Aristada Approval for the Treatment of Schizophrenia
October 6, 2015 - The U.S. Food and Drug Administration (FDA) approved Aristada (aripiprazole lauroxil) extended release injection, manufactured by Alkermes. Aristada is an atypical antipsychotic, indicated for the treatment of Schizophrenia. Aristada therapy is recommended to be administered at a dose of 444mg, 6622mg, or 88mg monthly or 882mg every 6 weeks. However, tolerability should be established with oral aripiprazole prior to initiating treatment with Aristada for patients who have never been on aripiprazole.
Oral aripiprazole should be administered for 21 consecutive days in conjunction with the first Aristada injection.
Aristada is administered by a healthcare professional as an intramuscular injection as a 44mg dose in the deltoid or as either a 441mg, 662mg, or 882mg dose in the gluteal muscle. Aristada 441mg, 662mg, or 882mg single-dose pre-filled syringes will be available for purchase within the next few weeks according to Alkermes. Competing in the market share with Aristada are other branded long-acting injectable atypical antipsychotics including Abilify Maintena (aripiprazole – Otsuka), Invega Sustenna (paliperidone palmitate – Janssen), Risperdal Consta (risperidone – Janssen) and Zyprexa Relprevv (Olanzapine – Lilly).
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.