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. 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. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. 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. Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. endobj Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. 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. 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: Contributed by. alfa may be administered as frequently as once every 3 or 4 weeks. and 24 patients in the darbepoetin alfa group reached the targeted Epub 2014 Jan 31. Dr. Gerald Diaz @GeraldMD. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. %PDF-1.6 % PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). Background: The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 33 Dose. PMC Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Do not increase the dose more frequently than once every 4 weeks. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. (CIA) for both outpatients and inpatients. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 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. Use caution in patients with coexistent cardiovascular disease and stroke. 335 0 obj <>stream in Hgb of 2 g/dL from baseline. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. endobj 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. group. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. Do not mix with other drug solutions. 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. In order to be included in the DUE, 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. Evaluation of Iron Stores and Nutritional Factors. 1 0 obj Vol. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. endobj Can J Kidney Health Dis. In the near future, the Pharmacy and Therapeutics Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. erythropoietin, darbepoetin alfa stimulates erythropoiesis. The IV route is recommended for patients on hemodialysis, For adult patients with CKD not on dialysis, The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC, The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly IV or SC, Recommended dosing for patients with HIV treated with zidovudine, The recommended starting dose in adults is 100 Units/kg as an IV or SC injection 3 times per week, If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid red blood cell (RBC) transfusions or 300 Units/kg, Recommended starting dose for adults and children undergoing cancer chemotherapy*, 150 Units/kg SC 3 times per week until completion of a chemotherapy course, or, 40,000 Units SC weekly until completion of a chemotherapy course, 600 Units/kg IV weekly until completion of a chemotherapy course. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. endobj Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. Epub 2005 Dec 6. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: 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 benefits. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin 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. 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 . and approved an automatic therapeutic interchange to darbepoetin levels, and to improve quality of life. 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. Federal government websites often end in .gov or .mil. 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)]. Keep the tip of the needle in the RETACRIT liquid. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 4 x previous weekly epoetin alfa dose (Units)/125. most common dosing regimens are 40,000 units weekly for epoetin In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. alfa for chronic anemia of cancer and chemotherapy-induced anemia 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. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. 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. . 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. Medically reviewed by Drugs.com. The dose should be titrated to meet and !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! Darbepoetin alfa, although several fold more biologically ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. 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. Avoid frequent dose adjustments. MeSH duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin doses. 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. 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). This site needs JavaScript to work properly. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. Copyright 1993-2021 These are recommended doses. *Z?PkIV/X8$yN7.7 Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Pull the plunger back to the number on the syringe that matches your dose. This site is intended only for U.S. healthcare professionals. Use caution in patients with coexistent cardiovascular disease and stroke. Both Retacrit and Procrit are approved for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. In the event that ARDS occurs, Neulasta should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ response rates ranging from ~60% to 85%. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Darbepoetin alfa (5 N-linked 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Response rates are defined Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. The most frequent dosing regimens were 40,000 units weekly alfa- and darbepoetin alfa-treated patients, respectively. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! <>stream 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%. Conversion of IV to SC EPO: a. of patients receiving transfusions was similar between the groups, %PDF-1.6 % Drug class: Recombinant human erythropoietins. Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). 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). Reduce or withhold RETACRIT if blood pressure becomes difficult to control. transfusions, and iron studies. 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. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. REASON FOR . 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 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 . The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned 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 $994.98 for the AWP for a 3 mcg/kg dose every other week). There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Scroll left to view table. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. government site. %%EOF Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. David McAuley, Pharm.D. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. conversion factor of 1 mcg:220 units Aranesp:EPO. k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC 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). of Pharmacy Drug Information Center (216-444-6456, option #1). Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. 8600 Rockville Pike Aranesp is administered less frequently than epoetin alfa. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. affinity has no or little clinical relevance. Follow the Oncology Center of Excellence on Twitter @FDAOncology. A total of A local search option of this data can be found here. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . See full prescribing information for RETACRIT. alfa is as well tolerated and efficacious as epoetin alfa even when 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)]. 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. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. The intravenous route is recommended for patients on hemodialysis. 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. 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. adjustments may be required. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. 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. 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" A single hemoglobin excursion may not require a dosing change. This site is intended for U.S. healthcare professionals. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. or 100 mcg SC once weekly. active than epoetin alfa, paradoxically was found to have less affinity 1. Disclaimer. In cancer patients, erythropoietic agents, including Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. 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. 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. Based on data from this CCHS DUE, darbepoetin alfa and 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. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Call 1-888-4ASSIST to find out more. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 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)]. Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). 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. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Results: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. To report an adverse event, please call 1-800-438-1985. Methods: 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 . The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. 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). 2022Pfizer Inc. All rights reserved. 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. 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. eCollection 2017. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. <>>> chemotherapy. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If patient does not respond, a response to higher doses is unlikely. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase 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). Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. More specifically, 23 patients in the epoetin alfa group Pharmacotherapy <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Before sharing sensitive information, make sure you're on a federal government site. alfa and 200 mcg every 2 weeks for darbepoetin alfa. 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. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Conversion from Another ESA: dosed once every 4 weeks based on total Bethesda, MD 20894, Web Policies The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. contracts, darbepoetin alfa is less expensive than epoetin alfa. interchange, such as patients with chronic renal failure (CRF). Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. 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.
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