RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . Do not increase the dose more frequently than once every 4 weeks. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. Safety and Efficacy: Currently available data indicate that darbepoetin
Existing patients on IV EPO, change to subcutaneous EPO using the . Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. 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. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin
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. 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. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . 2022Pfizer Inc. All rights reserved. Bookshelf Methods: Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy.
Maintain the route of administration (intravenous or subcutaneous injection). Do not dilute. Studies of erythropoietin therapy
If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub <>
Woodland AL, Murphy SW, Curtis BM, Barrett BJ. 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. July/August 2004, Return to
In addition, Hgb levels were
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st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c of Pharmacy Drug Information Center (216-444-6456, option #1). The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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. similar over the course of therapy for both groups. Approved by FMOLHS P&T. . Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. <> Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. 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. 1. Epub 2004 Feb 19. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . 335 0 obj
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2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. This site complies with the HONcode standard for trust- worthy health information: verify here. Initial U.S. Approval: 2018 . Epogen (Amgen), another brand name for epoetin
Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee
G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation, and selected end-cell functions (including enhanced phagocytic ability priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and the increased expression of some cell surface antigens). eCollection 2017.
Aranesp Dosage Guide - Drugs.com Discontinue RETACRIT therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected, RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women. Before In patients receiving treatment for cancer and whose anemia is not due to CKD. Update Index. A local search option of this data can be found here. endobj
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. Clipboard, Search History, and several other advanced features are temporarily unavailable. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u
Switching Between Epoetins: A Practice in Support of Biosimilar Use 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. The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. Epub 2014 Aug 14. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter.
PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Mean baseline Hgb levels
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May 15, 2018. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin.
Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed Please enable it to take advantage of the complete set of features! interchange, such as patients with chronic renal failure (CRF). CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product.
PDF Home Dialysis Programs Standing Orders - Erythropoietin HHS Vulnerability Disclosure, Help
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. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. overall. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. 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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. 4y\@:hT4\j
EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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.
RETACRIT Dosage and Administration (epoetin alfa-epbx) 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x.
RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 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. see Tables A and B (below). 0 . %PDF-1.6
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1057 0 obj General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. 4 0 obj
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 . 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. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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%. In the near future, the Pharmacy and Therapeutics
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. IV
Can J Kidney Health Dis. The
in Hgb of 2 g/dL from baseline. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or
FDA approves first epoetin alfa biosimilar for the treatment of anemia Conversion of IV to SC EPO: a.
Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp.
PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu 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. 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.
PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa endobj
Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Questions regarding
W bO? PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). 4. 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. The majority of reported events occurred upon initial exposure. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. (CIA) for both outpatients and inpatients.
PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Learn how to combine multiple dosing options for precise titration and individualize anemia management. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Nephrol Dial Transplant. In pediatric patients, Mircera is administered by intravenous injection only (2.2). RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . 150 units/kg SC 3 times/week or 40,000 units once weekly. Use caution in patients with coexistent cardiovascular disease and stroke. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . alfa and 200 mcg every 2 weeks for darbepoetin alfa. 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. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Aranesp Dosing and Conversion Brochure.
PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). Darbepoetin alfa (5 N-linked
2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Follow the Oncology Center of Excellence on Twitter @FDAOncology. scMJkP`@SzQ`
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RETACRIT single-dose vials contain phenylalanine, a component of aspartame. 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 $994.98 for the AWP for a 3 mcg/kg dose every other week). In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. Depending upon each patient's needs and response, dosage
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PDF Highlights of Prescribing Information ----------------------- Dosage administered less frequently. About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG
M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Epogen is used in the dialysis area at CCF. 8600 Rockville Pike Careers. group. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 These are recommended
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. 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). a half-life of 25.3 hours compared to epoetin alfa, which has a
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Refer to Table 1. %PDF-1.6
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If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Before sharing sensitive information, make sure you're on a federal government site. Slowly push the plunger up to force the air bubbles out of the syringe. _____ (if . 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`~ objective of the DUE was to trend usage patterns in the outpatient
endobj 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. This site is intended only for U.S. healthcare professionals. National Library of Medicine k22atr
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What is the practical conversion dose when changing from epoetin alfa Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. This site is intended for U.S. healthcare professionals. <>/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
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Refer to Aranesp package insert for pediatric dosing conversion. Pussell BA, Walker R; Australian Renal Anaemia Group. Epub 2009 Aug 4. 1 0 obj
therapy. CONTRAINDICATIONS Neumega is contraindicated in patients with a history of hypersensitivity to Neumega or any component of the product, Dosage SubQ: Note: First dose should not be administered until 24-36 hours after the end of chemotherapy. 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. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. 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. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. 3 0 obj
at the Cleveland Clinic Health System (CCHS) reviewing the use of
: RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh Generic name: DARBEPOETIN ALFA 10ug in 0.4mL