What are the indications for Procrit (epoetin alfa)?

Indications for Procrit (Epoetin Alfa)

Procrit is FDA-approved for four primary indications: anemia of chronic kidney disease (CKD), chemotherapy-induced anemia in cancer patients, anemia in HIV patients on zidovudine, and reduction of allogeneic blood transfusion in surgery patients. 1

1. Anemia of Chronic Kidney Disease

Procrit is indicated for treating anemia caused by insufficient erythropoietin production in patients with CKD, whether on dialysis or not. 2, 1

Dosing and Initiation

• Initial dose: 50-100 Units/kg three times weekly for adults; 50 Units/kg three times weekly for pediatric patients 1
• Intravenous route is recommended for hemodialysis patients 1
• Iron status must be assessed and adequate iron stores ensured before initiating therapy 2, 1

Critical Safety Parameters

• Do NOT target hemoglobin levels above 11 g/dL, as this increases mortality, myocardial infarction, stroke, and thromboembolism risk 1
• Targeting hemoglobin >13 g/dL has been associated with increased mortality and cardiovascular events 2
• Control hypertension prior to and during treatment 1

Common Pitfalls to Avoid

• Failing to assess and correct iron deficiency before and during treatment leads to inadequate response 2
• Targeting hemoglobin above 12 g/dL increases cardiovascular event risk 2
• Overlooking other causes of anemia (inflammation, infection, blood loss, hyperparathyroidism, folate deficiency) 2

2. Chemotherapy-Induced Anemia in Cancer Patients

Procrit is indicated for treating anemia in cancer patients receiving myelosuppressive chemotherapy when the anticipated outcome is NOT cure and hemoglobin has decreased to <10 g/dL. 3, 1

When to Initiate Treatment

• Begin treatment when hemoglobin falls below 10 g/dL 3
• For hemoglobin between 10-12 g/dL, clinical circumstances should guide the decision 3
• RBC transfusion remains an alternative option depending on severity and clinical circumstances 3

Dosing Regimens

• Adults: 40,000 Units weekly OR 150 Units/kg three times weekly 1
• Pediatric patients ≥5 years: 600 Units/kg intravenously weekly 1
• Dose escalation should occur if inadequate response after 4 weeks 3
• Discontinue if no response after 6-8 weeks 3

Critical Contraindications in Cancer

• Do NOT use in cancer patients NOT receiving chemotherapy—this increases mortality risk 3, 1
• Do NOT use when the anticipated outcome is cure 3
• Particular caution with diseases/agents that increase thromboembolism risk 3

Monitoring Requirements

• Titrate dose once hemoglobin reaches 12 g/dL 3
• Reduce dose if hemoglobin rises >1 g/dL in any 2-week period 2
• Monitor for increased risk of tumor progression or recurrence 1

3. Anemia in HIV Patients on Zidovudine

Procrit is indicated for treating anemia related to zidovudine therapy in HIV-infected patients. 1

Dosing

• 100 Units/kg three times weekly 1
• Common adverse reactions include pyrexia, cough, rash, and injection site irritation 1

4. Reduction of Allogeneic Blood Transfusion in Surgery Patients

Procrit is indicated to reduce allogeneic blood transfusion requirements in patients scheduled for elective, noncardiac, nonvascular surgery. 1

Dosing Regimens

• 300 Units/kg per day for 15 days (10 days before surgery, day of surgery, and 4 days after) 1
• Alternative: 600 Units/kg weekly (21,14, and 7 days before surgery, plus day of surgery) 1

5. Special Population: Myelodysplastic Syndromes (MDS)

ESAs including Procrit may be used in select MDS patients, particularly those with low to intermediate-1 IPSS risk, baseline serum EPO <500 IU/L, and lower transfusion burden. 3

Response Predictors

• Baseline serum EPO <500 IU/L predicts better response 3
• Refractory anemia (RA) or RA with ringed sideroblasts (RARS) subtypes respond better 3
• Response rates: 27.3% in controlled trials, up to 59.4% with higher dosing 3

Safety in MDS

• No increased risk of leukemic transformation demonstrated in meta-analyses 3
• No association with thrombosis in MDS patients (unlike solid tumors) 3

Absolute Contraindications

• Uncontrolled hypertension 1
• Pure red cell aplasia (PRCA) following treatment with any erythropoietin product 1
• Serious allergic reactions to epoetin alfa products 1
• Multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women 1

Essential Pre-Treatment Requirements

• Evaluate and correct iron deficiency before initiating therapy 1
• Correct or exclude other causes of anemia 1
• Assess cardiovascular risk factors and control hypertension 1
• In pregnant women, lactating women, neonates, and infants: use only single-dose vials 1

Monitoring During Therapy

• Monitor hemoglobin at least weekly until stable, then regularly 1
• Increase seizure monitoring in CKD patients 1
• Watch for signs of PRCA (severe anemia with low reticulocyte count) 1
• Monitor blood pressure throughout treatment 1