overall. affinity has no or little clinical relevance. Evaluate the iron status in all patients before and during treatment. 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 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; RETACRIT safely and effectively. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. 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. 33 Dose. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. A total of The optimal timing and duration of growth factor stimulation has not been determined. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. Beneficial dose conversion after switching from higher doses of shorter-acting erythropoiesis-stimulating agents to C.E.R.A in CKD patients in clinical practice: MINERVA Study. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Overall, in both groups iron studies were not conducted routinely. JKn&,&LzN 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). The .gov means its official.Federal government websites often end in .gov or .mil. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Epub 2014 Aug 14. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. 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. 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. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. 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). Please enable it to take advantage of the complete set of features! Epub 2016 Mar 4. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Depending upon each patient's needs and response, dosage The information provided is for educational purposes only. A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. Initiate Aranesp in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy. Pull the plunger back to the number on the syringe that matches your dose. The probability of switching between different epoetins was associated with the duration of treatment: about 15 % of users switched within 12 months and almost 25 % within 2 years of observation. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefits. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Both Retacrit and Procrit are approved for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. Pfizer for Professionals 1-800-505-4426 Federal government websites often end in .gov or .mil. The site is secure. response rates ranging from ~60% to 85%. Conversion of IV to SC EPO: a. An official website of the United States government, : 7/2021: added Epogen (nonformulary). number of patients receiving transfusions, to increase hemoglobin 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. and transmitted securely. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. endobj -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. >/@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 Dosage form: injection, solution 1 0 obj 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). Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Last updated on Jan 20, 2023. Learn how to combine multiple dosing options for precise titration and individualize anemia management. Committee will be exploring other patient populations for this In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. 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. RETACRIT is a registered trademark of Pfizer Inc. Epogen is a registered trademark of Amgen Inc. Procrit is a registered trademark of Janssen Products, LP. 4. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Can J Kidney Health Dis. Protect vials and prefilled syringes from light. Clipboard, Search History, and several other advanced features are temporarily unavailable. This site needs JavaScript to work properly. 0 in Hgb of 2 g/dL from baseline. startxref The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. endstream endobj 336 0 obj <>stream The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. W bO? group. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Serious allergic reactions to OMONTYS. The safety and effectiveness of Neumega have not been established in pediatric patients. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. In order to be included in the DUE, stream Recommended regimens for patients undergoing elective, noncardiac, nonvascular surgery, 300 Units/kg per day SC for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery, 600 Units/kg SC in 4 doses, administered 21, 14, and 7 days before surgery and on the day of surgery. Key: Hgb = hemoglobin level, measured in . Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). The intravenous route is recommended for patients on hemodialysis. transfusions, and iron studies. Do not increase the dose more frequently than once every 4 weeks. %PDF-1.5 patients and 55 darbepoetin alfa patients. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). The products discussed in this site may have different product labeling in different countries. of Pharmacy Drug Information Center (216-444-6456, option #1). Refer to Table 1. <>>> Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. every-other-week) for darbepoetin alfa-treated patients. Overall, only 10.5% of patients had iron studies before erythropoietin k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC both groups iron studies were not conducted routinely. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: adverse event to Retacrit (epoetin alfa), and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information; OR For patients that are currently on treatment with Aranesp (darbepoetin alfa) they can remain on Epub 2009 Aug 4. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . VII, No. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. . endobj The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. The average 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. Darbepoetin alfa (5 N-linked 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. Epoetin alfa. 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. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 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. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh While a discounted alternative to Epogen and Procrit is welcome, there is a catch. 150 units/kg SC 3 times/week or 40,000 units once weekly. 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. The number Existing patients on IV EPO, change to subcutaneous EPO using the . Darbepoetin alfa, although several fold more biologically 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. 1. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. In cancer patients, erythropoietic agents, including National Library of Medicine FOIA The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Coverage Limitations Treatment with Darbepoetin alfa (Aranesp), Epoetin alfa (Procrit), Epoetin alfa (Epogen), and Epoetin alfa-epbx (Retacrit) is not considered medically necessary for members with the following concomitant conditions: hemoglobin of > 12 g/dL was reached in 47 patients (41%) similar over the course of therapy for both groups. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . The Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. An official website of the United States government. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. 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. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Round the dose to the nearest treatment tier. Medically reviewed by Drugs.com. Epub 2014 Jan 31. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. To report an adverse event, please call 1-800-438-1985. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Would you like email updates of new search results? Safety and Efficacy: Currently available data indicate that darbepoetin This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. CHO chains) has a 3-fold increase in half-life when compared to These are recommended active than epoetin alfa, paradoxically was found to have less affinity 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 . DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. Do Not Copy, Distribute or otherwise Disseminate without express permission. of endogenous erythropoietin may be impaired in patients receiving Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Epogen is used in the dialysis area at CCF. of the molecule is a more important determinant of potency and receptor endstream <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Conclusion: All Rights Reserved. alfa for chronic anemia of cancer and chemotherapy-induced anemia Overall, in Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Maintain the route of administration (intravenous or subcutaneous injection). 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. Depending upon each patient's needs and response, dosage adjustments may be required. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. 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 . Based on the patient's response, darbepoetin Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa 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 . endobj 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. The implementation date for the interchange program is October 11, 2004. A single hemoglobin excursion may not require a dosing change. Copyright 1993-2021 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. 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)]. 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. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Use caution in patients with coexistent cardiovascular disease and stroke. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Disclaimer. maintain desired hemoglobin (Hgb) levels. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. 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). Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. 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. 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. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Neulasta should be permanently discontinued in patients with serious allergic reactions. in patients with chronic anemia of cancer as well as CIA document Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Aranesp Dosing and Conversion Brochure. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit 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. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. PMC Do not dilute. 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. 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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. endobj official website and that any information you provide is encrypted Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. 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. The recommended starting The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? 3 0 obj The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. The site is secure. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. These are recommended doses. 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)]. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. 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. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). 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. see Tables A and B (below). At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . epoetin alfa and darbepoetin alfa, have been shown to decrease the duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin 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. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. endobj Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). for at least 3 weeks between July 2002 and July 2003. (CIA) for both outpatients and inpatients. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. epoetin alfa (3 N-linked CHO chains). 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. Keep the tip of the needle in the RETACRIT liquid. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin doses. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or <> _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K)