EPOGEN® (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for READ MORE
EPOGEN® (epoetin alfa) 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.
Limitations of Use:
Improvements in exercise tolerance2
Improvements in patient-reported physical function2
EPOGEN® has not been shown to improve quality of life, fatigue, or patient well-being
Patients have received
EPOGEN® since FDA approval4,§
*Data from 13 clinical studies involving IV administration of EPOGEN® to 1010 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.1
†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 chronic renal failure 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.2,3
‡SIP and KDQ are validated instruments that evaluate patient-reported outcomes.
§In the postmarketing setting from launch through December 31, 2020. Data on incident and prevalent number of patients on dialysis and market share are used to estimate number of patients exposed.
FDA = Food and Drug Administration; Hb = hemoglobin; TIW = three times a week; IV = intravenous.
Dose and corresponding rise in Hb in 2 weeks with EPOGEN® TIW dosing1
|STARTING DOSE (3 times weekly intravenously)||HEMOGLOBIN INCREASE
IN 2 WEEKS
|50 Units/kg||0.5 g/dL|
|100 Units/kg||0.8 g/dL|
Data from 13 clinical studies involving IV administration of EPOGEN® to 1010 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.1
EPOGEN® is available in single-dose
and multidose vials1
EPOGEN® vials not shown at actual size. Not all vial sizes shown.
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target a Hb level of greater than 11 g/dL.
No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks.
Individualize dosing and use the lowest dose of EPOGEN® sufficient to reduce the need for RBC transfusions.
Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions.
Following initiation of therapy and after each dose adjustment, monitor Hb at least weekly until the Hb level is stable and sufficient to minimize the need for RBC transfusion. Thereafter, Hb should be monitored at least monthly, provided that Hb levels remain stable.
When adjusting therapy, consider Hb rate of rise, rate of decline, ESA responsiveness, and Hb variability.
If Hb rises rapidly (eg, more than 1 g/dL in any 2-week period), reduce the dose by 25% or more, as needed, to reduce rapid responses.
FOR ADULT PATIENTS WITH CKD:
FOR PEDIATRIC PATIENTS (ages 1 month or older):
If the Hb has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25% when appropriate.
Patients with CKD and an insufficient Hb response to ESA therapy or a rate of Hb rise of > 1 g/dL over 2 weeks may be at an even greater risk for cardiovascular reactions and mortality than other patients.
EPOGEN® (epoetin alfa) 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: