LETTERS TO HEALTHCARE PROFESSIONALS

Download the PDF version of letter to healthcare professionals (August 2008)
Download the PDF version of letter to healthcare professionals (April 2009)
Download the PDF version of letter to healthcare professionals (December 2009)

Indication

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^® 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.