Indication and Limitations of Use

EPOGEN® is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion.
EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being.
EPOGEN® is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Average rate of Hb rise in 2 weeks with EPOGEN® use1

Data from 13 clinical studies involving IV administration of EPOGEN® to 1,010 anemic adult patients on dialysis. Starting doses were 50 to 150 Units/kg TIW. In the 3 largest studies, the median maintenance dose necessary to maintain the Hb between 10 and 12 g/dL was approximately 75 Units/kg TIW.
In clinical studies, more than 95% of patients receiving EPOGEN® for 3 months avoided RBC transfusion.1

A 26-week, placebo-controlled study of 118 patients examined exercise tolerance and patient-reported physical function2,3*

Increase in Hb levels from approximately 7 to 11 g/dL was associated with improved exercise tolerance

LIMITATIONS OF USE

  • EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being.
  • EPOGEN® is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.


Scroll down for additional Important Safety Information

Patients treated with EPOGEN® showed improvement in the number of minutes walked during a treadmill stress test, gaining approximately 1 additional minute walked on the treadmill for every 1 g/dL increase in Hb.

An increase in Hb levels from approximately 7 to 11 g/dL was associated with improved patient-reported physical function
*Reanalysis of data from the Canadian Erythropoietin Study Group (CESG), a 26-week, double-blind, placebo-controlled trial of 118 patients on dialysis with anemia of CRF with an average baseline of Hb ~ 7 g/dL. Patients were randomized to receive either EPOGEN® or placebo TIW; study Hb target range was 9.5 to 13.0 g/dL. By the end of the study, average Hb increased to ~11 g/dL in the EPOGEN®-treated patients and remained unchanged in patients receiving placebo.
SIP and KDQ are validated instruments that evaluate patient-reported outcomes.
  • Four domains from the SIP were used to assess patient-reported physical function: Physical, Home Management, Ambulation, and Body Care and Movement.
EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being.

Important Safety Information including Boxed WARNINGS

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS, AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:
  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
  • Use the lowest EPOGEN® dose sufficient to reduce the need for red blood cell (RBC) transfusions.
Cancer:
  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of 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 cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.
Perisurgery:
  • Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.
  • EPOGEN® is contraindicated in patients with:
    • Uncontrolled hypertension
    • Pure red cell aplasia (PRCA) that begins after treatment with EPOGEN® or other erythropoietin protein drugs
    • Serious allergic reactions to EPOGEN®
  • EPOGEN® from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.
  • Use caution in patients with coexistent cardiovascular disease and stroke.
  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  • Control hypertension prior to initiating and during treatment with EPOGEN®.
  • EPOGEN® increases the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
  • For lack or loss of hemoglobin response to EPOGEN®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with EPOGEN®.
    • This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
    • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which EPOGEN® is not approved).
    • If severe anemia and low reticulocyte count develop during treatment with EPOGEN®, withhold EPOGEN® and evaluate patients for neutralizing antibodies to erythropoietin.
    • Permanently discontinue EPOGEN® in patients who develop PRCA following treatment with EPOGEN® or other erythropoietin protein drugs. Do not switch patients to other ESAs.
  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with EPOGEN®. Immediately and permanently discontinue EPOGEN® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including EPOGEN®) in the postmarketing setting. Discontinue EPOGEN® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Serious and fatal reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN® multiple-dose vials. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively.
  • Adverse reactions (≥5%) in EPOGEN® clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.

Indication and Limitations of Use

EPOGEN® is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion.
EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being.
EPOGEN® is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

 

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.