aranesp to retacrit conversion

Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. HrsW-D/tCPs. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. transfusions, and iron studies. Do not increase the dose more frequently than once every 4 weeks. All Rights Reserved. %PDF-1.5 If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. <>stream Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. alfa is as well tolerated and efficacious as epoetin alfa even when epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary to treat anemia associated with myelodysplastic syndromes when the following criteria are met: 2, 3,8,9,32,46 . Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. alfa (Aranesp; Amgen) to be therapeutic equivalent products Epoetin alfa. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions. Epub 2014 Jan 31. Evaluate the iron status in all patients before and during treatment. 1022 0 obj Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. and approved an automatic therapeutic interchange to darbepoetin Before sharing sensitive information, make sure you're on a federal government site. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Epub 2014 Aug 14. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. In pediatric patients, Mircera is administered by intravenous injection only (2.2). The optimal timing and duration of growth factor stimulation has not been determined. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? . and transmitted securely. 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. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. *Z?PkIV/X8$yN7.7 2022Pfizer Inc. All rights reserved. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. 7/2021: added Epogen (nonformulary). Methods: If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). 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)]. 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. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. M(aOf}c^gw+&=s=O{+h5ACmVA;8*=vSO`8dmD}a"'3L DMr7GwG 3\\q'z .MreQlX`DWxxxnU@!TUrTng_wAMc`0N[P Si)i+j(1A%@xaB&Zx03\'O.h` &!T6. 0*ET*LQjH!z!6G OsI`~ 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Careers. HHS Vulnerability Disclosure, Help A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). A total of These are recommended The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned 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. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. A single hemoglobin excursion may not require a dosing change. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Discontinue RETACRIT therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected, RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women. k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC of darbepoetin alfa, the half-life is ~49 hours (a similar half-life Darbepoetin alfa, although several fold more biologically Drug class: recombinant human erythropoietins, Aranesp (Darbepoetin Alfa Prefilled Syringes), Anemia Associated with Chronic Renal Failure, If hemoglobin exceeds a level needed to avoid RBC transfusion, If hemoglobin increases by less than 1 g/dL. affinity has no or little clinical relevance. Accessibility 2 0 obj These are recommended doses. IV 0 MeSH The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. official website and that any information you provide is encrypted Severe chronic neutropenia: Congenital: 6 mcg/kg twice daily Idiopathic/cyclic: 5 mcg/kg/day, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9222, Supplied: Injection, solution [preservative free]: 300 mcg/mL (1 mL, 1.6 mL) [vial; contains sodium 0.035 mg/mL and sorbitol], Injection, solution [preservative free]: 600 mcg/mL (0.5 mL, 0.8 mL) [prefilled Singleject syringe; contains sodium 0.035 mg/mL and sorbitol], Drug UPDATES: ZARXIO - filgrastim-sndz injection [Drug information / PDF] Click link for the latest monographDosing: Click (+) next to Dosage and Administration section (drug info link). Both drugs are costly: January 2003 prices posted by Medicare put reimbursement rates at $12.69 per 1000 units of Procrit (translating to about $534.32 for the Average Wholesale Price [AWP] for a once-a-week dose of 40,000 units) and $23.69 per 5 micrograms of Aranesp (about $994.98 for the AWP for a 3 mcg/kg dose every other week). as well). Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Safety and Efficacy: Currently available data indicate that darbepoetin A target Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Serious allergic reactions to OMONTYS. <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disease should prescribe Neulasta for such patients, and only after careful consideration of the potential risks and benefits. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Do not dilute. of Pharmacy Drug Information Center (216-444-6456, option #1). PMC Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. at the Cleveland Clinic Health System (CCHS) reviewing the use of endobj Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU). alfa may be administered as frequently as once every 3 or 4 weeks. 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). For recommended dose equivalency, The FDAs approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. An official website of the United States government. The IV route is recommended for patients on hemodialysis, For adult patients with CKD not on dialysis, The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC, The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly IV or SC, Recommended dosing for patients with HIV treated with zidovudine, The recommended starting dose in adults is 100 Units/kg as an IV or SC injection 3 times per week, If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid red blood cell (RBC) transfusions or 300 Units/kg, Recommended starting dose for adults and children undergoing cancer chemotherapy*, 150 Units/kg SC 3 times per week until completion of a chemotherapy course, or, 40,000 Units SC weekly until completion of a chemotherapy course, 600 Units/kg IV weekly until completion of a chemotherapy course.

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