REMLEAS HARD CAPSULES 40 MG

Patheon France S.A.S (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: May 19, 2021
Approval ID: fb6882dbe5f44bf4
Company: Patheon France S.A.S (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: fb6882dbe5f44bf4
Drug Name: REMLEAS HARD CAPSULES 40 MG
Product Name: REMLEAS HARD CAPSULES 40 MG
Approval Number: SIN16198P
Approval Date: 2021-05-19
Registrant: TANABE PHARMA SINGAPORE PTE. LTD.
Licence Holder: MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: CAPSULE, GELATIN COATED
Dosage: 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].
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications REMLEAS is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.
Contraindications: 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].
Atc Code: N07XX13
Atc Item Name: valbenazine
Pharma Manufacturer Name: MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.

Active Ingredients

Valbenazine ditosylate eqv Valbenazine

40mg

VALBENAZINE DITOSYLATE EQV VALBENAZINE

40 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 19, 2021

Approval ID

fb6882dbe5f44bf4

Type

Therapeutic

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