SYMVENU HARD CAPSULES 3MG

MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.

MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

CAPSULE, GELATIN COATED

**3.2 Posology and method of administration** Posology _Schizophrenia_ The recommended starting dose of cariprazine is 1.5 mg once daily. Thereafter the dose can be increased slowly in 1.5 mg increments to a maximum dose of 6 mg/day, if needed. The lowest effective dose should be maintained according to the clinical judgement of the treating physician. Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Patients should be monitored for adverse reactions and treatment response for several weeks after starting cariprazine and after each dosage change (see section 4.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Manic or Mixed Episodes Associated with Bipolar I Disorder_ The recommended dose range is 3 mg to 6 mg once daily. The starting dose of cariprazine is 1.5 mg and should be increased to 3 mg on Day 2. Depending upon clinical response and tolerability, further dose adjustments can be made in 1.5 mg or 3 mg increments. The maximum recommended dosage is 6 mg daily. In short-term controlled studies, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. _Depressive episodes associated with Bipolar I Disorder (Bipolar Depression)_ The starting dose of cariprazine is 1.5 mg once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg once daily on Day 15. Maximum recommended dosage is 3 mg once daily. _Switching from other antipsychotics to cariprazine_ When switching from another antipsychotic to cariprazine gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while cariprazine treatment is initiated. _Switching to another antipsychotic from cariprazine_ When switching to another antipsychotic from cariprazine, no gradual cross-titration is needed, the new antipsychotic should be initiated in its lowest dose while cariprazine is discontinued. It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week (see section 4.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Missed dose_ If the patient misses a dose, the patient should take the missed dose as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose should be taken according to the regular schedule. It is not recommended to take a double dose to make up for the forgotten dose. Special population _Renal impairment_ No dose adjustment is required in patients with mild to moderate renal impairment (Creatinine Clearance (CrCl) ≥ 30 mL/min and < 89 mL/min). Safety and efficacy of cariprazine have not been evaluated in patients with severe renal impairment (CrCl < 30 mL/min). Use of cariprazine is not recommended in patients with severe renal impairment (see section 4.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5–9). Safety and efficacy of cariprazine have not been evaluated in patients with severe hepatic impairment (Child-Pugh score between 10 and 15). Use of cariprazine is not recommended in patients with severe hepatic impairment (see section 4.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Elderly_ Available data in elderly patients aged ≥65 years treated with cariprazine are not sufficient to determine whether or not they respond differently from younger patients (see section 4.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Dose selection for an elderly patient should be more cautious. _Paediatric population_ The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established. No data are available. Method of administration Symvenu® is for oral use, to be taken once daily at the same time of the day with or without food. Alcohol should be avoided when taking cariprazine (see section 3.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).