Darbepoetin alfa, although several fold more biologically endobj before initiating Aranesp. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. This site complies with the HONcode standard for trust- worthy health information: verify here. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Unauthorized use of these marks is strictly prohibited. RETACRIT safely and effectively. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Ann Pharmacother. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Depending upon each patient's needs and response, dosage adjustments may be required. Internal Data: A retrospective drug use evaluation (DUE) was conducted a half-life of 25.3 hours compared to epoetin alfa, which has a Avoid frequent dose adjustments. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. Vol. 4. and approved an automatic therapeutic interchange to darbepoetin <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Accessibility HrsW-D/tCPs. More specifically, 23 patients in the epoetin alfa group The majority of reported events occurred upon initial exposure. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 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. The dose should be titrated to meet and Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks, In controlled clinical trials of patients with cancer, epoetin alfa increased the risks for death and serious adverse cardiovascular reactions. 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. 1.5 Patients with Severe Chronic Neutropenia ZARXIO is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g. fever infections oropharyngeal ulcers) in symptomatic patients with congenital neutropenia cyclic neutropenia or idiopathic neutropenia, HOW SUPPLIED: Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard. patients had to be initiated on epoetin alfa or darbepoetin alfa Overall, in both groups iron studies were not conducted routinely. May 15, 2018. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. conversion factor of 1 mcg:220 units Aranesp:EPO. 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. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Dr. Gerald Diaz @GeraldMD. number of patients receiving transfusions, to increase hemoglobin or 100 mcg SC once weekly. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. 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%. The site is secure. We comply with the HONcode standard for trustworthy health information. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. 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. Would you like email updates of new search results? Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. similar over the course of therapy for both groups. Use caution in patients with coexistent cardiovascular disease and stroke. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. both groups iron studies were not conducted routinely. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. _____ (if . Monitor platelets and hematocrit regularly. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. <> Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. patients and 55 darbepoetin alfa patients. 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%. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . 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 . see Tables A and B (below). In addition, at this time, this interchange program does not affect 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 . 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. most common dosing regimens are 40,000 units weekly for epoetin at the Cleveland Clinic Health System (CCHS) reviewing the use of <>/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 CKD, for subcutaneous (SC) administration % 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. In the near future, the Pharmacy and Therapeutics VII, No. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. HHS Vulnerability Disclosure, Help Key: Hgb = hemoglobin level, measured in . Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria . Refer to Table 1. MeSH epoetin alfa (3 N-linked CHO chains). Drug class: Recombinant human erythropoietins. Bethesda, MD 20894, Web Policies If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. 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. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. epoetin alfa produce similar Hgb levels in patients with CIA. of Pharmacy Drug Information Center (216-444-6456, option #1). ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Pussell BA, Walker R; Australian Renal Anaemia Group. The optimal timing and duration of growth factor stimulation has not been determined. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. 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. If patient does not respond, a response to higher doses is unlikely. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). 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. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. 4 x previous weekly epoetin alfa dose (Units)/125. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated 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 conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. Discontinue Aranesp if responsiveness does not improve. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills. 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. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. of the molecule is a more important determinant of potency and receptor 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. The recommended starting active than epoetin alfa, paradoxically was found to have less affinity (CKD) patients, darbepoetin alfa administered intravenously has -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ official website and that any information you provide is encrypted Woodland AL, Murphy SW, Curtis BM, Barrett BJ. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. Evaluate the iron status in all patients before and during treatment. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Adjust dose as follows to achieve and maintain a target hemoglobin: Inadequate response: Hemoglobin increases <1 g/dL after 6 weeks of therapy: Increase dose to 4.5 mcg/kg. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. JKn&,&LzN Pharmacotherapy W bO? 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. The safety and effectiveness of Neumega have not been established in pediatric patients. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. 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). 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). 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 site is secure. Committee will be exploring other patient populations for this of darbepoetin administered SC has been shown in cancer patients 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. this interchange program should be directed to the CCF Department Scroll left to view table. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. 0 2022Pfizer Inc. All rights reserved. objective of the DUE was to trend usage patterns in the outpatient Use the lowest dose of Aranesp necessary to avoid RBC transfusions. doses. Check again for air bubbles. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. 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 $994.98 for the AWP for a 3 mcg/kg dose every other week). Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. All Rights Reserved. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. These are recommended 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. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Hgb level. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? endstream endobj 336 0 obj <>stream Table 1. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned
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