25-Feb-13 7:00 AM  CST

All Lots of Omontys Injection Voluntarily Recalled

All lots of Omontys (peginesatide) in 10 mg and 20 mg multi-dose vials by Affymax and Takeda have been recalled due to patient hypersensitivity issues.  The FDA and drug makers have voluntarily recalled the lots due to patient hypersensitivity issues and reactions which have included anaphylaxis.  Anaphylaxis can be life-threatening or fatal for patients. 
Pharmacy technicians should note that fatal reactions have become an issue in 0.02% of patients given the initial dose in IV administration and these reactions have occurred within the first 30 minutes after the patients were given Omontys (peginesatide). 
For those pharmacy technicians that may not know, Omontys (peginesatide) is used in the treatment of anemia that is caused by chronic kidney disease in adult patients that are on dialysis. 
The lots affected are: 
• 10mg Multi-dose Vials - NDC 64764-610-10 Lots C18685, C18881, C19258.
• 20mg Multi-dose vials - NDC 64764-620-20 Lots C18686, C18696.
The FDA is recommending healthcare providers that are affected by the lots in question should discontinue use of the product for a refund.  Customers with questions about the product can call 1-855-466-6689 Monday through Friday from 9 a.m. to 5 p.m. (Eastern Standard Time).  Adverse effects due to the affected lots of Omontys (peginesatide) should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submitting a form online at www.fda.gov/Safety/MedWatch/default.htm or by calling 1-800-332-1088 to request a form by phone. 
1.  Wheeler, Sylvia and Jocelyn M. Gerst.  “Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of Omontys (peginesatide) Injection.” FDA.  Web.  23 Feb 2013.  

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

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