not necessary for patients with mild, moderate, or severe renal impairment. REMLEAS does not undergo primary renal clearance [see Pharmacology: Pharmacokinetics under Actions].