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Retacrit Generic Name & Formulations
Legal Class
Rx
General Description
Epoetin alfa-epbx 2000 Units, 3000 Units, 4000 Units, 10000 Units, 20000 Units, 40000 Units; per mL; soln for IV or SC inj.
Pharmacological Class
Erythropoiesis stimulating protein.
How Supplied
Single-dose vials (2000 Units/mL, 3000 Units/mL, 4000 Units/mL, 10000 Units/mL)—10; (40000 Units/mL)—4, 10; Multiple-dose vials (20000 Units/mL, 20000 Units/2mL)—4, 10
Manufacturer
Generic Availability
NO
Retacrit Indications
Indications
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.
Limitations of Use
Not shown to improve quality of life, fatigue, or patient well-being. Not indicated for: cancer patients receiving hormones, biologics, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy; cancer patients receiving chemotherapy if anticipating cure or if anemia can be managed by transfusion; patients scheduled for surgery who are willing to donate autologous blood; patients undergoing cardiac or vascular surgery; as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Retacrit Dosage and Administration
Adult
Individualize (see full labeling for titration). CKD: initially 50–100 Units/kg 3 times weekly IV (dialysis and non dialysis) or SC (non dialysis). Zidovudine-treated HIV patients: initially 100 Units/kg IV or SC 3 times weekly. Chemotherapy-induced: initially 150 Units/kg SC 3 times weekly; may increase to 300 Units/kg 3 times weekly after 4 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: 300 Units/kg SC daily for 15 days total (give daily for 10 days before surgery, on the day of, and for 4 days after surgery). Or, 600 Units/kg SC at 21, 14, and 7 days before surgery and on the day of surgery. All: adjust dose to maintain the lowest hemoglobin level sufficient to avoid red blood cell transfusion; see full labeling.
Children
Individualize (see full labeling for monitoring). CKD: <1 month: not established. ≥1 month: 50 Units/kg 3 times weekly IV or SC. Target hemoglobin: 10–12g/dL. Chemotherapy-induced: <5yrs: not established. 5–18yrs: initially 600 Units/kg IV weekly; may increase to 900 Units/kg IV weekly (max 60000 Units) after 4 weeks. Discontinue after completion of chemotherapy course.
Retacrit Contraindications
Contraindications
Uncontrolled hypertension. Pure red cell aplasia (PRCA) that begins after treatment with Retacrit or other erythropoietin protein drugs. Use of multiple-dose vials (contain benzyl alcohol) in neonates, infants, pregnant and lactating women.
Retacrit Boxed Warnings
Boxed Warning
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
Retacrit Warnings/Precautions
Warnings/Precautions
See full labeling. Increased mortality, MI, stroke, and thromboembolism. Coexistent cardiovascular disease and stroke. Increased risk of tumor progression or recurrence in those with cancer. Perisurgery: consider DVT prophylaxis. Evaluate serum iron, ferritin, transferrin saturation before therapy; most patients will need iron supplementation. Monitor hemoglobin (at least weekly until level is stable then at least monthly; reduce dose if hemoglobin increases >1g/dL in any 2-week period; interrupt dose as needed), blood pressure, renal function, iron levels, clotting times, CBC, and for premonitory neurological symptoms. Seizure disorders. Hematologic disorders; permanently discontinue if PRCA develops; do not switch to other ESAs. Hypertension (esp. in renal failure). Concurrent infection, inflammation, or other factors may reduce effectiveness. Discontinue if severe cutaneous reactions (eg, SJS, TEN) suspected or serious allergic reactions occur. Phenylketonuria (single-dose vials contain phenylalanine). Consider other etiologies in treatment failures. Adjust anticoagulant dose in dialysis patients. Pregnancy. Nursing mothers.
Retacrit Pharmacokinetics
See Literature
Retacrit Interactions
Not Applicable
Retacrit Adverse Reactions
Adverse Reactions
Hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, upper respiratory tract infection, cough, rash, inj site irritation/pain, nausea, vomiting, myalgia, stomatitis, weight decrease, leukopenia, bone pain, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, thrombosis, pruritus, chills, DVT; seizures, PRCA, serious allergic reactions.
Retacrit Clinical Trials
See Literature
Retacrit Note
Not Applicable
Retacrit Patient Counseling
See Literature
