half-life of 8.5 hours. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Round the dose to the nearest treatment tier. Pussell BA, Walker R; Australian Renal Anaemia Group. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. An official website of the United States government. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. PDF Home Dialysis Programs Standing Orders - Erythropoietin What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Based on data from this CCHS DUE, darbepoetin alfa and Epub 2014 Aug 14. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. <> The information provided is for educational purposes only. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase Conversion from Another ESA: dosed once every 4 weeks based on total Bone marrow transplantation: 5-10 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of neutropenia; recommended steps based on neutrophil response: When ANC >1000/mm3 for 3 consecutive days: Reduce filgrastim dose to 5 mcg/kg/day If ANC remains >1000/mm3 for 3 more consecutive days: Discontinue filgrastim If ANC decreases to <1000/mm3 : Resume at 5 mcg/kg/day If ANC decreases <1000/mm3 during the 5 mcg/kg/day dose, increase filgrastim to 10 mcg/kg/day and follow the above steps. Before sharing sensitive information, make sure you're on a federal government site. In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. Study of Transplant Related Anemia Treated With Aranesp (STRATA VII, No. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Pharmacotherapy Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or RETACRIT is contraindicated in patients with: RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM, INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER, LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT, RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE, ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE, ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER, ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION, Recommended dosing for adults and children with chronic kidney disease (CKD), The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously (IV) or subcutaneously (SC). PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Discard unused portion of Aranesp in vials or prefilled syringes. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Accessibility Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed Monitor platelets and hematocrit regularly. In CKD, for subcutaneous (SC) administration RETACRIT safely and effectively. 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. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. 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. Based on market share Protect vials and prefilled syringes from light. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Pfizer for Professionals 1-800-505-4426 PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy at the Cleveland Clinic Health System (CCHS) reviewing the use of The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. before initiating Aranesp. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. HrsW-D/tCPs. Contributed by. 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy ZARXIO is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)]. The .gov means its official.Federal government websites often end in .gov or .mil. To report an adverse event, please call 1-800-438-1985. transfusions, and iron studies. Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 microg/week (P = 0.02). Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Committee will be exploring other patient populations for this levels, and to improve quality of life. Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL of the molecule is a more important determinant of potency and receptor Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. More specifically, 23 patients in the epoetin alfa group If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. May 15, 2018. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. For recommended dose equivalency, <>stream Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. interchange, such as patients with chronic renal failure (CRF). Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. 8600 Rockville Pike 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). 2022Pfizer Inc. All rights reserved. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Wien Med Wochenschr. 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. It is used in two groups of patients: adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly); adults who are receiving chemotherapy for nonmyeloid cancer (cancer not originating in . No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. alfa-treated patients, respectively. Epogen (Amgen), another brand name for epoetin Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Use caution in patients with coexistent cardiovascular disease and stroke. Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria . Approved by FMOLHS P&T. . Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Following initiation and titration of epoetin alfa, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving RETACRIT, Appropriately control hypertension prior to initiation of and during treatment with RETACRIT.