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Affymax And Takeda Announce Analyses From OMONTYS® (peginesatide) Injection Phase 3 Dialysis Studies Presented At 2012 American Society Of Nephrology Meeting

About Anemia Due to CKD in Adult Patients on Dialysis

Anemia is a common complication in CKD patients on dialysis because their kidneys are unable to produce erythropoietin, the hormone responsible for red blood cell production. Since adequate iron levels are needed for the production of red blood cells and hemoglobin, treatment guidelines recommend iron is used in conjunction with erythropoiesis-stimulating agents (ESAs) in treating anemia in dialysis patients.

As of 2010, the United States Renal Data System noted there were 410,000 people in the United States who were on dialysis.

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).

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

Indication and Limitations of Use

OMONTYS® (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease (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.

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.

Contraindications

OMONTYS is contraindicated in patients with uncontrolled hypertension.

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