Epoetin alfa recombinant
Epoetin alfa recombinant (Epogen)
Epoetin alfa recombinant
(ee- POH-ee-tin)
Pregnancy Category: C Epogen Eprex Procrit (Rx)

Classification: Recombinant human erythropoietin

Action/Kinetics: A 165-amino-acid glycoprotein made by recombinant DNA technology; it has the identical amino acid sequence and same biologic effects as endogenous erythropoietin (which is normally synthesized in the kidney and stimulates RBC production). Epoetin alfa will elevate or maintain the RBC level, decreasing the need for blood transfusions. t 1/2: 4-13 hr in clients with chronic renal failure. Peak serum levels after SC: 5-24 hr.

Uses: Treatment of anemia associated with chronic renal failure in adults and children, including clients on dialysis (end-stage renal disease) or adults not on dialysis. AZT-induced anemia in HIV-infected clients. Treatment of anemia in clients with nonmyeloid malignancies (Procrit only). Reduce allogeneic blood transfusions in surgery clients. Investigational: Pruritus associated with renal failure.

Contraindications: Uncontrolled hypertension. Hypersensitivity to mammalian cell-derived products or to human albumin. Use in chronic renal failure clients who need severe anemia corrected. To treat anemia in HIV-infected or cancer clients due to factors such as iron or folate deficiences, hemolysis, or GI bleeding. Anemic clients willing to donate autologous blood.

Special Concerns: Safety and efficacy have not been established in children or in clients with a history of seizures or underlying hematologic disease (e.g., hypercoagulable disorders, myelodysplastic syndromes, sickle cell anemia). Use with caution in clients with porphyria, during lactation, and preexisting vascular disease. Increased anticoagulation with heparin may be required in clients on epoetin alfa undergoing hemodialysis.

Side Effects: In Chronic Renal Failure Clients (symptoms may be due to the disease). C V: Hypertension, tachycardia, edema, MI, CV accident TIA, clotted vascular access. CNS: Headache, fatigue, dizziness, seizures. GI: Nausea, diarrhea, vomiting, worsening of porphyria. Allergic reactions: Skin rashes, urticaria, anaphylaxis. Miscellaneous: SOB, hyperkalemia, arthralgias, myalgia, chest pain, skin reaction at administration site, asthenia.
In AZT-Treated HIV-Infected Clients. C NS: Pyrexia, fatigue, headache, dizziness, seizures. Respiratory: Cough, respiratory congestion, SOB. GI: Diarrhea, nausea. Miscellaneous: Rash, asthenia, reaction at injection site, allergic reactions.
In Cancer Clients. C NS: Pyrexia, fatigue, dizziness. GI: Diarrhea, nausea, vomiting. Musculoskeletal: Asthenia, paresthesia, trunk pain. Miscellaneous: Edema, SOB, URI.
In Surgery Clients. CNS: Pyrexia, insomnia, headache, dizziness, anxiety. GI: N&V;, constipation, diarrhea, dyspepsia. CV: Hypertension, DVT, edema. Miscellaneous: Reaction at injection site, skin pain, pruritus, UTI.

Overdose Management: Symptoms: Polycythemia. Treatment: Withhold drug until hematocrit returns to the target range.

How Supplied: Injection: 2,000 U/mL, 3,000 U/mL, 4,000 U/mL, 10,000 U/mL, 20,000 U/mL

Dosage
?IV, SC Chronic renal failure.
IV, initial (dialysis or nondialysis clients), SC (nondialysis clients), initia, adults: 50-100 U/kg 3 times/week. The rate of increase of hematocrit depends on both dosage and client variation. Maintenance: Individualize (usual: 25 U/kg 3 times/week). However, doses of 75-150 U/kg/week have maintained hematocrits of 36%-38% for up to 6 months in nondialysis clients.The median dose to achieve a hematocrit of 30%-36% in children on dialysis is 167units/kg/week.
AZT-treated, HIV infections.
IV, SC, initial: 100 U/kg 3 times/week for 8 weeks (in clients with serum erythropoietin levels less than or equal to 500 mU/mL who are receiving less than or equal to 4,200 mg/week of AZT). If a satisfactory response is obtained, the dose can be increased by 50-100 U/kg 3 times/week. Evaluate the response q 4-8 weeks thereafter with dosage adjusted by 50-100 U/kg increments 3 times/week. If clients have not responded to 300 U/kg 3 times/week, it is not likely they will respond to higher doses.
Cancer clients on chemotherapy (Procrit only).
Initial, SC: 150 units/kg 3 times/week. Treatment of clients with highly elevated erythropoetin levels (> 200 mU/mL) is not recommended. If response is not satisfactory after 8 wks, the dose may be increased up to 300 units/kg 3 times/week. Clients not responding at this level are not likely to respond at higher levels. If the hematocrit exceeds 40%, withhold the dose until the hematocrit falls to 36%. When treatment is resumed, reduce the dose by 25%.
NOTE: Individualize the dose for clients on dialysis. The median dose is 75 units/kg 3 times/week (range 12.5-525 units/kg 3 times/week).
Surgery to reduce allogeneic blood transfusions.
SC: 300 U/kg/day for 10 days before surgery, on the day of surgery, and for 4 days after surgery. Alternative: 600 U/kg SC once a week 21, 14, and 7 days before surgery plus a fourth dose on the day of surgery. Iron supplementation is required at the time of epoetin therapy and continuing throughout the course of therapy.