New Dosage Approved for Aristada
June 5, 2017 – A fourth strength (1,064mg) of Aristada® (aripiprazole lauroxil) extended-release, manufactured by Alkermes, has been approved by the U.S. FDA. An injectable suspension used for treating schizophrenia, Aristada is now available in single-use, prefilled syringes containing 441mg, 662mg, 882mg or 1,064mg. Low doses are given once every four weeks or once every six weeks by a healthcare professional. The highest dose is administered only once every eight weeks. The lowest dose of Aristada is injected into the muscle of the upper arm, with all other doses injected in the buttock.
Aristada carries a black box warning that antipsychotic drugs, including Aristada, increase the risk of death when used for elderly patients whose psychosis is caused by dementia.
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.