Epoetin Alfa

DEA Class; Rx

Common Brand Names; Epogen, Procrit, Eprex, erythropoietin, Retacrit, epoetin alfa-epbx

• Hematopoietic Growth Factors; 
• Erythropoiesis-Stimulating Agents; 
• Recombinant Human Erythropoietins

Recombinant form of the renal hormone erythropoietin
Used for treatment of anemia and for reduction of allogeneic red blood cell transfusions in surgical patients
Associated with increased risk of death, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis, and tumor progression or recurrence

Indicated for the treatment of anemia.

Hypersensitivity to epoetin alfa or albumin or mammalian cell-derived products

Cancer patients whose anemia is caused by factors other than chemotherapy

Uncontrolled hypertension

Pure red-cell aplasia that begins after treatment with any erythropoietin protein drugs

Use of multidose vials containing benzyl alcohol in neonates, infants, or pregnant or nursing females

• Pyrexia (10-42%)
• Nausea (11-35%)
• Hypertension (14-27%)
• Cough (4-26%)
• Vomiting (12-28%)
• Pruritus (12-21%)
• Rash (2-19%)
• Headache (5-18%)
• Arthralgias (10-16%)
• Arthralgia (10%)
• Myalgia (10%)
• Stomatitis (10%)
• Diarrhea (9%)
• Dizziness (9%)
• Edema (9%)
• Fatigue (9%)
• Weight decrease (9%)
• Medical device malfunction (artificial kidney clotting during dialysis) (8%)
• Vascular occlusion (vascular access thrombosis) (8%)
• Vomiting (8%)
• Asthenia (7%)
• Chest pain (7%)
• Injection-site irritation (7%)
• Muscle spasm (7%)
• Upper respiratory tract infection (URTI) (7%)
• Urticaria (3%)
• Seizures (2.5%)
• Pulmonary embolism (1%)
• Respiratory tract congestion (1%)

Increased incidence of death, myocardial infarction (MI), stroke, and thromboembolism: Using ESAs to target hemoglobin level of >11 g/dL increases risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit (see Black Box Warnings)

Use caution in hypertension, iron deficiency, folate or B12 deficiency, congestive heart failure (CHF), coronary artery disease (CAD), seizure disorder, sickle-cell disease, hemolytic anemia, porphyria, hematologic disorders

Cancer patients: Increased tumor progression rate when dosed to achieve hemoglobin level of >12 mg/dL

Chronic renal failure: At initiation of therapy, transferrin saturation should be ≥20% and ferritin ≥100 ng/mL

Patients undergoing surgery are at increased risk for DVT; concomitant DVT prophylaxis is strongly recommended

Epogen multidose formulations contain benzyl alcohol, which is associated with potentially fatal “gasping syndrome” in premature neonates

Zidovudine-treated patients may show response only when zidovudine dosage <4200 mg/wk and endogenous epoetin <500 U/mL

To prescribe or dispense to patients with cancer and anemia due to myelosuppressive chemotherapy, prescribers and hospitals must enroll in and comply with ESA APPRISE Oncology Program

Increased risk of seizures during first 90 days of therapy in CKD; monitor closely

Dialysis patients: IV administration recommended to reduce red-cell aplasia risk; increased anticoagulation with heparin may be required to prevent clotting of extracorporeal circuit during hemodialysis

Do not increase dose more frequently than once monthly

Contains albumin; may carry extremely remote risk for transmission or viral diseases or Creutzfeldt-Jakob disease

Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN), reported in the postmarketing setting; discontinue therapy immediately if severe cutaneous reaction, such as SJS/TEN, is suspected

Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin reported in patients treated with epoetin alfa

Limited data available on epoetin alfa use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes

There is no information regarding the presence of epoetin alfa products in human milk, the effects on the breastfed infant, or the effects on milk production

Varies depending on indication, frequency of administration, and individual response; for patients with cancer, doses up to 60,000 units IV weekly until completion of chemotherapy.

Varies depending on indication, frequency of administration, and individual response; for patients with cancer, doses up to 60,000 units IV weekly until completion of chemotherapy.

Varies depending upon indication, frequency of administration, and individual response. For patients with cancer, 900 units/kg/week IV (Max: 60,000 units) until completion of chemotherapy. A limited number of HIV-infected adolescents have been treated off-label with doses up to 400 units/kg/dose subcutaneously/IV 3 times per week.

5 to 12 years: Varies depending upon indication, frequency of administration, and individual response. For patients with cancer, 900 units/kg/week IV (Max: 60,000 units) until completion of chemotherapy. A limited number of HIV-infected children have been treated off-label with doses up to 400 units/kg/dose subcutaneously/IV 3 times per week.
1 to 4 years: Varies depending upon indication, frequency of administration, and individual response; a limited number of HIV-infected children have been treated off-label with doses up to 400 units/kg/dose subcutaneously/IV 3 times per week.

8 to 11 months: Varies depending upon indication, frequency of administration, and individual response; a limited number of HIV-infected infants have been treated off-label with doses up to 400 units/kg/dose subcutaneously/IV 3 times per week.
1 to 7 months: Varies depending upon indication, frequency of administration, and individual response.

Safety and efficacy have not been established; however, doses up to 2,500 units/kg/dose subcutaneously/IV have been used off-label for hypoxic-ischemic encephalopathy.

Epoetin alfa

injectable solution

• 2000 units/mL (Epogen, Procrit, Retacrit)
• 3000 units/mL (Epogen, Procrit, Retacrit)
• 4000 units/mL (Epogen, Procrit, Retacrit)
• 10,000 units/mL (Epogen, Procrit, Retacrit)
• 20,000 units/mL (Epogen, Procrit, Retacrit)
• 40,000 units/mL (Retacrit)

Biosimilar to Epogen and Procrit

• Retacrit (epoetin alfa-epbx)