Affymax, Inc. and Takeda Pharmaceutical Co. Ltd. have voluntarily recalled all lots of OMONTYS (peginesatide) Injection as a result of postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis. The companies have been working with the FDA and issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS, which is indicated for the treatment of anemia due to chronic kidney disease.
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 occurred within 30 minutes after administration. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session.