New Indication for Orencia
June 30, 2017 – The U.S. FDA has granted approval for Orencia® (abatacept), manufactured by Bristol-Myers Squibb, to treat adults with psoriatic arthritis (PsA). Orencia was originally approved in 2005 to treat adults who have rheumatoid arthritis (RA), and is indicated to treat juvenile idiopathic arthritis (JIA) in patients two years of age and older.
Orencia can be used alone or in combination with other drugs. However, it should not be given in conjunction with tumor necrosis factor (TNF) inhibitors, such as Enbrel® (etanercept) or other biologicals, such as Kineret® (anakinra). Available in both intravenous (IV) injection and subcutaneous (SC) forms, Orencia is administered once a month (IV) or once a week (SC), depending on the condition being treated and the patient’s weight.
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.