SYMVENU HARD CAPSULES 4.5MG [SIN15745P]

Product Info

SYMVENU HARD CAPSULES 4.5MG

[SIN15745P]

3.1 Therapeutic indications

Symvenu® is indicated for

• treatment of schizophrenia in adult patients,

• acute treatment of manic or mixed episodes associated with bipolar I disorder in adult patients,

• treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients.

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).

3.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Concomitant administration of strong or moderate CYP3A4 inhibitors (see section 3.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Concomitant administration of strong or moderate CYP3A4 inducers (see section 3.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).