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hemoglobin of > 12 g/dL was reached in 47 patients (41%) Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. . The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. 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. REASON FOR . 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. These are recommended Nephrol Dial Transplant. In cancer patients, erythropoietic agents, including 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. %PDF-1.6 % patients and 55 darbepoetin alfa patients. 335 0 obj <>stream 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). In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. 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. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u 4. scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ number of patients receiving transfusions, to increase hemoglobin The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa 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. Use caution in patients with coexistent cardiovascular disease and stroke. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC 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 RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) These are recommended doses. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. patients had to be initiated on epoetin alfa or darbepoetin alfa Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. 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. 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. <>/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 : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh 1057 0 obj as well). 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Nephrology (Carlton). RETACRIT is contraindicated in patients with: RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM, INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER, LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT, RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE, ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE, ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER, ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION, Recommended dosing for adults and children with chronic kidney disease (CKD), The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously (IV) or subcutaneously (SC). 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. Methods: Questions regarding 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. 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. Contributed by. 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. 1022 0 obj 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. Neulasta should be permanently discontinued in patients with serious allergic reactions. 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. 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. Serious allergic reactions to OMONTYS. RETACRIT safely and effectively. Last updated on Jan 20, 2023. 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). b. 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. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. epoetin alfa produce similar Hgb levels in patients with CIA. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Slowly push the plunger up to force the air bubbles out of the syringe. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? We comply with the HONcode standard for trustworthy health information. 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 . Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). 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. 1. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. <> In the near future, the Pharmacy and Therapeutics Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Maintain the route of administration (intravenous or subcutaneous injection). Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life arena for dosing, dosing interval, hemoglobin levels, number of As a substitute for RBC transfusions in patients who require immediate correction of anemia. 2 0 obj Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 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. Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed this interchange program should be directed to the CCF Department Accessibility Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Reduce or withhold RETACRIT if blood pressure becomes difficult to control. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or 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. . Conversion of IV to SC EPO: a. 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. 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. endobj Background: Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. (CKD) patients, darbepoetin alfa administered intravenously has PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna government site. Do Not Copy, Distribute or otherwise Disseminate without express permission. FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA chemotherapy. epoetin alfa and darbepoetin alfa, have been shown to decrease the Hgb level. The recommended starting _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx Medically reviewed by Drugs.com. The recommended starting dose for pediatric patients (less than 18 years) is 0.45 mcg/kg body weight administered as a single subcutaneous or intravenous injection once weekly; patients not receiving dialysis may be initiated at a dose of 0.75 mcg/kg once every 2 weeks. 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. PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb This site is intended only for U.S. healthcare professionals. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and U.S.-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products. 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 . Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. Before 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. Epub 2016 Mar 4. Response rates are defined 7/2021: added Epogen (nonformulary). PDF Home Dialysis Programs Standing Orders - Erythropoietin PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu The https:// ensures that you are connecting to the The site is secure. 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). VII, No. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU). objective of the DUE was to trend usage patterns in the outpatient RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. % 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. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Committee will be exploring other patient populations for this OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Refer to Aranesp package insert for pediatric dosing conversion. 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. Vol. 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 . Retacrit has been approved as a biosimilar, not as an interchangeable product. Mean baseline Hgb levels It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. group. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. contracts, darbepoetin alfa is less expensive than epoetin alfa. Product Information and Dosing | Mircera Evaluate the iron status in all patients before and during treatment. (PDF) Conversion from epoetin beta to darbepoetin: What is the The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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). 2. therapy. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. Darbepoetin alfa (5 N-linked In chronic kidney disease The dose should be titrated to meet and National Library of Medicine Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. W bO? David McAuley, Pharm.D. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Epogen is used in the dialysis area at CCF. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 33 Dose. Based on market share sharing sensitive information, make sure youre on a federal Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. for at least 3 weeks between July 2002 and July 2003. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Key: Hgb = hemoglobin level, measured in . Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. However, this may result in the over treatment of uraemic anaemia. alfa-treated patients, respectively. Do not use Aranesp that has been shaken or frozen. An official website of the United States government. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). eCollection 2017. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. . See full prescribing information for RETACRIT. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . 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. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. INDICATIONS AND USAGE Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician.