More specifically, 23 patients in the epoetin alfa group Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. 3 0 obj 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Epub 2016 Mar 4. HrsW-D/tCPs. Epub 2014 Aug 14. alfa. % Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. of the molecule is a more important determinant of potency and receptor Depending upon each patient's needs and response, dosage adjustments may be required. %PDF-1.5 GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. If patient does not respond, a response to higher doses is unlikely. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. hemoglobin of > 12 g/dL was reached in 47 patients (41%) Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. (CIA) for both outpatients and inpatients. To report an adverse event, please call 1-800-438-1985. Please review the latest applicable package insert for additional information and possible updates. 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). 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). 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. Nephrol Dial Transplant. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. 1 0 obj Background Anaemia is defined as a reduction of haemoglobin concentration, red . Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. !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! endobj Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. The number PMC Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). These are recommended doses. Careers. Pfizer for Professionals 1-800-505-4426 OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Committee will be exploring other patient populations for this "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* 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. 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. INDICATIONS AND USAGE Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. 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). This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. and approved an automatic therapeutic interchange to darbepoetin government site. 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. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. 4 0 obj Based on data from this CCHS DUE, darbepoetin alfa and 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. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. The FDAs approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. objective of the DUE was to trend usage patterns in the outpatient 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. Epoetin alfa. IL-11 has also been shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. 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. In CKD, for subcutaneous (SC) administration 150 units/kg SC 3 times/week or 40,000 units once weekly. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Aranesp Dosing and Conversion Brochure. W bO? Unauthorized use of these marks is strictly prohibited. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. . Adult Respiratory Distress Syndrome (ARDS) Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. 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 majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. a half-life of 25.3 hours compared to epoetin alfa, which has a Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). 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 initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Drug class: Recombinant human erythropoietins. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. The probability of switching between different epoetins was associated with the duration of treatment: about 15 % of users switched within 12 months and almost 25 % within 2 years of observation. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. The https:// ensures that you are connecting to the 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. alfa-treated patients, respectively. 4 x previous weekly epoetin alfa dose (Units)/125. FOIA 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: 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 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. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. 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. Vol. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? The site is secure. However, this may result in the over treatment of uraemic anaemia. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. A single hemoglobin excursion may not require a dosing change. 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. Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Medically reviewed by Drugs.com. 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. Epogen (Amgen), another brand name for epoetin 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. In the near future, the Pharmacy and Therapeutics EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. 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. 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). JKn&,&LzN Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Darbepoetin alfa. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. overall. May 15, 2018. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Protect vials and prefilled syringes from light. 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. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . 2 0 obj hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. This site complies with the HONcode standard for trust- worthy health information: verify here. Pussell BA, Walker R; Australian Renal Anaemia Group. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. 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. Refer to Aranesp package insert for pediatric dosing conversion. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. alfa is as well tolerated and efficacious as epoetin alfa even when _____ (if . dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week 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)]. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. endobj Overall, only 10.5% of patients had iron studies before erythropoietin Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Slowly push the plunger up to force the air bubbles out of the syringe. 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. 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. Keep the tip of the needle in the RETACRIT liquid. 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. <> 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. alfa (Aranesp; Amgen) to be therapeutic equivalent products Epub 2005 Dec 6. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. this interchange program should be directed to the CCF Department Please enable it to take advantage of the complete set of features! patients and 55 darbepoetin alfa patients. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . The .gov means its official. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. *Z?PkIV/X8$yN7.7 It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u 1. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . Existing patients on IV EPO, change to subcutaneous EPO using the . . Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Before Use caution in patients with coexistent cardiovascular disease and stroke. of endogenous erythropoietin may be impaired in patients receiving An official website of the United States government, : Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Dosage form: injection, solution epoetin alfa and darbepoetin alfa, have been shown to decrease the Bookshelf PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. Hgb level. <> Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). before initiating Aranesp. Pull the plunger back to the number on the syringe that matches your dose. A total of 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. doses. 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. Overall, in 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). Discontinue Aranesp if responsiveness does not improve. Contributed by. 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. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Do not dilute. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. endstream Bethesda, MD 20894, Web Policies The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg.

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