Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first epoetin alfa biosimilar for the treatment of anemia, FDA: Office of Hematology and Oncology Products. The recommended starting dose for pediatric patients (less than 18 years) is 0.45 mcg/kg body weight administered as a single subcutaneous or intravenous injection once weekly; patients not receiving dialysis may be initiated at a dose of 0.75 mcg/kg once every 2 weeks. 2. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Federal government websites often end in .gov or .mil. In addition, at this time, this interchange program does not affect Generic name: DARBEPOETIN ALFA 10ug in 0.4mL The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic . 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Aranesp Dosing and Conversion Brochure. CHO chains) has a 3-fold increase in half-life when compared to Follow the Oncology Center of Excellence on Twitter @FDAOncology. Aranesp is the only long-acting erythropoiesis-stimulating agent (ESA) approved for both once weekly (QW) and once every three weeks (Q3W) dosing 1, 2 Aranesp dosing options of QW or Q3W may allow for synchronization with common myelosuppressive chemotherapy regimens. These are recommended doses. In order to be included in the DUE, The safety and effectiveness of Neumega have not been established in pediatric patients. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. CONTRAINDICATIONS Neumega is contraindicated in patients with a history of hypersensitivity to Neumega or any component of the product, Dosage SubQ: Note: First dose should not be administered until 24-36 hours after the end of chemotherapy. in Hgb of 2 g/dL from baseline. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, and 40,000 Units of epoetin alfa-epbx injection contains 0.5 mg of phenylalanine. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. An official website of the United States government, : of patients receiving transfusions was similar between the groups, Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves Retacrit as a biosimilar to Epogen/Procrit, Drug Information Soundcast in Clinical Oncology. The number chemotherapy.
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