INDICATION AND USES:
VRAYLAR is an atypical antipsychotic indicated for the:
- Treatment of schizophrenia in adults (1)
- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults (1)
- Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults (1)
- Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
DOSAGE AND ADMINISTRATION
Administer VRAYLAR once daily with or without food (2)
| Starting Dose | Recommended Dose | |
| Schizophrenia (2.2) | 1.5 mg daily | 1.5 mg to 6 mg daily |
| Bipolar Mania (2.3) | 1.5 mg daily | 3 mg to 6 mg daily |
| Bipolar Depression (2.4) | 1.5 mg daily | 1.5 mg or 3 mg daily |
- Schizophrenia and Bipolar Mania: Dosages above 6 mg daily do not confer significant benefit but increase the risk of dose-related adverse reactions (2.2, 2.3)
- Bipolar Depression: The maximum recommended daily dosage is 3 mg (2.4)
SIDE EFFECTS:
Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) were (6.1):
- Schizophrenia: extrapyramidal symptoms and akathisia
- Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness
- Bipolar depression: nausea, akathisia, restlessness, and extrapyramidal symptoms
CONTRAINDICATIONS:
Known hypersensitivity to VRAYLAR (4)
WARNINGS AND PRECAUTIONS:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) (5.3)
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.4)
- Tardive Dyskinesia: Discontinue if appropriate (5.5)
- Late-Occurring Adverse Reactions: Because of VRAYLAR’s long halflife, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change (5.6)
- Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain (5.7)
- Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia. Consider discontinuing VRAYLAR if a clinically significant decline in WBC occurs in absence of other causative factors (5.8)
- Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope (5.9)
- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold (5.11)
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery (5.12)
DRUG INTERACTIONS:
- Strong CYP3A4 inhibitors: Reduce VRAYLAR dosage by half (2.5, 7.1)
- CYP3A4 inducers: Concomitant use is not recommended (2.5, 7.1)
OVERDOSE:
In pre-marketing clinical trials involving VRAYLAR in approximately 5000 patients or healthy subjects, accidental acute overdosage (48 mg/day) was reported in one patient. This patient experienced orthostasis and sedation. The patient fully recovered the same day.
Management of Overdosage: No specific antidotes for VRAYLAR are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.
- Uses
-
INDICATION AND USES:
VRAYLAR is an atypical antipsychotic indicated for the:
- Treatment of schizophrenia in adults (1)
- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults (1)
- Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults (1)
- Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
DOSAGE AND ADMINISTRATION
Administer VRAYLAR once daily with or without food (2)
Starting Dose Recommended Dose Schizophrenia (2.2) 1.5 mg daily 1.5 mg to 6 mg daily Bipolar Mania (2.3) 1.5 mg daily 3 mg to 6 mg daily Bipolar Depression (2.4) 1.5 mg daily 1.5 mg or 3 mg daily - Schizophrenia and Bipolar Mania: Dosages above 6 mg daily do not confer significant benefit but increase the risk of dose-related adverse reactions (2.2, 2.3)
- Bipolar Depression: The maximum recommended daily dosage is 3 mg (2.4)
- Side Effects
-
SIDE EFFECTS:
Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) were (6.1):
- Schizophrenia: extrapyramidal symptoms and akathisia
- Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness
- Bipolar depression: nausea, akathisia, restlessness, and extrapyramidal symptoms
- Precautions
-
CONTRAINDICATIONS:
Known hypersensitivity to VRAYLAR (4)
WARNINGS AND PRECAUTIONS:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) (5.3)
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.4)
- Tardive Dyskinesia: Discontinue if appropriate (5.5)
- Late-Occurring Adverse Reactions: Because of VRAYLAR’s long halflife, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change (5.6)
- Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain (5.7)
- Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell counts (WBC) or history of leukopenia or neutropenia. Consider discontinuing VRAYLAR if a clinically significant decline in WBC occurs in absence of other causative factors (5.8)
- Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope (5.9)
- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold (5.11)
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery (5.12)
- Interactions
-
DRUG INTERACTIONS:
- Strong CYP3A4 inhibitors: Reduce VRAYLAR dosage by half (2.5, 7.1)
- CYP3A4 inducers: Concomitant use is not recommended (2.5, 7.1)
- Overdose
-
OVERDOSE:
In pre-marketing clinical trials involving VRAYLAR in approximately 5000 patients or healthy subjects, accidental acute overdosage (48 mg/day) was reported in one patient. This patient experienced orthostasis and sedation. The patient fully recovered the same day.
Management of Overdosage: No specific antidotes for VRAYLAR are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice.