Affymax And Takeda Announce A Nationwide Voluntary Recall Of All Lots Of OMONTYS® (peginesatide) Injection
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Affymax Teleconference and Webcast
Affymax will host a teleconference and webcast at 5:30 a.m. Pacific Time; 8:30 a.m. Eastern Time on Monday, February 25 to further discuss this news announcement. Interested parties can listen to the live teleconference by dialing (866) 393-1565 from the U.S. or +1(973) 409-9608 for international callers. Individuals may access the live audio webcast by visiting www.affymax.com and going to the Investors section. A replay of the webcast will be available on the company’s website for 30 days following the live event.IMPORTANT SAFETY INFORMATION
|WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE.|
|Chronic Kidney Disease:|
|• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.|
|• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.|
|• Use the lowest OMONTYS dose sufficient to reduce the need for RBC transfusions.|
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