EPOGEN® (Epoetin alfa) Coverage and Reimbursement

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EPOGEN® Coverage and Reimbursement

Medicare Resources

Product Information

Indications

EPOGEN® (Epoetin alfa) is indicated for the treatment of anemia in patients with chronic renal failure (CRF) on dialysis. EPOGEN® is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.

Important Safety Information, including Boxed WARNINGS

WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE

Chronic Renal Failure:

  • In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
  • Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense EPOGEN® (Epoetin alfa) to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
  • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery: EPOGEN® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

  • EPOGEN® (Epoetin alfa) is contraindicated in patients with uncontrolled hypertension.
  • Patients with chronic renal failure (CRF) participating in clinical studies experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
  • Patients with CRF and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular events and mortality than other patients.
  • These events included myocardial infarction, stroke, congestive heart failure, and hemodialysis vascular access thrombosis.
  • A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
    • This has been reported predominantly in patients with CRF receiving ESAs by subcutaneous administration.
    • PRCA has also been reported in patients receiving ESAs while undergoing treatment for hepatitis C with interferon and ribavirin.
    • A sudden loss of response to EPOGEN®, accompanied by severe anemia and low reticulocyte count, should be evaluated.
    • If anti-erythropoietin antibody-associated anemia is suspected, withhold EPOGEN® and other ESAs. EPOGEN® should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other ESAs as antibodies may cross-react.
  • Seizures have occurred in patients with CRF participating in EPOGEN® clinical trials.
  • The most commonly reported side effects in clinical trials were hypertension, headache, arthralgias, and nausea.

  • Additional Resources