Do not use Aranesp that has been shaken or frozen. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. . 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. 335 0 obj <>stream Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. 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. 33 Dose. Please review the latest applicable package insert for additional information and possible updates. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit 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. VII, No. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 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. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. <> Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. (CIA) for both outpatients and inpatients. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. 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. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. . Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Wien Med Wochenschr. Dr. Gerald Diaz @GeraldMD. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. and approved an automatic therapeutic interchange to darbepoetin Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Epogen (Amgen), another brand name for epoetin %%EOF 1. The number transfusions, and iron studies. Decreases in dose can occur more frequently. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. arena for dosing, dosing interval, hemoglobin levels, number of Follow the Oncology Center of Excellence on Twitter @FDAOncology. 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). 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. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. 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. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN $l-FRW+>U0pPhRc/N R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" Hgb level. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. 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 . 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. In CKD, for subcutaneous (SC) administration levels, and to improve quality of life. 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. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. The most frequent dosing regimens were 40,000 units weekly The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. More specifically, 23 patients in the epoetin alfa group chemotherapy. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 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). affinity has no or little clinical relevance. %PDF-1.6 % Would you like email updates of new search results? PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Evaluate other causes of anemia. 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 . DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. before initiating Aranesp. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh DOSAGE FORMS AND STRENGTHS Dosage Form Strengths Single use vials (preservative-free) 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Single use pre-filled syringes (preservative-free) 1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Multiple use vials (with preservative) 10 mg/mL and 20 mg/2 mL, CONTRAINDICATIONS: Uncontrolled hypertension. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. 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). Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. in Hgb of 2 g/dL from baseline. Do not re-enter vial. Mechanism of Action: Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation differentiation commitment and some end-cell functional activation. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin Before sharing sensitive information, make sure you're on a federal government site. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. The site is secure. 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. <>stream Overall, in Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. 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. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Epub 2014 Aug 14. Evaluate the iron status in all patients before and during treatment. 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. Discard unused portion of Aranesp in vials or prefilled syringes. 8600 Rockville Pike <>>> Conclusion: National Library of Medicine Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. However, this may result in the over treatment of uraemic anaemia. W bO? Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. This site is intended for U.S. healthcare professionals. 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%. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. 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. The optimal timing and duration of growth factor stimulation has not been determined. AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. 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 . objective of the DUE was to trend usage patterns in the outpatient 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; 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: The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. JKn&,&LzN 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. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. REASON FOR . Production 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. A single hemoglobin excursion may not require a dosing change. A total of Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Note: The manufacturer states that, until efficacy/toxicity parameters are established, the use of oprelvekin in pediatric patients (particularly those <12 years of age) should be restricted to use in controlled clinical trials. Retacrit has been approved as a biosimilar, not as an interchangeable product. b. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. 3 0 obj 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. sharing sensitive information, make sure youre on a federal contracts, darbepoetin alfa is less expensive than epoetin alfa. endobj 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`~ 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. 1 0 obj Initial U.S. Approval: 2018 . RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . Avoid frequent dose adjustments. In order to be included in the DUE, PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). adjustments may be required. Before 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. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. 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. The 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. this interchange program should be directed to the CCF Department Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. erythropoietin, darbepoetin alfa stimulates erythropoiesis. 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). Please enable it to take advantage of the complete set of features! 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Copyright 1993-2021 Key: Hgb = hemoglobin level, measured in . 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. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Neulasta should be permanently discontinued in patients with serious allergic reactions. 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. Committee will be exploring other patient populations for this in two ways: 1) Hgb levels > 12 g/dL or 2) an increase OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). 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.
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