aranesp to retacrit conversion

interchange, such as patients with chronic renal failure (CRF). If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. alfa-treated patients, respectively. Existing patients on IV EPO, change to subcutaneous EPO using the . <>/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 Epogen (Amgen), another brand name for epoetin most common dosing regimens are 40,000 units weekly for epoetin Severe chronic neutropenia: Congenital: 6 mcg/kg twice daily Idiopathic/cyclic: 5 mcg/kg/day, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9222, Supplied: Injection, solution [preservative free]: 300 mcg/mL (1 mL, 1.6 mL) [vial; contains sodium 0.035 mg/mL and sorbitol], Injection, solution [preservative free]: 600 mcg/mL (0.5 mL, 0.8 mL) [prefilled Singleject syringe; contains sodium 0.035 mg/mL and sorbitol], Drug UPDATES: ZARXIO - filgrastim-sndz injection [Drug information / PDF] Click link for the latest monographDosing: Click (+) next to Dosage and Administration section (drug info link). In cancer patients, erythropoietic agents, including Hgb level. %%EOF <>>> The information provided is for educational purposes only. 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. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . The 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. Epub 2009 Aug 4. 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. More specifically, 23 patients in the epoetin alfa group *Z?PkIV/X8$yN7.7 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). See full prescribing information for RETACRIT. doses. REASON FOR . Do Not Copy, Distribute or otherwise Disseminate without express permission. Epub 2005 Dec 6. epoetin alfa and darbepoetin alfa for the management of CIA. The safety and effectiveness of Neumega have not been established in pediatric patients. All Rights Reserved. every-other-week) for darbepoetin alfa-treated patients. Key: Hgb = hemoglobin level, measured in . This site is intended only for U.S. healthcare professionals. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 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`~ 2 0 obj The implementation date for the interchange program is October 11, 2004. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). 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. 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%. patients and 55 darbepoetin alfa patients. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. erythropoietin, darbepoetin alfa stimulates erythropoiesis. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Learn how to combine multiple dosing options for precise titration and individualize anemia management. affinity has no or little clinical relevance. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? contracts, darbepoetin alfa is less expensive than epoetin alfa. endstream endobj 336 0 obj <>stream IV Discard unused portion of Aranesp in vials or prefilled syringes. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 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. 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. 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. 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. Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1). %PDF-1.6 % The https:// ensures that you are connecting to the The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Before sharing sensitive information, make sure you're on a federal government site. 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)]. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. epoetin alfa produce similar Hgb levels in patients with CIA. Pfizer for Professionals 1-800-505-4426 Use caution in patients with coexistent cardiovascular disease and stroke. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. therapy. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; of patients receiving transfusions was similar between the groups, Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. endobj and 24 patients in the darbepoetin alfa group reached the targeted Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. 2. Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Careers. patients had to be initiated on epoetin alfa or darbepoetin alfa As a substitute for RBC transfusions in patients who require immediate correction of anemia. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. response rates ranging from ~60% to 85%. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions, Epoetin alfa products, including RETACRIT, increase the risk of seizures in patients with CKD. Serious allergic reactions to OMONTYS. as well). 4 x previous weekly epoetin alfa dose (Units)/125. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. 150 units/kg SC 3 times/week or 40,000 units once weekly. Nephrology (Carlton). Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, and 40,000 Units of epoetin alfa-epbx injection contains 0.5 mg of phenylalanine. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. before initiating Aranesp. Please review the latest applicable package insert for additional information and possible updates. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human . for at least 3 weeks between July 2002 and July 2003. Epub 2016 Mar 4. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh Response rates are defined Please enable it to take advantage of the complete set of features! epoetin alfa (3 N-linked CHO chains). 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: When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. This site complies with the HONcode standard for trust- worthy health information: verify here. Methods: While a discounted alternative to Epogen and Procrit is welcome, there is a catch. FOIA 335 0 obj <>stream in patients with chronic anemia of cancer as well as CIA document Do not dilute. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Epoetin alfa. Questions regarding Slowly push the plunger up to force the air bubbles out of the syringe. 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. Bethesda, MD 20894, Web Policies The site is secure. Aranesp is administered less frequently than epoetin alfa. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Based on market share Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u 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. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Epogen is used in the dialysis area at CCF. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. The recommended starting Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Refer to Table 1. AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. Protect vials and prefilled syringes from light. 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). No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. 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 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. 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).

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