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Vraylar
cariprazine
Black Box Warnings .
Dementia-Related Psychosis
not approved for dementia-related psychosis; incr. mortality risk in elderly patients on antipsychotic tx for dementia-related psychosis; most deaths due to cardiovascular or infectious events
Suicidality
incr. suicidality risk in peds and young adult patients in short-term studies; observe all antidepressant-treated patients for clinical worsening, suicidality, or unusual behavior changes; advise families and caregivers of need for close observation and communication with prescriber; safety and efficacy not established in peds patients
Adult Dosing .
Dosage forms: CAP: 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, 6 mg; CAP (schizophrenia or manic/mixed bipolar disorder 7-day starter pack): 1.5 mg x1 and 3 mg x6
schizophrenia
- [1.5-6 mg PO qd]
- Start: 1.5 mg PO qd x1 day, then may incr. to 3 mg PO qd; Max: 6 mg/day; Info: may adjust dose in 1.5 mg or 3 mg increments; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, manic/mixed
- [3-6 mg PO qd]
- Start: 1.5 mg PO qd x1 day, then incr. to 3 mg PO qd; Max: 6 mg/day; Info: may adjust dose in 1.5 mg or 3 mg increments; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, depressive
- [1.5-3 mg PO qd]
- Start: 1.5 mg PO qd x14 days, then may incr. to 3 mg PO qd; Max: 3 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
major depressive disorder, adjunct tx
- [1.5-3 mg PO qd]
- Start: 1.5 mg PO qd x14 days, then may incr. to 3 mg PO qd; Max: 3 mg/day; Info: use with antidepressant; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: CAP: 0.5 mg, 0.75 mg, 1.5 mg, 3 mg, 4.5 mg, 6 mg; CAP (schizophrenia or manic/mixed bipolar disorder 7-day starter pack): 1.5 mg x1 and 3 mg x6
schizophrenia
- [13 yo and older]
- Dose: 1.5-4.5 mg PO qd; Start: 0.5 mg PO qd x2 days, then incr. to 1.5 mg PO qd x2 days, then may incr. to 3 mg PO qd on day 5 and to 4.5 mg PO qd on day 8; Max: 4.5 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, manic/mixed
- [10 yo and older]
- Dose: 3-4.5 mg PO qd; Start: 0.5 mg PO qd x2 days, then incr. to 1.5 mg PO qd x2 days, then to 3 mg PO qd x3 days, then may incr. to 4.5 mg PO qd; Max: 4.5 mg/day; Info: periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: elderly patients
- caution: psychosis, dementia-associated
- caution: neuroleptic malignant syndrome history
- caution: seizure history
- caution: seizure threshold, lowered
- caution: cerebrovascular disease
- caution: cardiovascular disease
- caution: MI history
- caution: ischemic heart disease
- caution: heart failure
- caution: hypotension, orthostatic
- caution: hypovolemia
- caution: dehydration
- caution: environmental temperature, high
- caution: aspiration pneumonia risk
- caution: diabetes mellitus
- caution: diabetes mellitus risk
- caution: leukopenia history, drug-induced
- caution: neutropenia history, drug-induced
- caution: leukopenia
- caution: neutropenia
Drug Interactions .
Overview
cariprazine
atypical antipsychotic
- CYP3A4 substrate
- CNS depression
- decreases central histamine effects
- extrapyramidal effects
- hyperglycemic effects
- hyperthermia
- hypotensive effects
- lowers seizure threshold
Avoid/Use Alternative
- adagrasib
- aldesleukin
- amifampridine
- apalutamide
- aprepitant
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
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Monitor/Modify Tx
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Caution Advised
- 5-HTP
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- aclidinium inhaled
- allopurinol
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- zonisamide
Adverse Reactions .
Serious Reactions
- suicidality
- neuroleptic malignant syndrome
- extrapyramidal symptoms, severe
- tardive dyskinesia
- dystonia
- stroke
- TIA
- syncope
- hypotension, orthostatic
- seizures
- hyperglycemia
- diabetes mellitus
- dysphagia, severe
- aspiration
- hyperthermia
- hypersensitivity reaction
- Stevens-Johnson syndrome
- leukopenia
- neutropenia
- agranulocytosis
Common Reactions
- extrapyramidal symptoms
- akathisia
- insomnia
- nausea
- vomiting
- somnolence
- weight gain
- dyspepsia
- dizziness
- constipation
- restlessness
- anxiety
- BP incr.
- extremity pain
- fatigue
- blurred vision
- appetite incr.
- back pain
- xerostomia
- tachycardia
Safety/Monitoring .
Monitoring Parameters
fasting glucose, lipid panel at baseline, then periodically; CBC with diff frequently during initial tx if pre-existing or history of leukopenia/neutropenia; weight; symptoms of suicidality, clinical worsening, and/or unusual behavior changes, especially during initial tx or after dose changes; BP, HR in patients with orthostatic hypotension risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, especially in 3rd trimester; no human data available, though risk of neonatal extrapyramidal and withdrawal symptoms based on human data with other antipsychotics; risk of decr. fetal wt, fetal death, and neonatal developmental delays, based on animal data at 0.03-1.1x MRHD; possible risk of teratogenicity based on conflicting animal data at up to 3.5x MRHD
Pregnancy Registry
encourage patients to enroll in National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or www.womensmentalhealth.org
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for cariprazine: liver extensively; CYP450: 2D6, 3A4 (primary) substrate; Info: active metabolites
Excretion: for cariprazine: urine 21% (1.2% unchanged); Half-life: 2-4 days (parent drug), 1-3wk (active metabolite)
Subclass: Antipsychotics, 2nd generation ; Bipolar Disorder
Mechanism of Action
for cariprazine: exact mechanism of action unknown; partially agonizes dopamine D2 and serotonin 5-HT1A receptors, antagonizes serotonin 5-HT2A receptors
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: AbbVie Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral capsule:
- 1.5 mg (30 ea): $1,303.00
- 3 mg (30 ea): $1,303.00
- 4.5 mg (30 ea): $1,303.00
- 6 mg (30 ea): $1,303.00
oral capsule:
- 1.5 mg and 3 mg (1 dose pack, 7 capsules): $311.00
oral capsule:
- 1.5 mg (3 dose pack, 20 capsules): $2,596.00
- 3 mg (3 dose pack, 20 capsules): $2,539.00
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