EPOGEN MULTIDOSE Rx

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EPOGEN MULTIDOSE

Anemias
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Generic Name and Formulations:

Epoetin alfa 10000 Units, 20000 Units; per mL; soln for IV or SC inj; contains albumin (human) and benzyl alcohol.

Company:

Amgen, Inc.

Select therapeutic use:

Indications for EPOGEN MULTIDOSE:

Anemia in chronic kidney disease (CKD). Anemia related to zidovudine in HIV-infected patients. Chemotherapy-induced anemia in patients with non-myeloid malignancies with a minimum of two additional months of planned chemotherapy upon initiation. To reduce need for allogeneic blood transfusions in anemic (hemoglobin >10 to ≤13g/dL) patients scheduled for elective, noncardiac, nonvascular surgery.

Adult:

Individualize (see full labeling for titration). CKD: initially 50–100 Units/kg 3 times per week IV (dialysis or non dialysis) or SC (non dialysis); usual max (non dialysis) 150 Units/kg 3 times per week; (dialysis) 200 Units/kg 3 times per week; target hemoglobin 10–12g/dL. Zidovudine-treated HIV patients: if serum erythropoietin ≤500 mUnits/mL and zidovudine dose ≤4.2 g/wk: initially 100 Units/kg IV or SC 3 times per week for 8 weeks; usual max 300 Units/kg 3 times per week. Chemotherapy-induced: initially 150 Units/kg SC 3 times per week; may increase to 300 Units/kg 3 times per week after 8 weeks. Or, initially 40000 Units SC once weekly; may increase to 60000 Units once weekly after 4 weeks. Discontinue after completion of chemotherapy course. Surgery: If ≥21 days until surgery: 600 Units/kg once weekly SC at 21, 14 and 7 days before surgery, and a 4th dose on day of surgery. If <21 days until surgery: 300 Units/kg per day SC for 10 days before, on day of, and for 4 days after surgery. All: adjust dose to maintain the lowest hemoglobin level (target max 12g/dL) sufficient to avoid red blood cell transfusion; see full labeling.

Children:

Individualize (see full labeling for monitoring). CKD (dialysis): <1 month: not recommended. ≥1 month: initially 50 Units/kg three times per week IV or SC. Target hemoglobin: 10–12g/dL. Chemotherapy-induced: ≥5yrs: 600 Units/kg IV weekly (max 40,000 Units); may increase to 900 Units/kg IV weekly (max 60,000 Units) after 4 weeks. Discontinue after completion of chemotherapy course. Other uses: see full labeling.

Contraindications:

Uncontrolled hypertension. Pure red cell aplasia that begins after Epogen or other erythropoietin drug therapy. Also with Multidose: neonates and infants. Pregnancy. Nursing mothers.

Warnings/Precautions:

See full labeling. Increased mortality, MI, stroke, and thromboembolism. Coexistent cardiovascular disease and stroke. Evaluate serum iron, ferritin, transferrin saturation before therapy; all patients will need iron supplementation. Monitor hemoglobin (measure twice weekly for 2–6 weeks after any dosage adjustment; reduce dose if hemoglobin increases >1g/dL in any 2-week period; withhold dose if hemoglobin exceeds 12g/dL), blood pressure, renal function, iron levels, clotting times, serum chemistry, CBC, and for premonitory neurological symptoms. Seizure disorders. Hematologic disorders. Hypertension (esp. in renal failure). Porphyria. Concurrent infection, inflammation, increased zidovudine dose, or other factors may reduce effectiveness. Possible risk for viral disease and Creutzfeldt-Jakob disease transmission. Discontinue if severe skin reaction (eg, SJS, TEN) is suspected. Perisurgery: consider DVT prophylaxis. Consider other etiologies in treatment failures. Adjust anticoagulant dose in dialysis patients. Menses may resume. Neonates and infants (use single-dose vials). Pregnancy. Nursing mothers.

See Also:

EPOGEN

Pharmacological Class:

Erythropoietin (human, recombinant).

Adverse Reactions:

Iron deficiency, hypertension, headache, arthralgia, GI disturbances, edema, local reaction, rash (may be severe), paresthesia, dizziness, clotted vascular access (A-V shunt), pyrexia, respiratory congestion, seizures. Increased risk of death, cardiovascular or thrombotic events if hemoglobin >12g/dL. May stimulate tumor growth, shorten time to tumor progression or overall survival if hemoglobin ≥12g/dL. Children: also abdominal pain, upper respiratory infection, cough, pharyngitis, constipation.

How Supplied:

Single-use 1mL vials (all)—10; Multidose 2mL vials (10000 Units/mL)—10; Multidose 1mL vials (20000 Units/mL)—10