CLINICAL EXPERIENCE

Proven clinical experience in anemia management

EPOGEN^® has been used to treat anemia for over 15 years with more than 4 million patient-use years of experience²¹

This estimate represents the person-time of experience accrued by all patients in the post-marketing setting from market launch through April 2009. This figure is based on US Renal Data System (USRDS) estimates of US dialysis patients and EPOGEN^® market penetration data as reported by OutcomesPlus.

Over 95% of patients responded with a clinically significant increase in hematocrit (Hct) in 12 weeks with EPOGEN^®^2,6

(+)

Data from a Phase 3, multicenter clinical trial of patients on hemodialysis with uncomplicated anemia (Hct < 0.30; N = 333). The mean Hct values at biweekly intervals for 201 patients receiving EPOGEN^® 150 U/kg IV TIW are shown above. (Adapted from Eschbach et al, Ann Intern Med, 1989.⁶) The Hb target range for this study was Hct 32% to 38% (Hb 10.7 to 12.8 g/dL).

The EPOGEN^® PI recommends:
Individualize dose to achieve and maintain Hb levels within the range of 10 to 12 g/dL. Please see "Complete Dosing Guidelines".

In a different study, patients treated with EPOGEN^® experienced improvement in exercise tolerance and patient-reported physical functioning at month 2 that was maintained throughout the study^2,21

Patients treated with Epoetin alfa showed improvement in the number of minutes walked in the treadmill stress test^2,21
In the same study, patients treated with Epoetin alfa reported improvement in overall physical functioning. Measurements of physical functioning included body care and movement, mobility, and ambulation^2,21

In a 26-week, double-blind, placebo-controlled trial, 118 anemic dialysis patients with an average Hb of approximately 7 g/dL were randomized to either EPOGEN^® or placebo. By the end of the study, average Hb increased to approximately 11 g/dL in the EPOGEN^®-treated patients and remained unchanged in patients receiving placebo.

Broad clinical experience in a wide variety of patients on dialysis with anemia, including those who are:

New to dialysis²²
Recently hospitalized³
Have infections and/or inflammation²³

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.