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Epoetin alfa is considered medically necessary for a period of three months if any of the following criteria are met.

1. Diagnosis of chronic renal failure on dialysis (end-stage renal disease) or not yet on dialysis with hematocrit (Hct) < 36% (HCPC Code Q4055).
2. Treatment of anemia associated with chemotherapy for non-myeloid malignancies with Hct <30% (HCPC Code Q0136).
3. Treatment of anemia in patients scheduled to undergo elective, non-cardiac, non-vascular surgery with ALL of the following (HCPC Code Q0136):
   1. Hemoglobin (Hgb) between 10 and 13 gm/d/
   2. Not a candidate of autologus blood transfusion
   3. Expected blood loss of more than 2 unitls
4. Treatment of anemia associated with zidovudine (AZT) therapy for HIV with Hgb < 11 gm/dl or Hct < 33% (HCPC Code Q0136).
5. Treatment of anemia associated with Hepatitis C being treated with the combination of ribavirin and interferon alfa or ribavirin and peg interferon alfa with Hgb < 11 gm/dl or Hct < 33% (HCPC Code  Q0136).
6. Anemia from myelodysplastic syndrome with Hgb < 11 gm/dl or Hct < 33% (HCPC Code Q0136).
7. Anemia of prematurity of infants with a birth weight < 1,500 gm or gestational age < 33 weeks and Hct < 33% (HCPC Code Q0136).

Description:

Erythropoetin is a glycoprotein that stimulates red blood cell production. It is produced in the kidney and stimulates the division of and differentiation of committed erythroid progenitors in the bone marrow. Epoetin alfa (Epogen, Procrit) is a glycoprotein produced by recombinant DNA technology which has the same biological activity as the endogenous hormone.

Erythropoetin Alfa (Epogen, Procrit) dosage:

For the treatment of anemia:

Adults and adolescents > 16 years: Initially, 50—100 units/kg IV/SC three times a week. The manufacturer suggests a target Hgb range of 10—12 g/dl. Reduce epoetin dosage by approximately 25% if there is a rapid increase (i.e., more than 1 g/dl in any 2-week period) in hemoglobin (Hgb) or if the Hgb is increasing and approaches 12 g/dl. If the Hgb continues to increase, temporarily interrupt epoetin therapy to attain the Hgb target goal, and then reinstate therapy at approximately 25% below the prior dosage. If the Hgb does not increase by 1 g/dl after 4 weeks of therapy and iron stores are adequate, increase the dose by approximately 25%. Dosage adjustments should not be made more frequently than once a month, unless clinically indicated. Following a dose adjustment, the Hgb should be determined at least twice weekly for 2—6 weeks. If the Hgb remains below or falls below the target range, re-evaluate iron stores.
Adolescents <= 16 years, children, and infants > 1 month on dialysis: 50 units/kg IV/SC three times a week initially. For dosage adjustments, see adult dosage.
Adolescents <= 16 years, children, and infants > 1 month not on dialysis†: In pediatric patients with chronic renal failure who do not require dialysis, epoetin alfa 50—250 units/kg SC/IV 1—3 times weekly has been shown to increase Hgb levels and decrease transfusion requirements. For dosage adjustments, see adult dosage.

Subcutaneous or intravenous dosage (Maintenance dosage):
Adults and adolescents > 16 years: Individualized according to patient response. The median maintenance dose for adult hemodialysis patients is 75 units/kg SC/IV three times weekly (range: 12.5—525 units/kg three times weekly). Over 95% of patients with chronic renal failure respond to epoetin alfa therapy, and virtually all patients are transfusion-independent within 2 months of starting treatment.

Adolescents <= 16 years, children, and infants > 1 month on dialysis: In pediatric hemodialysis and peritoneal dialysis patients, the median maintenance dose was 167 units/kg/week (49—447 units/kg/week) and 76 units/kg/week (24—323 units/kg/week), respectively, IV/SC in divided doses 2—3 times a week to achieve a target HCT of 30—36%.For the treatment of zidovudine-induced anemia in HIV-infected patients with circulating endogenous erythropoietin concentrations < 500 mUnits/ml who are receiving a dose of zidovudine <= 4200 mg/week:

For the treatment of zidovudine-induced anemia in HIV-infected patients with circulating endogenous erythropoietin concentrations < 500 mUnits/ml who are receiving a dose of zidovudine <= 4200 mg/week:

Adults: Initially, 100 units/kg SC/IV 3x/week for 8 weeks. If response is unsatisfactory after 8 weeks, the dose may be increased by 50—100 units/kg 3x/week. May adjust dosage every 4 to 8 weeks in increments of 50—100 units/kg 3x/week. If the response is insufficient at 300 units/kg 3x/week, it is unlikely that patients will respond to higher doses. If the Hgb exceeds 13 g/dl, discontinue therapy until the Hgb drops to 12 g/dl. The dose should be reduced by 25% when treatment is resumed and then titrated to desired effect.
Adolescents, children, and infants >= 8 months†: Pediatric HIV-infected patients have been treated with epoetin alfa 50—400 units/kg SC/IV 2—3 times per week. Increases in Hgb levels and reticulocyte counts, and decreases in or elimination of blood transfusions have been observed.

For the treatment of anemia in patients with non-myeloid malignancies where the anemia is due to the effect of concomitantly administered chemotherapy and the chemotherapy is administered for at least 2 months:

Adults: 150 units/kg SC three times weekly, initially. If the response is not adequate after 8 weeks the dosage may be increased to 300 units/kg SC three times weekly. If response is unsatisfactory at a dose of 300 units/kg, it is unlikely that they will respond to higher doses. Alternatively, a starting dose of 40,000 units SC weekly may be used initially. If after 4 weeks of therapy, the hemoglobin has not increased by >= 1 g/dL, in the absence of red blood cell transfusion, the epoetin dose should be increased to 60,000 units SC weekly. If patients have not responded satisfactorily to the increased dosage, it is unlikely that they will respond to doses > 60,000 units weekly. The manufacturer suggests a target Hgb range of 10—12 g/dl. Reduce epoetin dosage by approximately 25% if there is a rapid increase (i.e., more than 1 g/dl in any 2-week period) in hemoglobin (Hgb) or if the Hgb is increasing and approaches 12 g/dl. If the Hgb exceeds 13 g/dl, discontinue therapy until the Hgb drops to 12 g/dl. The dose should be reduced by 25% when treatment is resumed and then titrated to desired effect. Clinical practice guidelines recommend the use of epoetin alfa in patients with chemotherapy-associated anemia with a hemoglobin level < 10 g/dl.

Adolescents, children, and infants > 6 months†: Epoetin alfa dosages of 25—300 units/kg SC/IV 3—7 times per week have been given. Increases in Hgb levels and reticulocyte counts, and decreases in or elimination of blood transfusions have been observed.

To reduce the need for allogenic blood transfusions in anemic patients (hemoglobin > 10 and <= 13 g/dl) scheduled to undergo elective, noncardiac, nonvascular surgery:

Adults: 300 units/kg/day SC for 10 days before surgery, on the day of surgery, and for 4 days after surgery. Alternatively, 600 units/kg SC once weekly, 21, 14, and 7 days before surgery plus one dose on the day of surgery. All patients should receive adequate iron supplementation during epoetin alfa therapy.

For the treatment of anemia of prematurity, in combination with iron supplementation: Premature neonates: Various dosage regimens have been used. One regimen that has been used successfully is 25—100 units/kg SC three times weekly. Alternative regimens include 100 units/kg SC 5 times per week or 200 units/kg SC every other day for 10 days.

For the treatment of anemia associated with myelodysplastic syndrome:

Adults: Epoetin alfa 150—300 units/kg SC three times weekly has been shown to improve anemia in about 20% of patients with MDS. When epoetin alfa is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony stimulating factor (G-CSF), response increases to about 50% of MDS patients.

Adverse events reported during therapy with Epoetin include hypertension, headache, flu-like symptoms, GI effects and skin rash.

Erythropoetin Alfa (Epogen, Procrit) is pregnancy category C.

References:

Rizzo JD, Lichtin AE, Woolf SH, et al. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. J Clin Oncol 2002; 20:4083—107.

Reiter PD, Rosenberg AA, Valuck RJ. Factors associated with successful epoetin alfa therapy in premature infants. Ann Pharmacother 2000; 34:433—9.

Ross SD, Allen IE, Henry DH, Seaman C, Sercus B, Goodnough LT. Clinical benefits and risks associated with epoetin and darbepoetin in patients with chemotherapy-induced anemia: a systematic review of the literature. Clin Ther. 2006 Jun; 28(6):801-31.