AUDIENCE: Patients, Healthcare Professionals, Nephrology, Hematology
ISSUE: Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal.
To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.
BACKGROUND: Omontys (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg Multi-dose vials:
- 10mg Multi-dose Vials - NDC 64764-610-10 Lots C18685, C18881, C19258
- 20mg Multi-dose vials - NDC 64764-620-20 Lots C18686, C18696
All lots of Omontys are affected by this recall and distributed nationwide, including Puerto Rico and Guam, to dialysis centers via specialty distributors.
RECOMMENDATION: Dialysis organizations are instructed to discontinue use. Customers will be provided instructions on how to return the product to the manufacturer for a refund. For customers with questions, please call 1-855-466-6689, 9:00 a.m. to 5:00 p.m. Eastern Standard Time, Monday through Friday.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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.
[02/23/2013 - Firm Press Release - Affymax and Takeda]
[02/24/2013 - News Release - FDA]