Epoetin Alfa

Renogen®

Prescription Drug

Indication

• Treatment of anemia with renal insufficiency or chronic renal failure (CRF)
  • In adult and pediatric patients on dialysis
  • Treatment of severe anemia of renal origin accompanied by clinical symptoms in patients with renal insufficiency not yet undergoing dialysis

Note: Epoetin alfa is not intended for patients who require immediate correction of severe anemia

• Treatment of anemia in Zidovudine-treated HIV-infected patients to elevate or maintain the red blood cell (RBC) level (as shown by hematocrit or hemoglobin determinations) and to decrease the need for transfusions

• Treatment of anemia in cancer patients on chemotherapy
  • Epoetin alfa is indicated for the treatment of anemia due to the effect of concomitantly administered chometherapy to reduce the need for RBC transfusions in patients with metastatic, non-myeloid malignancies receiving chemotherapy for a minimum of two months

Note: 

• Epoetin alfa is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy, unless receiving concomitant myelosuppressive chemotherapy
• Epoetin alfa is not indicated for patients receiving therapy when the anticipated outcome is cure
• Epoetin alfa is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding
• Epoetin alfa has not been proven to improve symptoms of anemia, quality of life, fatigue, or patient well-being

• Reduction of allogeneic blood transfusion in adult surgery patients
  • For the treatment of anemic patients (hemoglobin > 10 to ≤ 13 g/dL) who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusion and to facilitate erythropoietic recovery.
  • To augment erythropoiesis in the perisurgical period to reduce allogeneic blood transfusions and correct postoperative anemia in adult non-iron deficient patients undergoing major elective orthopedic surgery. Restrict use to patients with moderate anemia (i.e., 10-13 g/dL) who do not have an autologous predonation program available and with expected moderate blood loss (900-1800 mL). Always use good blood management in the perisurgical setting.
  • To augment autologous blood collection in a pre-deposit program and to limit the decline in hemoglobin in anemic patients scheduled for major elective surgery requiring a large volume of blood, i.e., ≥ 4 units for females and ≥ 5 units for males, who are not expected to pre-deposit their complete peri-operative blood needs.  

Note: Epoitin alfa is not indicated for anemic patients who are willing to donate autologous blood.

Dosage and Administration

For more information on safety, precaution and other information about this product, please see the Product Insert.