REXULTI FILM-COATED TABLETS 0.5MG

LUNDBECK SINGAPORE PTE. LTD.

LUNDBECK SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 POSOLOGY AND METHOD OF ADMINISTRATION** For oral use once daily with or without food **Adjunctive treatment of Major Depressive Disorder (Adults)** The recommended starting dose for brexpiprazole as adjunctive treatment of MDD in adults is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials. The benefit of the 3 mg dose has not been clearly established (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Periodically reassess to determine the continued need and appropriate dose for treatment. The long-term efficacy of brexpiprazole as adjunctive treatment in MDD has not been established. **Schizophrenia (Adults and Pediatric Patients 13 to 17 Years)** **Adults** The recommended starting dose for brexpiprazole in the treatment of adult patients with schizophrenia is 1 mg once daily on days 1 to 4. The recommended target dose range is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient’s clinical response and tolerability. The maximum recommended daily dosage is 4 mg. _Maintenance treatment:_ The recommended maintenance dose range is 2 mg/day to 4 mg/day. Periodically reassess to determine the continued need for maintenance treatment. **Pediatric Patients (13 to 17 years of age)** The recommended starting dosage for REXULTI for the treatment of schizophrenia in pediatric patients 13 to 17 years of age is 0.5 mg once daily on Days 1 to 4, taken orally with or without food _\[see Special Population (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. Titrate to 1 mg once daily on Day 5 through Day 7, then to 2 mg on Day 8 based on the patient’s clinical response and tolerability. Weekly dose increases can be made in 1 mg increments. The recommended target REXULTI dosage is 2 mg to 4 mg once daily. The maximum recommended daily dosage is 4 mg. **Dosing Adjustment for Hepatic Impairment** For patients with moderate to severe hepatic impairment (Child-Pugh score ≥7), the maximum recommended dosage is 2 mg once daily for patients with MDD, and 3 mg once daily for patients with schizophrenia. **Dosing Adjustment for Renal Impairment** For patients with moderate, severe or end-stage renal impairment (creatinine clearance CrCl<60 mL/minute), the maximum recommended dosage is 2 mg once daily for patients with MDD and 3 mg once daily for patients with schizophrenia.