REMLEAS HARD CAPSULES 40 MG

CAPSULE, GELATIN COATED

**4.2 Posology and method of administration** 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 _\[see Pharmacokinetic properties (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. 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 (Cmax 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 _\[see Pharmacokinetic properties (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. _Dose adjustments due to interactions_ Coadministration with Strong CYP3A4 Inducers Concomitant use of strong CYP3A4 inducers with REMLEAS is not recommended _\[see Interactions with other medicinal products and other forms of interaction (4.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Coadministration with Strong CYP3A4 Inhibitors The recommended dosage for patients receiving strong CYP3A4 inhibitors is REMLEAS 40 mg once daily _\[see Interactions with other medicinal products and other forms of interaction (4.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Coadministration with Strong CYP2D6 Inhibitors The recommended dosage for patients receiving strong CYP2D6 inhibitors is REMLEAS 40 mg once daily _\[see Interactions with other medicinal products and other forms of interaction (4.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. _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 _\[see Pharmacokinetic properties (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. _Renal Impairment_ Dosage adjustment is not necessary for patients with mild, moderate, or severe renal impairment. REMLEAS does not undergo primary renal clearance _\[see Pharmacokinetic properties (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.