All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. eCollection 2017. Similar to endogenous In CKD, for subcutaneous (SC) administration WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. 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. Adult Respiratory Distress Syndrome (ARDS) Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. If there are still air bubbles, repeat the steps above to remove them. For recommended dose equivalency, For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). Aranesp | European Medicines Agency Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Woodland AL, Murphy SW, Curtis BM, Barrett BJ. %PDF-1.6 % May 15, 2018. *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. . e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Avoid frequent dose adjustments. Studies of erythropoietin therapy 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). Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. In cancer patients, erythropoietic agents, including Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Neulasta should not be used for PBPC mobilization. The .gov means its official.Federal government websites often end in .gov or .mil. epoetin alfa produce similar Hgb levels in patients with CIA. . Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. Retacrit has been approved as a biosimilar, not as an interchangeable product. %PDF-1.5 Maintain the route of administration (intravenous or subcutaneous injection). Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 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). Epub 2005 Dec 6. Epub 2014 Jan 31. Do Not Copy, Distribute or otherwise Disseminate without express permission. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. This site needs JavaScript to work properly. Use caution in patients with coexistent cardiovascular disease and stroke. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. Amgen Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Switching Between Epoetins: A Practice in Support of Biosimilar Use MeSH Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. (CIA) for both outpatients and inpatients. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. RETACRIT safely and effectively. Please enable it to take advantage of the complete set of features! b. Refer to Aranesp package insert for pediatric dosing conversion. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. of Pharmacy Drug Information Center (216-444-6456, option #1). National Library of Medicine U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN $l-FRW+>U0pPhRc/N R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" Epub 2004 Feb 19. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). Serious allergic reactions to OMONTYS. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa both groups iron studies were not conducted routinely. <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna The recommended starting Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. 2 0 obj alfa for chronic anemia of cancer and chemotherapy-induced anemia The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Decreases in dose can occur more frequently. see Tables A and B (below). Use caution in patients with coexistent cardiovascular disease and stroke. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Results: Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. W bO? 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. Based on the patient's response, darbepoetin Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). Excessive response: Hemoglobin increases >1 g/dL in any 2-week period: Decrease dose Hemoglobin increases and approaches the target value of 12 g/dL: Decrease weekly dosage by ~25%. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. 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. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of Aranesp or whether the patient would benefit from a different Aranesp presentation. Careers. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Drug class: Recombinant human erythropoietins. Questions regarding Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. administered less frequently. It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products, said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDAs Center for Drug Evaluation and Research. 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. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. alfa. and transmitted securely. The number 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. therapy. most common dosing regimens are 40,000 units weekly for epoetin The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Dosage form: injection, solution Monitor platelets and hematocrit regularly. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. The site is secure. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. Both Retacrit and Procrit are approved for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned The dose should be titrated to meet and In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Overall, in 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. 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. RETACRIT Dosage and Administration (epoetin alfa-epbx) Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. arena for dosing, dosing interval, hemoglobin levels, number of Based on data from this CCHS DUE, darbepoetin alfa and Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). as well). response rates ranging from ~60% to 85%. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. 8600 Rockville Pike JKn&,&LzN Response rates are defined The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and U.S.-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). A target Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. endobj Do not mix with other drug solutions. Wien Med Wochenschr. Nephrology (Carlton). 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)]. Darbepoetin alfa, although several fold more biologically These are recommended When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of . 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. 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 . Vol. 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. 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 . 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. 3 0 obj hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) What is the difference between Retacrit and Procrit? - Drugs.com Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub 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. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Conversion of IV to SC EPO: a. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Immediately and permanently discontinue RETACRIT and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs, Blistering and skin exfoliation reactions, including erythema multiforme and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported in patients treated with ESAs (including epoetin alfa) in the postmarketing setting. adjustments may be required. alfa-treated patients, respectively. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 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. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 335 0 obj <>stream Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) of endogenous erythropoietin may be impaired in patients receiving Protect vials and prefilled syringes from light. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). % Pharmacotherapy Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine.