Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions
AUDIENCE: Patients, Healthcare Professionals, 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
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
• 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.
Posted: February 2013