Omontys Causes Serious Hypersensitivity Reactions

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OMONTYS (peginesatide) 10mg/mL multiple-use vial by Affymax and Takeda
OMONTYS (peginesatide) 10mg/mL multiple-use vial by Affymax and Takeda

Affymax and Takeda informed the public of a voluntary recall of all lots of Omontys (peginesatide) Injection as a result of post-marketing reports regarding serious hypersensitivity reactions, including anaphylaxis. Omontys is an erythropoiesis-stimulating agent indicated for anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

The serious hypersensitivity reactions were reported to have occurred within 30 minutes after the first dose of intravenous administration. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. 

The affected lots are as follows:

  • 10mg multi-dose vials (Lot # C18685, C18881, C19258)
  • 20mg multi-dose vials (Lot # C18686, C18696)

Dialysis organizations are recommended to discontinue use. Customers will be provided instructions on how to return the product to the manufacturer for a refund.

For more information call (855) 466-6689 or visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340895.htm
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