1
INDICATIONS AND USAGE
Epogen is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).- Zidovudine in patients with HIV-infection (1.2).- The effects of concomitant myelosuppressive chemotherapy,and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3).
Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).
Limitations of Use
Epogen has not been shown to improvequality of life, fatigue, or patient well-being (1.5).
Epogen is not indicated for use:
In patients with cancer receiving hormonal agents,biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.5).
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).
In patients with cancer receiving myelosuppressive chemotherapy
in whom the anemia can be managed by transfusion (1.5).
In patients scheduled for surgery who are willing to donate autologous blood (1.5).
In patients undergoing cardiac or vascular surgery (1.5).
As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.5).
1.1
Anemia Due to Chronic Kidney Disease
Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysisto decrease the need for red blood cell (RBC) transfusion.
1.2
Anemia Due to Zidovudine in Patients with HIV-infection
Epogen is indicated for the treatment of anemia due to zidovudine administered at
4200 mg/week in patients withHIV-infectionwith endogenous serum erythropoietin levels of
500 mUnits/mL.
1.3
Anemia Due to Chemotherapy in PatientsWith Cancer
Epogen is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressivechemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
1.4
Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
Epogen is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperativehemoglobin> 10 to
13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.Epogen is not indicated for patients who are willing to donate autologous blood pre-operatively.
1.5
Limitations of Use
Epogen has not been shown to improve quality of life, fatigue, or patient well-being.
Epogen is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
In patients scheduled for surgery who are willing to donate autologous blood.
In patients undergoing cardiac or vascular surgery.
As a substitute for RBC transfusions in patients who require immediate correction of anemia.