alfa is as well tolerated and efficacious as epoetin alfa even when Table 1. 4 0 obj Can J Kidney Health Dis. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). at the Cleveland Clinic Health System (CCHS) reviewing the use of Bookshelf At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Call 1-888-4ASSIST to find out more. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. 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. In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. maintain desired hemoglobin (Hgb) levels. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. 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. 2 0 obj Do not mix with other drug solutions. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Pharmacotherapy 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. transfusions, and iron studies. Darbepoetin alfa, although several fold more biologically Please enable it to take advantage of the complete set of features! k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Colony Stimulating Factors - GlobalRPH Accessibility Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) Ann Pharmacother. All Rights Reserved. Study of Transplant Related Anemia Treated With Aranesp (STRATA The implementation date for the interchange program is October 11, 2004. endstream endobj 336 0 obj <>stream REASON FOR . The endobj Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. ChronicKidney Disease: 4 x previous weekly epoetin alfa dose (Units)/125. Similar to endogenous of the molecule is a more important determinant of potency and receptor Do Not Copy, Distribute or otherwise Disseminate without express permission. or 100 mcg SC once weekly. <> endstream 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. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. This site complies with the HONcode standard for trust- worthy health information: verify here. b. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. The majority of reported events occurred upon initial exposure. 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. 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. for at least 3 weeks between July 2002 and July 2003. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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 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. administered less frequently. Would you like email updates of new search results? CHO chains) has a 3-fold increase in half-life when compared to _____ (if . Serious allergic reactions to OMONTYS. chemotherapy. 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%. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Disclaimer. stream in two ways: 1) Hgb levels > 12 g/dL or 2) an increase epoetin alfa produce similar Hgb levels in patients with CIA. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Pfizer for Professionals 1-800-505-4426 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. 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 . 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. VII, No. eCollection 2017. Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human . 2022Pfizer Inc. All rights reserved. alfa-treated patients, respectively. Safety and Efficacy: Currently available data indicate that darbepoetin Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. FOIA Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. of Pharmacy Drug Information Center (216-444-6456, option #1). Woodland AL, Murphy SW, Curtis BM, Barrett BJ. IV Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Darbepoetin alfa. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . Reduce or withhold RETACRIT if blood pressure becomes difficult to control. An official website of the United States government. AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. 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. 1022 0 obj Please review the latest applicable package insert for additional information and possible updates. Discard unused portion of Aranesp in vials or prefilled syringes. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Do not increase the dose more frequently than once every 4 weeks. as well). Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu see Tables A and B (below). When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. <>/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 CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Aranesp (darbepoetin alfa) | Dosing Considerations 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). 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. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. doses. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.