Drugs Xagena
The FDA ( Food and Drug Administration ) has approved Omontys ( Peginesatide ) to treat anemia in adult dialysis patients who have chronic kidney disease ( CKD ).
Omontys is a new erythropoiesis-stimulating agent ( ESA ) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with chronic kidney disease.
Omontys is administered as a once-a-month injection.
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with chronic kidney disease who were on dialysis.
The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA ( Epoetin ) treatment.
The results have shown Omontys was as safe and effective as Epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10% or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure ( hypertension ) and joint, back, leg or arm pain ( arthralgia ).
Omontys should not be used in patients with chronic kidney disease who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling.
It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with chronic kidney disease on dialysis.
The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy ( REMS ), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data. ( Xagena )
Source: FDA, 2012
XagenaMedicine_2012
