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Affymax And Takeda Announce OMONTYS® Data Presentations At The American Society Of Nephrology Kidney Week 2012

OMONTYS is approved for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is not indicated, and is not recommended, for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life. Please see additional Important Safety Information including Boxed WARNINGS below.

About OMONTYS

OMONTYS ® (peginesatide) Injection is a synthetic, pegylated, peptide-based ESA, and its building blocks (amino acids) are arranged in a different order than erythropoietin (i.e., it has no sequence homology to endogenous erythropoietin). 1,2

On March 27, 2012, the FDA approved OMONTYS (dosed once-monthly) for the treatment of anemia due to CKD in adult patients on dialysis. 1

About Anemia Due to CKD in Adult Patients on Dialysis

Anemia is a complication of CKD and is associated with cardiovascular illness and mortality. 1 As of 2010, the United States Renal Data System noted there were more than 410,000 people in the United States who were on dialysis. 2

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 red blood cell (RBC) transfusions.

 

Contraindications

Omontys is contraindicated in patients with uncontrolled hypertension.

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