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ARISTADA INITIO

ARIPIPRAZOLE LAUROXIL

Manufacturer: Alkermes, Inc.

Score: 144.0

Quick Summary

ARISTADA INITIO is an atypical antipsychotic used for the initiation of ARISTADA treatment in adults with schizophrenia. It is administered as a single 675 mg intramuscular injection in conjunction with a 30 mg dose of oral aripiprazole. The drug has a boxed warning for increased mortality in elderly patients with dementia-related psychosis and has several contraindications, including known hypersensitivity to aripiprazole. Common adverse reactions include akathisia, injection site pain, and increased weight. The drug is not approved for use in pediatric patients or for the treatment of patients with dementia-related psychosis.

Key Clinical Findings and Indications

  • Treatment of schizophrenia in adults
  • Initiation of ARISTADA treatment
  • Single 675 mg intramuscular injection in conjunction with 30 mg oral aripiprazole

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • Known hypersensitivity to aripiprazole

Adverse Reactions

  • Akathisia
  • Injection site pain
  • Increased weight

Dosing Recommendations

General Guidance

Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers

Schizophrenia

Adult Dose

Single 675 mg intramuscular injection in conjunction with 30 mg oral aripiprazole

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Pregnancy exposure registry available
  • Limited data on use in pregnant women
  • Potential risk to fetus

Nursing Mothers

  • Not specified

Pediatric Use

  • Safety and effectiveness not established

Geriatric Use

  • Safety and effectiveness not evaluated
  • Elderly patients with dementia-related psychosis at increased risk of death