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Pharmacologic class: Recombinant human erythropoietin
Therapeutic class: Biological response modifier
Pregnancy risk category C
Binds to erythropoietin, stimulating mitotic activity of erythroid progenitor cells in bone marrow and causing release of reticulocytes from bone marrow into bloodstream, where they become mature RBCs
Injection: 2,000 units/ml, 3,000 units/ml, 4,000 units/ml, 10,000 units/ml; 10,000 units/ml and 20,000 units/ml in multidose vials
Indications and dosages
➣ Anemia associated with chronic kidney disease (CKD) in patients on dialysis or not on dialysis
Adults: Initially, 50 to 100 units/kg I.V. or subcutaneously three times weekly. Don't increase dosage more frequently than once q 4 weeks. May decrease dosage more frequently but avoid frequent dosage adjustments.
➣ Anemia in children with chronic CKD who are on dialysis
Children ages 1 month to 16 years: Initially, 50 units/kg I.V. or subcutaneously three times weekly. Don't increase dosage more frequently than once q 4 weeks. May decrease dosage more frequently but avoid frequent dosage adjustments.
➣ Anemia caused by zidovudine therapy in patients with human immunodeficiency virus infection
Adults: 100 units/kg I.V. or subcutaneously three times weekly for 8 weeks or until hematocrit level is adequate. If desired response isn't reached after 8 weeks, dosage may be increased by 50 to 100 units/kg I.V. or subcutaneously three times weekly; after 4 to 8 weeks, dosage may be further increased, as prescribed, to a maximum dosage of 300 units/kg I.V. or subcutaneously three times weekly.
➣ Anemia due to effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
Adults: 150 units/kg subcutaneously three times weekly until completion of a chemotherapy course, or 40,000 units subcutaneously weekly until completion of a chemotherapy course Children ages 5 to 18: 600 units/kg I.V. weekly until completion of a chemotherapy course
➣ To reduce need for blood transfusion in surgical patients
Adults: 300 units/kg subcutaneously daily for 10 days before surgery, on day of surgery, and for 4 days after surgery; or 600 units/kg subcutaneously weekly starting 3 weeks before surgery, followed by additional dose on day of surgery
• Serious allergic reactions
• Uncontrolled hypertension
• Pure red cell aplasia that begins after treatment
• Use of multidose vials in neonates, infants, and pregnant and breastfeeding patients
Use cautiously in:
• renal insufficiency, CV disease
• pregnant or breastfeeding patients
• children younger than age 1 month (safety and efficacy not established).
• Don't shake drug and don't use if it has been shaken or frozen.
• Don't dilute or mix with other drug solutions. However, preservative-free epoetin alfa from single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at time of administration; keep in mind that risks are associated with benzyl alcohol use in some patients.
• Don't reenter preservative-free vials.
• For patients with CKD on dialysis, start drug when hemoglobin level is less than 10 g/dl. If hemoglobin level approaches or exceeds 11 g/dl, reduce dosage or interrupt dosing.
• For patients with CKD not on dialysis, consider starting drug only when hemoglobin level is less than 10 g/dl and the following considerations apply: Rate of hemoglobin decline indicates the likelihood of requiring an RBC transfusion and reducing the risk of alloimmunization or other RBC transfusion-related risks is a goal. If hemoglobin level exceeds 10 g/dl, reduce dosage or interrupt dosing and use lowest dosage sufficient to reduce the need for RBC transfusions.
• Be aware that in patients undergoing surgery, deep venous thrombosis prophylaxis is strongly recommended during epoetin alfa therapy.
• For I.V. use, give single dose by direct I.V. injection over at least 1 minute, and follow with saline flush.
• If patient is on hemodialysis, administer drug into venous return line of dialysis tubing after patient completes dialysis session.
• Know that supplemental iron may be needed to support erythropoiesis and avoid iron depletion.
☞ Avoid using multidose vials in neonates, infants, and pregnant and breastfeeding patients because of benzyl alcohol content, which has been associated with serious adverse events and death, including "gasping syndrome."
CNS: headache, paresthesia, fatigue, dizziness, asthenia, seizures
CV: hypertension, increased clotting of arteriovenous grafts
GI: nausea, vomiting, diarrhea
Metabolic: hyperuricemia, hyperphosphatemia, hyperkalemia
Musculoskeletal: joint pain
Respiratory: cough, dyspnea
Skin: rash, urticaria
Other: fever, edema, injection site pain
Drug-diagnostic tests. Blood urea nitrogen, creatinine, phosphate, potassium, uric acid: increased levels
• Monitor vital signs and cardiovascular status, especially for hypertension and edema.
• Assess arteriovenous graft for patency, because drug may increase clotting at graft.
• Monitor electrolyte and uric acid levels. Watch closely for hyperuricemia, hyperkalemia, and hyperphosphatemia.
• Check temperature for fever.
• Monitor neurologic status for signs and symptoms of impending seizure.
• Evaluate nutritional status and hydration in light of GI adverse effects.
• Tell patient who will self-administer drug to follow exact directions for injection and needle disposal.
☞ Instruct patient to monitor weight and blood pressure regularly and to immediately report hypertension, sudden weight gain, or swelling.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, motor skills, and alertness.
• Tell patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Advise female patient to discuss pregnancy or breastfeeding with prescriber before starting drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.