Cariprazinedosage

2. DOSAGE AND ADMINISTRATION Administer VRAYLAR orally once daily with or without food Starting Dose Recommended Dose Schizophrenia in Adults 1.5 mg daily 1.5 mg to 6 mg daily Schizophrenia in Pediatric Patients (13-17 years) 0.5 mg daily 1.5 mg to 4.5 mg daily Bipolar Mania in Adults 1.5 mg daily 3 mg to 6 mg daily Bipolar Mania in Pediatric Patients (10-17 years) 0.5 mg daily 3 mg or 4.5 mg daily Bipolar Depression in Adults 1.5 mg daily 1.5 mg or 3 mg daily Adjunctive therapy to antidepressants for MDD in Adults 1.5 mg daily 1.5 mg or 3 mg daily Adults with Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 6 mg. Dosages above 6 mg daily do not confer significant benefit, but increase the risk of dose-related adverse reactions Pediatric patients with Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 4.5 mg.

Adults with Bipolar Depression: Maximum recommended daily dosage is 3 mg Adjunctive therapy for treatment of MDD in Adults: Maximum recommended daily dosage is 3 mg

2.1 General

Dosing Information VRAYLAR is given orally once daily and can be taken with or without food. 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. Prescribers should monitor patients for adverse reactions and treatment response for several weeks after starting VRAYLAR and after each dosage change.

2.2 Recommended

Dosage in Schizophrenia Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. The recommended dosage range is 1.5 mg to 6 mg orally once daily. The dosage can 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 orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. Pediatric Patients (13 to 17 years of age) The starting dosage of VRAYLAR is 0.5 mg orally once daily. The recommended dosage range is 1.5 mg to 4.5 mg orally once daily. Increase the dosage to 1.5 mg orally once daily on Day 3. Depending upon clinical response and tolerability, the dosage may be increased to 3 mg orally once daily starting on Day 5, and to 4.5 mg orally once daily starting on Day 8. The maximum recommended dosage is 4.5 mg orally once daily.

2.3 Recommended

Dosage in Manic or M ixed E pisodes Associated with Bipolar I Disorder Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. Increase the dosage to 3 mg orally once daily on Day 2. The recommended dosage range is 3 mg to 6 mg orally once daily. 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 orally once daily. In short-term controlled trials, dosages above 6 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. Pediatric Patients (10 to 17 years of age)​ The starting dosage of VRAYLAR is 0.5 mg orally once daily. The recommended dosage is 3 mg or 4.5 mg orally once daily. Increase the dosage to 1.5 mg orally once daily on Day 3 and to 3 mg orally once daily on Day 5. Depending upon clinical response and tolerability, the dosage may be increased to 4.5 mg orally once daily starting on Day 8. The maximum recommended dosage is 4.5 mg orally once daily.

2.4 Recommended

Dosage in Depressive Episodes Associated with Bipolar I Disorder (Bipolar Depression) in Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg orally once daily on Day 15. Maximum recommended dosage is 3 mg orally once daily.

2.5 Recommended

Dosage for Adjunctive Therapy to Antidepressants for the Treatment of Major Depressive Disorder in Adult Patients The starting dosage of VRAYLAR is 1.5 mg orally once daily. Depending upon clinical response and tolerability, the dosage can be increased to 3 mg orally once daily on Day 15. In clinical trials, dosage titration at intervals of less than 14 days resulted in a higher incidence of adverse reactions. Maximum recommended dosage is 3 mg orally once daily. 2. 6 Dosage Modifications for CYP3A4 Inhibitors and Inducers Initiating VRAYLAR While Taking a Strong or Moderate CYP3A4 Inhibitor Dosage modifications for the starting dosage of VRAYLAR in adult patients taking a strong or moderate CYP3A4 inhibitor are presented in Table 1: Table 1: Dosage Modifications for the Starting Dosage of VRAYLAR in Adult Patients Taking a Strong or Moderate CYP3A4 Inhibitor Adult Patients VRAYLAR Starting Dosage When Taking a Strong CYP3A4 Inhibitor When Taking a Moderate CYP3A4 Inhibitor Schizophrenia Start at 0.5 mg orally once daily; increase to 0.75 mg orally once daily, if needed* Start at 0.75 mg orally once daily; increase to 1.5 mg orally daily, if needed* Bipolar Mania Bipolar Depression 0.5 mg orally once daily 0.75 mg orally once daily Adjunctive therapy for treatment of MDD *Depending upon clinical response and tolerability. Initiating VRAYLAR is not recommended in pediatric patients while taking a strong or moderate CYP3A4 Inhibitor. Initiating a Strong or Moderate CYP3A4 Inhibitor While Taking a Stable Dosage of VRAYLAR Dosage recommendations for adult and pediatric patients initiating a strong or moderate CYP3A4 inhibitor while on a stable dose of VRAYLAR (see Table 2): Table 2: Dosage Modifications for VRAYLAR When Initiating a Strong or Moderate CYP3A4 Inhibitor and While Taking a Stable Dos ag e of VRAYLAR in Adult and Pediatric Patients Currently on VRAYLAR Dosage VRAYLAR Dosage When Initiating a Strong CYP3A4 Inhibitor VRAYLAR Dosage When Initiating a Moderate CYP3A4 Inhibitor 1.5 mg or 3 mg once daily 0.5 mg orally once daily 0.75 mg orally once daily 4.5 mg or 6 mg once daily 0.75 mg orally once daily 1.5 mg orally once daily When the strong or moderate CYP3A4 inhibitor is discontinued, the VRAYLAR dosage may need to be increased based on clinical response and tolerability. Dosage Modifications for Patients Concomitantly Taking VRAYLAR with CYP3A4 Inducers Concomitant use of VRAYLAR and a CYP3A4 inducer has not been evaluated and is not recommended. 2. 7 Treatment Discontinuation Following discontinuation of VRAYLAR, the decline in plasma concentrations of active drug and metabolites may not be immediately reflected in patients’ clinical symptoms; the plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week. There are no systematically collected data to specifically address switching patients from VRAYLAR to other antipsychotics or concerning concomitant administration with other antipsychotics.