epoetin alfa (EPO, erythropoietin)
(e poe e' tin)
Epogen, Eprex (CAN), Procrit
Pregnancy Category C
Recombinant human erythropoietin
A natural glycoprotein produced in the kidneys, which stimulates RBC production in the bone marrow.
· Treatment of anemia associated with chronic renal failure, including patients on dialysis
· Treatment of anemia of renal failure requiring dialysis ages 1 mo–16 yr; not recommended for < 1 mo
· Treatment of anemia related to therapy with AZT in HIV-infected patients
· Treatment of anemia related to chemotherapy in cancer patients
· Reduction of allogenic blood transfusions in surgical patients
· Unlabeled use: Pruritus associated with renal failure; to decrease the number of RBC transfusions in critically ill infants who have anemia of prematurity, myelodysplastic syndrome, chronic inflammation associated with rheumatoid arthritis
Contraindications and cautions
· Contraindicated with uncontrolled hypertension; hypersensitivity to mammalian cell-derived products or to albumin human.
· Use cautiously with pregnancy, lactation.
Injection—2,000, 3,000, 4,000, 10,000, 20,000, 40,000 units/mL
· Anemia of chronic renal failure: Starting dose: 50–100 units/kg three times weekly, IV for dialysis patients and IV or subcutaneously for nondialysis patients. Reduce dose if Hct increases > 4 points in any 2-wk period. Increase dose if Hct does not increase by 5–6 points after 8 wk of therapy. For maintenance dose, individualize based on Hct, generally 25 units/kg three times weekly. Target Hct range 30%–36%.
· Treatment of anemia in HIV-infected patients on AZT therapy: For patients receiving AZT dose < 4,200 mg/wk with serum erythropoietin levels < 500 mU/mL, use 100 units/kg IV or subcutaneously three times/wk for 8 wk; when desired response is achieved, titrate dose to maintain Hct with lowest possible dose.
· Treatment of anemia in cancer patients on chemotherapy (Procrit only): 150 units/kg subcutaneously three times/wk; after 8 wk, can be increased to 300 units/kg.
· Reduction of allogenic blood transfusions in surgery: 300 units/kg/day subcutaneously for 10 days before surgery, on day of surgery, and 4 days after surgery. Ensure Hgb is > 10–< 13 g/dL
PEDIATRIC PATIENTS 1 MO–16 YR
· Chronic renal failure on dialysis: 50 mcg/kg IV or subcutaneously three times/wk.
· Anemia of prematurity: 25–100 units/kg/dose three times/wk.
Metabolism: Serum; T1/2: 4–13 hr
Distribution: Crosses placenta; enters breast milk
Preparation: As provided; no additional preparation. Enter vial only once; do not shake vial. Discard any unused solution. Refrigerate.
Infusion: Administer by direct IV injection or into tubing of running IV.
Incompatibilities: Do not mix with any other drug solution.
· CNS: Headache, arthralgias, fatigue, asthenia, dizziness, seizure, CVA, TIA
· CV: Hypertension, edema, chest pain
· GI: Nausea, vomiting, diarrhea
· Other: Clotting of access line
· History: Uncontrolled hypertension, hypersensitivity to mammalian cell-derived products or to albumin human, lactation
· Physical: Reflexes, affect; BP, P; urinary output, renal function; renal function tests; CBC, Hct, iron levels, electrolytes
· Confirm chronic, renal nature of anemia; not intended as a treatment of severe anemia or substitute for emergency transfusion.
· Gently mix; do not shake, shaking may denature the glycoprotein. Use only one dose per vial; do not reenter the vial. Discard unused portions.
· Do not give with any other drug solution.
· Administer dose three times per week. If administered independent of dialysis, administer into venous access line. If patient is not on dialysis, administer IV or subcutaneously.
· Monitor access lines for signs of clotting.
· Arrange for Hct reading before administration of each dose to determine dosage. If patient fails to respond within 8 wk of therapy, evaluate patient for other etiologies of the problem.
· Evaluate iron stores prior to and periodically during therapy. Supplemental iron may need to be ordered.
· Institute seizure precautions.
· Drug must be given three times per week and can only be given intravenously, subcutaneously, or into a dialysis access line. Prepare a schedule of administration dates.
· Keep appointments for blood tests necessary to determine the effects of the drug on your blood count and to determine dosage.
· Maintain all of the usual activities and restrictions that apply to your chronic renal failure. If this becomes difficult, consult with your health care provider.
· You may experience these side effects: Dizziness, headache, seizures (avoid driving or performing hazardous tasks); fatigue, joint pain (may be medicated); nausea, vomiting, diarrhea (proper nutrition is important).
· Report difficulty breathing, numbness or tingling, chest pain, seizures, severe headache.
Adverse effects in Italic are most common; those in Bold are life-threatening.