REMLEAS HARD CAPSULES 40 MG [SIN16198P]

Product Info

REMLEAS HARD CAPSULES 40 MG

[SIN16198P]

4.1 Therapeutic indications

REMLEAS is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.

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 (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 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].

4.3 Contraindications

REMLEAS is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of REMLEAS. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported. [see Undesirable effects (4.8.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].