<> PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Overall, only 10.5% of patients had iron studies before erythropoietin Approved by FMOLHS P&T. . 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. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. 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. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. Careers. Disclaimer. RETACRIT Instructions For Use (epoetin alfa-epbx) eCollection 2017. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. To report an adverse event, please call 1-800-438-1985. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. Evaluation of Iron Stores and Nutritional Factors. 4 0 obj Protect vials and prefilled syringes from light. 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy ZARXIO is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)]. <>stream !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X T]{oF`S}+c|yt} } ;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL` z0 DY%--V! (CKD) patients, darbepoetin alfa administered intravenously has arena for dosing, dosing interval, hemoglobin levels, number of Epub 2009 Aug 4. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. contracts, darbepoetin alfa is less expensive than epoetin alfa. 4. %PDF-1.6 % In the near future, the Pharmacy and Therapeutics Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. 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. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. Background: Before sharing sensitive information, make sure you're on a federal government site. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. IV epoetin alfa and darbepoetin alfa, have been shown to decrease the 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. 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)]. Before Recommended regimens for patients undergoing elective, noncardiac, nonvascular surgery, 300 Units/kg per day SC for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery, 600 Units/kg SC in 4 doses, administered 21, 14, and 7 days before surgery and on the day of surgery. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ Nephrol Dial Transplant. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL The majority of reported events occurred upon initial exposure. 3 0 obj Call 1-888-4ASSIST to find out more. All Rights Reserved. % doses. 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. Epub 2005 Dec 6. number of patients receiving transfusions, to increase hemoglobin Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u overall. PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration Evaluate the iron status in all patients before and during treatment. 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. Colony Stimulating Factors - GlobalRPH 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. 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. Mircera Dosage Guide - Drugs.com Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Contributed by. in Hgb of 2 g/dL from baseline. 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. See full prescribing information for RETACRIT. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. 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. Epub 2014 Jan 31. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee 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 . 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. Training should aim to demonstrate to those patients and caregivers how to measure the dose of Aranesp, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for a prefilled syringe. In order to be included in the DUE, Based on the patient's response, darbepoetin Federal government websites often end in .gov or .mil. endobj OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. affinity has no or little clinical relevance. CHO chains) has a 3-fold increase in half-life when compared to GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. 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. 7/2021: added Epogen (nonformulary). The information provided is for educational purposes only. >/@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 The average half-life of 8.5 hours. 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. endobj Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated 1022 0 obj If there are still air bubbles, repeat the steps above to remove them. epoetin alfa and darbepoetin alfa for the management of CIA. 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 Mean baseline Hgb levels Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The .gov means its official.Federal government websites often end in .gov or .mil. AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. or 100 mcg SC once weekly. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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. Conversion from Another ESA: dosed once every 4 weeks based on total 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). Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). alfa is as well tolerated and efficacious as epoetin alfa even when : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. 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. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Last updated on Jan 20, 2023. For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). What is the difference between Retacrit and Procrit? - Drugs.com David McAuley, Pharm.D. 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).
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