People who are undergoing dialysis and have anemia caused by chronic kidney disease may receive a monthly injection of Omontys. This prescription drug is given through an intravenous (IV) infusion or as an injection just under the skin. It is given once a month and is approved for use in adults only. Side effects may include diarrhea, nausea, and shortness of breath.
In February 2013, Omontys was pulled from the market (all of the product was recalled) to investigate reports of dangerous allergic reactions, including fatal anaphylactic reactions, which appear to be occurring more frequently than anticipated. This medication will not be available until further notice.
What Is Omontys?
Omontys® (peginesatide) is a prescription medication approved to treat anemia caused by chronic kidney disease (CKD) in adults on dialysis. It is injected just once a month.
Omontys is jointly marketed by Affymax, Inc., and Takeda Pharmaceuticals America, Inc.
How Does Omontys Work?
Omontys belongs to a group of medications known as erythropoiesis-stimulating agents (ESAs). It works by stimulating the production of red blood cells by the bone marrow.
Studies have compared Omontys to epoetin alfa (a similar medication) or epoetin beta (a similar medication available in Europe) for treating anemia caused by chronic kidney disease. These studies evaluated the effectiveness of the medications by measuring the level of hemoglobin (a protein found in red blood cells). These studies showed that using Omontys once a month produced similar results as using epoetin one to three times a week.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA alerts health care providers of recall of anemia drug Omontys (February 24, 2013). FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340899.htm. Accessed March 5, 2013.
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