OMONTYS

OMONTYS®, an injectable drug used to treat anemia in dialysis patients. On February 23, 2013, Affymax, Inc. and Takeda Pharmaceutical Company announced a voluntary recall of all lots of OMONTYS® 2) Following 19 reports of anaphylaxis from dialysis centers in the United States, the FDA alerted healthcare providers about the recall, and warned that all OMONTYS® treatment should be immediately stopped. 3) To date, fatal reactions have been reported in patients following the first dose of intravenous administration. The reported serious hypersensitivity, allergic reactions, and anaphylactic shock have occurred within 30 minutes after such administration of OMONTYS®. OMONTYS ® (peginesatide) 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 vials: • 10mg Multi-dose Vials - NDC 64764-610-10 • 20mg Multi-dose vials - NDC 64764-620-20 • All lots of OMONTYS® are affected by this recall.

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