When therapy with RETACRITis needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy, In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure, In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion, In patients scheduled for surgery who are willing to donate autologous blood, In patients undergoing cardiac or vascular surgery, As a substitute for RBC transfusions in patients who require immediate correction of anemia, Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs, Serious allergic reactions to RETACRIT or other epoetin alfa products, Neonates, infants, pregnant women, and lactating women. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. Epub 2005 Dec 6. 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)]. Overall, in Conversion from Another ESA: dosed once every 4 weeks based on total Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 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). The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. Existing patients on IV EPO, change to subcutaneous EPO using the . Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. (PDF) Conversion from epoetin beta to darbepoetin: What is the DOSAGE FORMS AND STRENGTHS Dosage Form Strengths Single use vials (preservative-free) 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Single use pre-filled syringes (preservative-free) 1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Multiple use vials (with preservative) 10 mg/mL and 20 mg/2 mL, CONTRAINDICATIONS: Uncontrolled hypertension. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). 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. 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). This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Do not re-enter vial. or 100 mcg SC once weekly. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. Maintain the route of administration (intravenous or subcutaneous injection). Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. of endogenous erythropoietin may be impaired in patients receiving <> 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. Accessibility Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. 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. HHS Vulnerability Disclosure, Help Epogen (Amgen), another brand name for epoetin Mean baseline Hgb levels for at least 3 weeks between July 2002 and July 2003. Darbepoetin alfa (Aranesp) Place of Service Hospital Administration The site is secure. 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. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Evaluate other causes of anemia. of darbepoetin administered SC has been shown in cancer patients The .gov means its official.Federal government websites often end in .gov or .mil. On May 15, 2018, the Food and Drug Administration approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Discard unused portion of Aranesp in vials or prefilled syringes. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance Epub 2014 Jan 31. 4. FOIA alfa- and darbepoetin alfa-treated patients, respectively. response rates ranging from ~60% to 85%. and transmitted securely. Retacrit has been approved as a biosimilar, not as an interchangeable product. PMC If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first epoetin alfa biosimilar for the treatment of anemia, FDA: Office of Hematology and Oncology Products. For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp dose further is unlikely to improve response and may increase risks. Study of Transplant Related Anemia Treated With Aranesp (STRATA <>stream endstream endobj 336 0 obj <>stream The products discussed in this site may have different product labeling in different countries. 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. Chronic Kidney Disease: 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. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. 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. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx National Library of Medicine Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. Amgen 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). When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Switching Between Epoetins: A Practice in Support of Biosimilar Use Overall, in both groups iron studies were not conducted routinely. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. Do not shake. 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. 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`~ and 24 patients in the darbepoetin alfa group reached the targeted Aranesp Dosage Guide - Drugs.com What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? May 15, 2018. active than epoetin alfa, paradoxically was found to have less affinity This site is intended for U.S. healthcare professionals. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. (CIA) for both outpatients and inpatients. <>/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 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. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. However, this may result in the over treatment of uraemic anaemia. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. 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. half-life of 8.5 hours. epoetin alfa and darbepoetin alfa, have been shown to decrease the When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. 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). Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). . PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks and iron stores are adequate: Increase by ~25% of the previous dose; increases should not be made more frequently than once monthly. Do not dilute. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . 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. The https:// ensures that you are connecting to the If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) eCollection 2017. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. In the event that ARDS occurs, Neulasta should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition. 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. hemoglobin of > 12 g/dL was reached in 47 patients (41%) A total of What is the difference between Retacrit and Procrit? - Drugs.com In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. 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%. Internal Data: A retrospective drug use evaluation (DUE) was conducted Before prescribing RETACRIT single-dose vials to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including RETACRIT, Patients may require adjustments in their dialysis prescriptions after initiation of RETACRIT. therapy. In chronic kidney disease 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. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Bethesda, MD 20894, Web Policies 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. dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ Vu],Ne,z8yT&6Qb6b=bk?+e/d`yo;~B#"z*wd j23#M]\"LFEB(hHQlD5h*}TJwlL{A Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Initial U.S. Approval: 2018 . Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency, For lack or loss of hemoglobin response to RETACRIT, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding). Dose adjustment: If response is not satisfactory after a sufficient period of evaluation (8 weeks of 3 times/week and 4 weeks of once weekly therapy), the dose may be increased every 4 weeks (or longer) up to 300 units/kg 3 times/week, or when dosed weekly, increased all at once to 60,000 units weekly. 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. <> Please enable it to take advantage of the complete set of features! Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 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" Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. administered less frequently. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. RETACRIT Instructions For Use (epoetin alfa-epbx) Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions, Epoetin alfa products, including RETACRIT, increase the risk of seizures in patients with CKD. 4. doses. 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. PDF Food and Drug Administration duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Last updated on Jan 20, 2023. PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. Aranesp (darbepoetin alfa) | Dosing Considerations PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa Drug class: Recombinant human erythropoietins. 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). Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Results: 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. Neulasta should not be used for PBPC mobilization. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Patients on Cancer Chemotherapy 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. Can J Kidney Health Dis. To report an adverse event, please call 1-800-438-1985. scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. alfa-treated patients, respectively. 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.

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