Aristada Initio Approved to Treat Schizophrenia
July 2, 2018 – The U.S. FDA has approved Aristada Initio® (aripiprazole lauroxil), an extended release form of the long-acting atypical antipsychotic drug, Aristada® (aripiprazole lauroxil). Both products are manufactured by Alkermes, and indicated to treat schizophrenia in adult patients.
For patients with schizophrenia, transitioning to new therapy or from an inpatient to outpatient setting can be difficult. Aristada Initio provides a treatment option that may ease these transitions. Aristada Initio uses proprietary NanoCrystal® technology to improve absorption and help patients achieve appropriate levels of medication in the body more quickly.
Aristada Initio is not intended for repeat dosing, and is not interchangeable with Aristada. Patients who begin their treatment regimen with Aristada Initio should receive the standard formulation of Aristada for maintenance care.
Under the recommended dosing, a single 675mg intramuscular injection of Aristada Initio should be given in conjunction with the patient’s first dose of standard Aristada and one 30mg dose of oral aripiprazole. A black box warning cautions that antipsychotic drugs like Aristada Initio may increase the risk of death in elderly patients who have dementia-related psychosis, and should not be used in these patients.
Alkermes has launched Aristada Initio at an average wholesale price (AWP) of $2,243.47 per syringe.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.