Epogen (epoetin alfa)

EPOGEN (epoetin alfa) – an erythropoiesis-stimulating agent (ESA)commonly used to treat anemia due to various conditions. Epogen stimulate erythropoiesis through the same mechanism as endogenous (naturally occurring) erythropoietin.

FDA approved uses: Epogen is indicated for the treatment of anemia due to:

Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. Zidovudine in HIV-infected patients (1.2). -The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Limitations of use: Epogen has not been shown to improve quality of life, fatigue, or patient wellbeing. Epogen is NOT indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. In patients scheduled for surgery who are willing to donate autologous blood. In patients undergoing cardiac or vascular surgery. As a substitute for RBC transfusions in patients who require immediate correction of anemia.

Available dosage forms: Single-dose vial: 2000, 3000, 4000, 10,000, and 40,000 Units/1 mL; Multidose vial containing benzyl alcohol: 20,000 Units/2 mL and 20,000 Units/1 mL.

Usual dosage: The manufacturer recommends the following doses for Epogen CKD Patients: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (children on dialysis). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis; Zidovudine-treated HIV-infected Patients: 100 Units/kg 3 times weekly; Cancer Patients on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (children ≥ 5 years); Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly.
Contraindications: Uncontrolled hypertension; Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs; Serious allergic reactions to Epogen; Use of the multi-dose vials in neonates, infants, pregnant women, and nursing mothers.

Special warnings: 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 target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions. Cancer – ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Epogen to patients with cancer. Use the lowest dose to avoid RBC transfusions. Use ESAs only for anemia from myelosuppressive chemotherapy. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue following the completion of a chemotherapy course. Perisurgery – Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended

Adverse reactions (side effects) of these medications: The most common side effects of Epogen include were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, upper respiratory tract infection, rash, injection site irritation, nausea, vomiting, myalgia, stomatitis, cough, weight decrease, leukopenia, bone pain, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, thrombosis, pruritus, injection site pain, chills and deep vein thrombosis.

Common drug interactions: The manufacturer has not formally conducted drug interaction studies with Epogen.

Special instructions for patients: Use Epogen exactly as prescribed by physician. It is important to undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions. Contact healthcare provider for new-onset neurologic symptoms or change in seizure frequency. Consult official Medication Guide for details on all of the warnings and precautions for using this medication.

Full prescribing information may be found at the manufacturer‘s official website Epogen.com or at the U.S. Food and Drug Administration’s website at Epogen Info at Drugs@FDA

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