aranesp to retacrit conversion

Reduce or withhold RETACRIT if blood pressure becomes difficult to control. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Questions regarding Results: Supplied Injection, powder for reconstitution: 5 mg, INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. HrsW-D/tCPs. 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. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. <>/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 Based on the patient's response, darbepoetin Background Anaemia is defined as a reduction of haemoglobin concentration, red . Aranesp | European Medicines Agency ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance erythropoietin, darbepoetin alfa stimulates erythropoiesis. Epogen is used in the dialysis area at CCF. Darbepoetin alfa, although several fold more biologically Avoid frequent dose adjustments. Evaluate other causes of anemia. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). In the near future, the Pharmacy and Therapeutics It is used in two groups of patients: adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly); adults who are receiving chemotherapy for nonmyeloid cancer (cancer not originating in . There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. 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. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. 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. The .gov means its official. 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. More specifically, 23 patients in the epoetin alfa group Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee 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. 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. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicatedfor: Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis of Pharmacy Drug Information Center (216-444-6456, option #1). 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. 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. Mean baseline Hgb levels The majority of patients with CKD will require supplemental iron during the course of ESA therapy. W bO? 1022 0 obj (CKD) patients, darbepoetin alfa administered intravenously has of patients receiving transfusions was similar between the groups, Ann Pharmacother. Amgen scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ RETACRIT is a registered trademark of Pfizer Inc. Epogen is a registered trademark of Amgen Inc. Procrit is a registered trademark of Janssen Products, LP. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Approved by FMOLHS P&T. . FDA approves first epoetin alfa biosimilar for the treatment of anemia The number Evaluate the iron status in all patients before and during treatment. <> Pfizer for Professionals 1-800-505-4426 4. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r SN:]AW&g{auwi(D)Si'(EK 9P$a8d_R/au&tIk=[A'"Uh 5E~"{dC4dMs/*e?&Io}a\d05zVJ)~OL:MK'tiM>)r4zoBp`Vju`'78f4*q-PFa_,R2(r\?ASM^B6DT&s+IfUSqS6H5l~b)lMx:'j_sT[.q"ju g/8f5>tWw]}vAQNK0: st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c Darbepoetin alfa (Aranesp) Place of Service Hospital Administration 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g.febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Epoetin alfa. endobj What is the practical conversion dose when changing from epoetin alfa The .gov means its official.Federal government websites often end in .gov or .mil. 4 x previous weekly epoetin alfa dose (Units)/125. stream and approved an automatic therapeutic interchange to darbepoetin Available for Android and iOS devices. Last updated on Jan 20, 2023. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody dependent killing, and the increased expression of some functions associated with cell surface antigens). Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 microg/week (P = 0.02). Methods: Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: 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%. 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. In addition, Hgb levels were A target Patient treatments were converted from subcutaneous epoetin alfa to weekly, intravenous darbepoetin alfa at month 0, at a conversion dose of 200 units epoetin alfa to 1 microg darbepoetin. JKn&,&LzN 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx 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. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Product Information and Dosing | Mircera The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. 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 . . In chronic kidney disease Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks and iron stores are adequate: Increase by ~25% of the previous dose; increases should not be made more frequently than once monthly. Clipboard, Search History, and several other advanced features are temporarily unavailable. 335 0 obj <>stream 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) Unable to load your collection due to an error, Unable to load your delegates due to an error. Do not re-enter vial. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. 8600 Rockville Pike VII, No. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Pussell BA, Walker R; Australian Renal Anaemia Group. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Mircera Dosage Guide - Drugs.com AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. Internal Data: A retrospective drug use evaluation (DUE) was conducted To report an adverse event, please call 1-800-438-1985. a half-life of 25.3 hours compared to epoetin alfa, which has a government site. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week Colony Stimulating Factors - GlobalRPH If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. %%EOF There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. Nephrology (Carlton). Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 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. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. This site needs JavaScript to work properly. 1057 0 obj 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). Do not mix with other drug solutions. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. as well). most common dosing regimens are 40,000 units weekly for epoetin CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. Retacrit has been approved as a biosimilar, not as an interchangeable product. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. 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. In patients receiving treatment for cancer and whose anemia is not due to CKD. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. 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. patients had to be initiated on epoetin alfa or darbepoetin alfa 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. 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. 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. The information provided is for educational purposes only. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. When therapy with RETACRITis needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy, In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure, In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion, In patients scheduled for surgery who are willing to donate autologous blood, In patients undergoing cardiac or vascular surgery, As a substitute for RBC transfusions in patients who require immediate correction of anemia, Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs, Serious allergic reactions to RETACRIT or other epoetin alfa products, Neonates, infants, pregnant women, and lactating women. Conversion from Another ESA: dosed once every 4 weeks based on total Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. 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. Dr. Gerald Diaz @GeraldMD. %PDF-1.5 Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly.In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. The most frequent dosing regimens were 40,000 units weekly Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Dose adjustment: If response is not satisfactory after a sufficient period of evaluation (8 weeks of 3 times/week and 4 weeks of once weekly therapy), the dose may be increased every 4 weeks (or longer) up to 300 units/kg 3 times/week, or when dosed weekly, increased all at once to 60,000 units weekly. 7/2021: added Epogen (nonformulary). PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb 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. 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. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). These are recommended Darbepoetin alfa. The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. <> : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Use caution in patients with coexistent cardiovascular disease and stroke. 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. We comply with the HONcode standard for trustworthy health information. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. PDF Home Dialysis Programs Standing Orders - Erythropoietin Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . for epoetin alfa-treated patients and 200 mcg every 2 weeks (or The average 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. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. in patients with chronic anemia of cancer as well as CIA document Please enable it to take advantage of the complete set of features! This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Pharmacotherapy Update - Automatic Therapeutic Interchange Program 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. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. maintain desired hemoglobin (Hgb) levels. 1121 0 obj ChronicKidney Disease: 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. National Library of Medicine Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs).

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