G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage. Last updated on Jan 20, 2023. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Discard unused portion of Aranesp in vials or prefilled syringes. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). In the near future, the Pharmacy and Therapeutics Conversion of IV to SC EPO: a. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Do Not Copy, Distribute or otherwise Disseminate without express permission. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee in two ways: 1) Hgb levels > 12 g/dL or 2) an increase IL-11 has also been shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. group. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. half-life of 8.5 hours. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. 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. RETACRIT safely and effectively. Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy of Pharmacy Drug Information Center (216-444-6456, option #1). Martnez Castelao A, Reyes A, Valds F, Otero A, Lpez de Novales E, Pallard L, Tabernero JM, Hernndez Jaras J, Llads F. Brunkhorst R, Bommer J, Braun J, Haag-Weber M, Gill C, Wagner J, Wagener T; German Aranesp Study Group. or 100 mcg SC once weekly. Beneficial dose conversion after switching from higher doses of shorter-acting erythropoiesis-stimulating agents to C.E.R.A in CKD patients in clinical practice: MINERVA Study. 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. W bO? Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Dr. Gerald Diaz @GeraldMD. Copyright 1993-2021 Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Accessibility 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. 33 Dose. This site needs JavaScript to work properly. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. 1 0 obj Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit Do not increase the dose more frequently than once every 4 weeks. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Nephrol Dial Transplant. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Switch from epoetin to darbepoetin alfa in hemodialysis: dose In chronic kidney disease If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Initiate Aranesp in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx Avoid frequent dose adjustments. Pussell BA, Walker R; Australian Renal Anaemia Group. Switching Between Epoetins: A Practice in Support of Biosimilar Use conversion factor of 1 mcg:220 units Aranesp:EPO. The products discussed in this site may have different product labeling in different countries. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. These adverse reactions included myocardial infarction and stroke, In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). Bethesda, MD 20894, Web Policies The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. More specifically, 23 patients in the epoetin alfa group : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. patients and 55 darbepoetin alfa patients. chemotherapy. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. If patient does not respond, a response to higher doses is unlikely. Referrals to independent nonprofitpatient assistance programs. A local search option of this data can be found here. (CKD) patients, darbepoetin alfa administered intravenously has The safety and effectiveness of Neumega have not been established in pediatric patients. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned Increase dose by 50-100 units/kg 3 times/week if response is not satisfactory in terms of reducing transfusion requirements or increasing hemoglobin after 8 weeks of therapy. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. affinity has no or little clinical relevance. Round the dose to the nearest treatment tier. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Aranesp Dosing and Conversion Brochure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance This site is intended only for U.S. healthcare professionals. alfa- and darbepoetin alfa-treated patients, respectively. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. doses. Before An official website of the United States government, : Do not dilute. Adjust dose as follows to achieve and maintain a target hemoglobin: Inadequate response: Hemoglobin increases <1 g/dL after 6 weeks of therapy: Increase dose to 4.5 mcg/kg. alfa and 200 mcg every 2 weeks for darbepoetin alfa. 1121 0 obj Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Update Index. Internal Data: A retrospective drug use evaluation (DUE) was conducted Aranesp | European Medicines Agency Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Mean baseline Hgb levels Do not shake. Pharmacotherapy and 24 patients in the darbepoetin alfa group reached the targeted this interchange program should be directed to the CCF Department Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis, Adverse reactions in 5% of epoetin alfa-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation. What is the practical conversion dose when changing from epoetin alfa Decreases in dose can occur more frequently. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disease should prescribe Neulasta for such patients, and only after careful consideration of the potential risks and benefits. May 15, 2018. The .gov means its official. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Similar to endogenous A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. Nephrology (Carlton). Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . If hemoglobin increases greater than 1 g/dL in any 2-week period or, If hemoglobin reaches a level needed to avoid RBC transfusion, Withhold dose until hemoglobin approaches a level where RBC transfusions may be required, Reinitiate at a dose 40% below the previous dose, If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy, Following completion of a chemotherapy course. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). IV Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. alfa for chronic anemia of cancer and chemotherapy-induced anemia Monitor platelets and hematocrit regularly. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Unauthorized use of these marks is strictly prohibited. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week Mechanism of Action: Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation differentiation commitment and some end-cell functional activation. Epub 2005 Dec 6. 8600 Rockville Pike PDF Food and Drug Administration Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. 4 x previous weekly epoetin alfa dose (Units)/125. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. epoetin alfa and darbepoetin alfa for the management of CIA. INDICATIONS AND USAGE Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. INDICATIONS AND USAGE: 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZARXIO is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1)].
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