On February 23, 2013, Affymax, Inc. and Takeda Pharmaceutical Company Limited,
in conjunction with the U.S. Food and Drug Administration (FDA), initiated a
voluntary recall of all lots of OMONTYS
® (peginesatide)
Injection to the patient level due to reports regarding serious
hypersensitivity reactions, including anaphylaxis, which can be
life-threatening or fatal.
OMONTYS
® (peginesatide) is considered
not medically
necessary and, therefore, not eligible for reimbursement consideration as
of February 23, 2013.
For additional information on the recall of OMONTYS
®
(peginesatide), read the news article,
Voluntary Product Recall of the
Drug OMONTYS® (peginesatide) Injection Effective February 23,
2013, located on our Medical Policy portal.