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Hackensack University Medical Center
Department of Pharmaceutical and Clinical Services
EPOETIN ALFA ®
Recombinant Erythropoietin
 Epoetin alfa is a glycoprotein produced using DNA recombinant technology . It stimulates
division and differentiation of committed progenitors in the bone marrow resulting in the
production of red blood cells.
Indications (FDA-approved)
Epoetin alfa is used in the treatment of:
 Anemia of chronic renal failure with or without dialysis
 Starting dose 50-150 U/kg TIW (three times weekly) IV or SQ
 Anemia in zidovudine-treated HIV-infected patients
 Starting dose is 100 U/kg IV or SQ TIW for 8 weeks.
Treatment is for patients with endogenous serum erythropoeitin level is ≤ 500
mUnits/ml who are receiving a dose of zidovudine ≤ 4200mg/week.
 Anemia in cancer patients on chemotherapy
 Starting dose is 150 U/kg SQ TIW.
 Reduction of allogenic blood transfusion in surgical patients : “BLOODLESS SURGERY”
Indicated in anemic patients with Hgb >10 to ≤ 13 g/dl, who are scheduled to undergo
elective, non-cardiac and non-vascular surgery. Also used in patients who are high risk
for peri-operative transfusions with significant, anticipated blood loss.
 Option 1: 300 U/kg/day SQ for 10 days prior to surgery, on day of surgery and 4 days
after surgery.
 Option 2: 600 U/kg SQ in once weekly doses (21, 14 and 7 days before surgery) with a
fourth dose on the day of surgery.
 All patients should receive adequate iron supplementation
 Doses are patient specific and should be individually titrated
 A clinically significant change in hematocrit following any dosage adjustment may take up to
2 – 6 weeks
Unapproved Uses
 Severely anemic critical care patients:
 300 U/kg QD for 5 days then QOD until discharge from critical care unit
 Autologous transfusions: Enhancement of predeposited blood donation in patients with Hgb
< 13.5 or Hct < 40% and in whom the calculated blood volume is < 5 L and the expected
blood loss is  4 U.
 200-300-600 U/kg BIW for 3 weeks
Factors limiting response to epoetin alfa:
 Iron deficiency (limits hemoglobin synthesis)
 Underlying infectious, inflammatory, or malignant processes (inhibits iron transfer from storage to
bone marrow, suppresses erythropoiesis through activated macrophages)
 Occult blood loss/hemolysis (counteracts epoetin alfa-stimulated erythropoiesis)
 Underlying hematologic diseases (refractory anemia, thalassemia, myelodysplastic disorders…)
 Vitamin deficiencies: folic acid, vitamin B12 (limits hemoglobin synthesis)
Prepared by Sybil Abraham, Pharm D Student
Reviewed by Jennifer Bui, Pharm D
8/99

Aluminum toxicity (inhibits iron incorporation into heme protein)
Contraindications
 Uncontrolled hypertension
 Known hypersensitivity to mammalian cell-derived products
 Know hypersensitivity to Albumin (human)
Complications
 Hypertension>10%
 Fatigue, headache, fever >10%
 Arthralgias 1-10%
 Edema, chest pain 1-10%
 Thrombotic Events ( MI, TIA, CVA) < 1%
Monitoring
 Patient’s iron stores (serum ferritin, transferrin saturation) should be evaluated prior to
starting therapy. Transferrin saturation should be at least 20% and ferritin at least 100 ng/ml.
 Blood pressure should be adequately controlled prior and during therapy, with close
monitoring.
 Hct should be monitored twice a week at start of therapy and after any dosage change, until
stable and then should be checked at regular intervals. A rise in Hct should be seen in 2-6
weeks.
 Reticulocyte count begins to rise before Hct and is a good measure of efficacy. An increase
should be seen within 7-10 days (up to 10%).
 Hgb and CBC with differential should also be closely monitored.
Co-Medications Needed
 Iron:
 If serum ferritin is low (mild-moderate) but > 100 ng/ml, transferrin saturation 20-30%:
Ferrous sulfate PO 325 mg TID during therapy
 If ferritin is low (severe) and < 100 ng/ml or transferrin saturation is <20%: Iron dextran
IV (total IV dose is calculated based on patient’s weight, hemoglobin, amount of blood
loss if known)
 Vitamin B12
 Folic acid
References
1. Cazzola M, Mercuriali F, Brunara C. Use of Recombinant Human Erythropoietin Outside the
Setting of Uremia. Blood 1997;89(2):4248-4267
2. Corwin H, Gettinger A, Rodriguez R, et al. Efficacy of Recombinant Human Erythropoietin
in the Critically Ill Patient: A Randomized Double Blind Placebo Controlled Trial. Critical
Care Medicine 1998;26 (1):A23
3. EPOGEN®(Epoetin alfa) for injection. Package Insert. California:Amgen Inc.: Dec 1996.
4. Faris PM, Ritter MA. Epoetin Alfa, A Bloodless Approach for the Treatment of Perioperative
Anemia. Clinical Orthopaedics and Related Research 1998;357:60-67
5. Goodnough LT, Monk TG. Erythropoietin Therapy in the Perioperative Setting. Clinical
Orthopaedics and Related Research 1998;357:82-88
6. McCarthy JT. A Practical Approach to the Management of Patients with Chronic Renal
Failure. Mayo Clinical Proceedings 1999;74:269-273
7. Spivak JL. The Biology and Clinical Applications of Recombinant Erythropoietin. Seminars
in Oncology 1998;3(7):7-11
Prepared by Sybil Abraham, Pharm D Student
Reviewed by Jennifer Bui, Pharm D
8/99
Prepared by Sybil Abraham, Pharm D Student
Reviewed by Jennifer Bui, Pharm D