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Medications: Vraylar ® – cariprazine

MEDICATIONS

Vraylar® – cariprazine (View the FDA label)

VRAYLAR is an atypical antipsychotic indicated for the:

  • Treatment of schizophrenia (1)
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder (1)

Most common adverse reactions (incidence > 5% and at least twice the rate of placebo) were (6.1):

  • Schozophrenia: extrapyramidal symptoms and akathisia
  • Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. (5.1)

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased evidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) (5.2).

Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.3).

Tardive Dyskinesia: Discontinue if appropriate (5.4).

Late-Occurring Adverse Reactions: Because of VRAYLAR’s long half-life, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change (5.5).

Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain (5.6).

Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope (5.8).

Strong CYP3A4 inhibitors: reduce VRAYLAR dosage by half (2.4, 7.1).

CYP3A4 inducers: do not recommend use with VRAYLAR (2.4, 7.1).

10.1 Human Experience
In pre-marketing clinical trials involving VRAYLAR in approximately 5,000 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.

10.2 Management of Overdose
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

VRAYLAR is an atypical antipsychotic indicated for the:

  • Treatment of schizophrenia (1)
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder (1)
Side Effects

Most common adverse reactions (incidence > 5% and at least twice the rate of placebo) were (6.1):

  • Schozophrenia: extrapyramidal symptoms and akathisia
  • Bipolar mania: extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness
Precautions

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. (5.1)

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased evidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) (5.2).

Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring (5.3).

Tardive Dyskinesia: Discontinue if appropriate (5.4).

Late-Occurring Adverse Reactions: Because of VRAYLAR’s long half-life, monitor for adverse reactions and patient response for several weeks after starting VRAYLAR and with each dosage change (5.5).

Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain (5.6).

Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope (5.8).

Interactions

Strong CYP3A4 inhibitors: reduce VRAYLAR dosage by half (2.4, 7.1).

CYP3A4 inducers: do not recommend use with VRAYLAR (2.4, 7.1).

Overdose

10.1 Human Experience
In pre-marketing clinical trials involving VRAYLAR in approximately 5,000 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.

10.2 Management of Overdose
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.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

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