How it works:
EPOGEN® is a recombinant protein that works in a similar way as the body’s natural erythropoietin — a glycoprotein produced by the kidneys that circulates through the bloodstream to bone marrow, where it stimulates red blood cell production. Red blood cells perform the essential function of transporting oxygen throughout the body. When the kidneys fail, production of erythropoietin decreases and the production of red blood cells is hindered, usually resulting in anemia.
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Amgen launched EPOGEN®, one of the first biologically derived human therapeutics, into the U.S. medical marketplace in 1989, for the treatment of anemia in patients with chronic renal failure on dialysis. EPOGEN® is also indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEN® is a recombinant protein with the same mechanism of action as endogenous human erythropoietin, a protein produced by the kidneys to stimulate the production of oxygen-transporting red blood cells.
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WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR AND THROMBOEMBOLIC EVENTS, AND TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of > 12 g/dL.
- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.
- To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
- Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: EPOGEN® (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis. |
EPOGEN® is contraindicated in patients with uncontrolled hypertension.
