contracts, darbepoetin alfa is less expensive than epoetin alfa. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. alfa (Aranesp; Amgen) to be therapeutic equivalent products Bethesda, MD 20894, Web Policies The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. endobj <> If there are still air bubbles, repeat the steps above to remove them. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. VII, No. 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. Referrals to independent nonprofitpatient assistance programs. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. In addition, Hgb levels were 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). <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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. An official website of the United States government. 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. 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. Depending upon each patient's needs and response, dosage The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. . government site. In addition, at this time, this interchange program does not affect To report an adverse event, please call 1-800-438-1985. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. 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)]. The implementation date for the interchange program is October 11, 2004. 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. 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. 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). Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. 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. Dosage form: injection, solution as well). this interchange program should be directed to the CCF Department Conversion from Another ESA: dosed once every 4 weeks based on total <>/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 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Product Information and Dosing | Mircera 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. Initial U.S. Approval: 2018 . If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. Evaluate the iron status in all patients before and during treatment. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Both Hb and ferritin concentrations remained within the target range, but darbepoetin dosages fell from 50.8 to 42.3 microg/week by month 3 (P = 0.02). Use the lowest dose of Aranesp necessary to avoid RBC transfusions. Call 1-888-4ASSIST to find out more. 7. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. 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 If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Safety and Efficacy: Currently available data indicate that darbepoetin Pharmacotherapy Update - Automatic Therapeutic Interchange Program Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. of patients receiving transfusions was similar between the groups, active than epoetin alfa, paradoxically was found to have less affinity PDF Home Dialysis Programs Standing Orders - Erythropoietin RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. <>stream ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. epoetin alfa produce similar Hgb levels in patients with CIA. MeSH Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Neulasta should not be used for PBPC mobilization. This site is intended for U.S. healthcare professionals. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? Epub 2014 Aug 14. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 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. JKn&,&LzN Dr. Gerald Diaz @GeraldMD. Scroll left to view table. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. May 15, 2018. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. If patient does not respond, a response to higher doses is unlikely. endobj 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. official website and that any information you provide is encrypted 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. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. and approved an automatic therapeutic interchange to darbepoetin 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. 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. Aranesp is the only long-acting erythropoiesis-stimulating agent (ESA) approved for both once weekly (QW) and once every three weeks (Q3W) dosing 1, 2 Aranesp dosing options of QW or Q3W may allow for synchronization with common myelosuppressive chemotherapy regimens. Epub 2016 Mar 4. Disclaimer. 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. Protect vials and prefilled syringes from light. The site is secure. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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 .
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