Cariprazine

DEA Class;  Rx

Common Brand Names; Vraylar

Hypersensitivity to cariprazine

Schizophrenia

• Extrapyramidal symptoms, all (24-33%)

• Extrapyramidal symptoms, excluding akathisia/restlessness (15-20%)

• Parkinsonism (13-18%)

• Headache (9-18%)

• Akathisia (9-14%)

• Insomnia (11-13%)

Bipolar mania

• Extrapyramidal symptoms, all (41-45%)

• Extrapyramidal symptoms, excluding akathisia/restlessness (26-29%)

• Parkinsonism (21-26%)

• Akathisia (20-21%)

• Headache (13-14%)

• Nausea (11-13%)

• Constipation (6-11%)

Bipolar depression

• Extrapyramidal symptoms, all (10-19%)

Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis; a higher incidence of stroke and TIA, including fatal stroke, was also observed (see Black Box Warnings)

Hypersensitivity reactions reported ranging fom rash, pruritus, urticaria, and events suggestive of angioedema (eg, swollen, tongue, lip swelling, face edema, pharyngeal edema, facial swelling)

Neuroleptic malignant syndrome reported; monitor for hyperpyrexia, muscle rigidity, delirium, and autonomic instability; other signs include increased CPK, myoglobinuria (rhabdomyolysis), and acute renal failure; if NMS is suspected, immediately discontinue treatment

Tardive dyskinesia, a potentially irreversible, involuntary, dyskinetic movement syndrome, may develop in patients treated with antipsychotics

Adverse effects may first appear several weeks after initiating treatment, as drug and metabolite levels accumulate; monitor for extrapyramidal symptoms or akathisia

Leukopenia and neutropenia reported; agranulocytosis (including fatal cases) reported with other atypical antipsychotics; discontinue cariprazine in patients with absolute neutrophil count <1000/mm³ and follow WBC until recovery

May cause orthostatic hypotension and syncope; caution in patients vulnerable to hypotension (eg, elderly, dehydration, hypovolemia, concomitant antihypertensive drugs, cardiovascular or cerebrovascular disease)

May cause seizures; risk is greatest with history of seizures or conditions that lower seizure threshold

May cause cognitive and motor impairment

Body temperature dysregulation reported; may disrupt ability to reduce core body temperature; caution with strenuous exercise, exposure to extreme heat, dehydration, and coadministration with anticholinergic medications

Esophageal dysmotility and aspiration reported with antipsychotic drug use

Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal symptoms or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization

Unknown if distributed in human breast milk

Present in rat milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition