Erythropoietin

Brand Names: Procrit

Drug Class: General Prescription

Overview

11 DESCRIPTION Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.

Mechanism of Action

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action PROCRIT stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. 12.2 Pharmacodynamics PROCRIT increases the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. The rate of hemoglobin increase varies among patients and is dependent upon the dose of PROCRIT administered. For correction of anemia in hemodialysis patients, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly. 12.3 Pharmacokinetics In adult and pediatric patients with CKD, the elimination half-life (t 1/2 ) of plasma erythropoietin after intravenous administration of PROCRIT ranged from 4 to 13 hours.

Indications

  • 1 INDICATIONS AND USAGE PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ).

Common Doses

  • 100 mcg
  • 11 g
  • 1 g
  • 10 g

Dosage

2 DOSAGE AND ADMINISTRATION Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia before initiating treatment ( 2.1 ). In pregnant women, lactating women, neonates, infants: Use only single-dose vials ( 2.1 ). Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis ( 2.2 ). Patients on Zidovudine due to HIV Infection: 100 Units/kg 3 times weekly ( 2.3 ).

Black Box Warning

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to...

Contraindications

  • 4 CONTRAINDICATIONS PROCRIT is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions (5.3) ] Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT or other erythropoietin protein drugs [see Warnings and Precautions (5.6) ] Serious allergic reactions to PROCRIT [see Warnings and Precautions (5.7) ] PROCRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions (5.9) , Use in Specific Populations (8.1 , 8.2 , 8.4) ].

Side Effects

  • 6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions (5.1) ] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Seizures [see Warnings and Precautions (5.4) ] PRCA [see Warnings and Precautions (5.6) ] Serious Allergic Reactions [see Warnings and Precautions (5.

Interactions

  • No major interactions listed on the FDA label. Always consult a healthcare professional.