REXULTI FILM-COATED TABLETS 0.25MG [SIN15768P]

Product Info

REXULTI FILM-COATED TABLETS 0.25MG

[SIN15768P]

4.1 THERAPEUTIC INDICATIONS
Brexpiprazole is indicated in adult patients for:

• Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was demonstrated in 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The long-term efficacy of brexpiprazole as adjunctive treatment in MDD has not been established.

• Treatment of schizophrenia (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) in adults and pediatric patients aged 13 years and older.

• Treatment of agitation associated with Alzheimer’s dementia (AAD), who are unresponsive to non-pharmacological interventions.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use once daily with or without food. REXULTI may only be administered as whole tablets.

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.

Treatment of Agitation Associated with Alzheimer’s Dementia

Prior to initiation and during REXULTI treatment, patients with AAD should be evaluated and appropriately treated, if applicable, for any reversible factors leading to agitation (e.g. pain, infection, polypharmacy, acute delirium) and should have been found unresponsive to non-pharmacological interventions.

The recommended starting dosage for Rexulti for the treatment of AAD is 0.5mg taken orally once daily on Days 1 to 7. The dosage should be titrated on Days 8 through 14 to 1mg, and on Day 15 to 2mg. The recommended target dose range is 2mg to 3mg once daily. After at least 28 days at 2mg once daily, the dose can be increased to the maximum recommended daily dose of 3mg, if clinically warranted. Assess efficacy after 12 weeks of treatment and periodically thereafter to determine the continued need for maintenance treatment and appropriate dosage. Discontinue treatment in case of unsatisfactory treatment response (See Clinical Studies section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

REXULTI should not be used as an ‘as needed’ treatment of agitation in AD.

Dosing Modifications for Hepatic Impairment
The maximum recommended dosage for patients with moderate to severe hepatic impairment (Child-Pugh score ≥7) is 2 mg once daily for patients with MDD or AAD, and 3 mg once daily for patients with schizophrenia.

Dosing Modifications for Renal Impairment
The maximum recommended dosage for patients with moderate, severe or end-stage renal impairment (creatinine clearance CrCl<60 mL/minute) is 2 mg once daily for patients with MDD or AAD and 3 mg once daily for patients with schizophrenia.

Non-pharmacological interventions should be tried before initiating treatment with REXULTI.

4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.