aranesp to retacrit conversion

Dosage SubQ: Adolescents >45 kg and Adults: 6 mg once per chemotherapy cycle; do not administer in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy; do not use in patients, infants, children, and smaller adolescents weighing <45 kg. Serious allergic reactions to OMONTYS. 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 the near future, the Pharmacy and Therapeutics see Tables A and B (below). Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Questions regarding Dr. Gerald Diaz @GeraldMD. Patient treatments were converted from subcutaneous epoetin alfa to weekly, intravenous darbepoetin alfa at month 0, at a conversion dose of 200 units epoetin alfa to 1 microg darbepoetin. REASON FOR . The safety and effectiveness of Neumega have not been established in pediatric patients. Ann Pharmacother. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody dependent killing, and the increased expression of some functions associated with cell surface antigens). The optimal timing and duration of growth factor stimulation has not been determined. Mean baseline Hgb levels Select one or more newsletters to continue. 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. Based on market share What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Medically reviewed by Drugs.com. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. administered less frequently. alfa for chronic anemia of cancer and chemotherapy-induced anemia 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. 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. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Depending upon each patient's needs and response, dosage In addition, at this time, this interchange program does not affect Available for Android and iOS devices. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Follow the Oncology Center of Excellence on Twitter @FDAOncology. The .gov means its official. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! 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. contracts, darbepoetin alfa is less expensive than epoetin alfa. Studies of erythropoietin therapy The probability of switching between different epoetins was associated with the duration of treatment: about 15 % of users switched within 12 months and almost 25 % within 2 years of observation. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. 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. When therapy with RETACRIT is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In controlled clinical trials of patients with chronic kidney disease (CKD) comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), epoetin alfa increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups, Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. 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. %PDF-1.6 % All Rights Reserved. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. endstream endobj 336 0 obj <>stream Accessibility The site is secure. most common dosing regimens are 40,000 units weekly for epoetin After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL, 300 Units/kg 3 times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. Table 1. A target Aranesp is administered less frequently than epoetin alfa. Do not increase the dose more frequently than once every 4 weeks. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. Approved by FMOLHS P&T. . OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). RETACRIT single-dose vials contain phenylalanine, a component of aspartame. 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. Epub 2014 Aug 14. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r SN:]AW&g{auwi(D)Si'(EK 9P$a8d_R/au&tIk=[A'"Uh 5E~"{dC4dMs/*e?&Io}a\d05zVJ)~OL:MK'tiM>)r4zoBp`Vju`'78f4*q-PFa_,R2(r\?ASM^B6DT&s+IfUSqS6H5l~b)lMx:'j_sT[.q"ju g/8f5>tWw]}vAQNK0: st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c transfusions, and iron studies. Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. *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. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. More specifically, 23 patients in the epoetin alfa group [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. PMC Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. of endogenous erythropoietin may be impaired in patients receiving 335 0 obj <>stream For recommended dose equivalency, After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Discard unused portion of Aranesp in vials or prefilled syringes. Bethesda, MD 20894, Web Policies Training should aim to demonstrate to those patients and caregivers how to measure the dose of Aranesp, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for a prefilled syringe. Drug class: Recombinant human erythropoietins. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. RETACRIT safely and effectively. Please review the latest applicable package insert for additional information and possible updates. <> Aranesp Dosing and Conversion Brochure. Response rates are defined Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. The most frequent dosing regimens were 40,000 units weekly Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. 2022Pfizer Inc. All rights reserved. Evaluate other causes of anemia. FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicatedfor: Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. The products discussed in this site may have different product labeling in different countries. Clipboard, Search History, and several other advanced features are temporarily unavailable. Neulasta should not be used for PBPC mobilization. affinity has no or little clinical relevance. JKn&,&LzN Pussell BA, Walker R; Australian Renal Anaemia Group. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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 kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. The majority of reported events occurred upon initial exposure. Monitor platelets and hematocrit regularly. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g . The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. for the erythropoietin receptors, suggesting the slower clearance *Z?PkIV/X8$yN7.7 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). 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)]. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 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. The recommended starting Refer to Aranesp package insert for pediatric dosing conversion. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). Darbepoetin alfa (5 N-linked 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. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. ChronicKidney Disease: official website and that any information you provide is encrypted Bookshelf Decreases in dose can occur more frequently. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 . alfa is as well tolerated and efficacious as epoetin alfa even when Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. interchange, such as patients with chronic renal failure (CRF). The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefits.