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 . 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. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. A local search option of this data can be found here. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Please review the latest applicable package insert for additional information and possible updates. 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. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. Discard unused portion of Aranesp in vials or prefilled syringes. HHS Vulnerability Disclosure, Help Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . 335 0 obj
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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. 2 0 obj
e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. All Rights Reserved. transfusions, and iron studies. %PDF-1.6
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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. Epogen is used in the dialysis area at CCF. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. as well). alfa (Aranesp; Amgen) to be therapeutic equivalent products
Epub 2004 Feb 19. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. 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. <>stream
Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. alfa is as well tolerated and efficacious as epoetin alfa even when
Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. 2. 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. epoetin alfa produce similar Hgb levels in patients with CIA. Avoid frequent dose adjustments. Conversion of IV to SC EPO: a. Based on the patient's response, darbepoetin
If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. overall. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. 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. The site is secure. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase
In addition, at this time, this interchange program does not affect
After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue 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. Drug class: Recombinant human erythropoietins. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency, For lack or loss of hemoglobin response to RETACRIT, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding). This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 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. half-life of 8.5 hours. Response rates are defined
RETACRIT safely and effectively.
FDA approves first epoetin alfa biosimilar for the treatment of anemia See full prescribing information for RETACRIT.
(PDF) Conversion from epoetin beta to darbepoetin: What is the The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU).
PDF Food and Drug Administration Monitor platelets and hematocrit regularly. Refer to Aranesp package insert for pediatric dosing conversion. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. <> Based on data from this CCHS DUE, darbepoetin alfa and
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 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).
Darbepoetin alfa (Aranesp) Place of Service Hospital Administration This site is intended for U.S. healthcare professionals. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Bethesda, MD 20894, Web Policies 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. Internal Data: A retrospective drug use evaluation (DUE) was conducted
7. Round the dose to the nearest treatment tier. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. 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. Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary to treat anemia associated with myelodysplastic syndromes when the following criteria are met: 2, 3,8,9,32,46 . Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. Hgb level. Key: Hgb = hemoglobin level, measured in . Mean baseline Hgb levels
chemotherapy.
PDF Home Dialysis Programs Standing Orders - Erythropoietin Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Results: Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. Would you like email updates of new search results? Follow the Oncology Center of Excellence on Twitter @FDAOncology. . 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. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa
Referrals to independent nonprofitpatient assistance programs. Accessibility The
Slowly push the plunger up to force the air bubbles out of the syringe. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Existing patients on IV EPO, change to subcutaneous EPO using the . 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. These are recommended doses. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. every-other-week) for darbepoetin alfa-treated patients. 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. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 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)]? Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Careers. !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X
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Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. Refer to Table 1. 4 x previous weekly epoetin alfa dose (Units)/125. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. 1057 0 obj In addition, Hgb levels were
Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Do not increase the dose more frequently than once every 4 weeks. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. 4.
FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx Overall, only 10.5% of patients had iron studies before erythropoietin
2022Pfizer Inc. All rights reserved. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. 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. of darbepoetin administered SC has been shown in cancer patients
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Immediately and permanently discontinue RETACRIT and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs, Blistering and skin exfoliation reactions, including erythema multiforme and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported in patients treated with ESAs (including epoetin alfa) in the postmarketing setting. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast.
Pharmacotherapy Update - Automatic Therapeutic Interchange Program Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease.
PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit of the molecule is a more important determinant of potency and receptor
(CIA) for both outpatients and inpatients. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life
response rates ranging from ~60% to 85%. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Do Not Copy, Distribute or otherwise Disseminate without express permission. 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. Scroll left to view table. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN
$l-FRW+>U0pPhRc/N
R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" for the erythropoietin receptors, suggesting the slower clearance
G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. endobj
Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ
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Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. Conversion from Another ESA: dosed once every 4 weeks based on total Pull the plunger back to the number on the syringe that matches your dose. Last updated on Jan 20, 2023. An official website of the United States government, : "9hu2,yUHZC]r}P(j 5{O$Mv$5O6
r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. maintain desired hemoglobin (Hgb) levels. 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)]. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. %PDF-1.6
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Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? 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. 1.5 Patients with Severe Chronic Neutropenia ZARXIO is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g. fever infections oropharyngeal ulcers) in symptomatic patients with congenital neutropenia cyclic neutropenia or idiopathic neutropenia, HOW SUPPLIED: Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard. 8600 Rockville Pike
Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Safety and Efficacy: Currently available data indicate that darbepoetin
doses. Vol. Following initiation and titration of epoetin alfa, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving RETACRIT, Appropriately control hypertension prior to initiation of and during treatment with RETACRIT. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. <>/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
Switch from epoetin to darbepoetin alfa in hemodialysis: dose of endogenous erythropoietin may be impaired in patients receiving
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). 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). Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. MeSH Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . most common dosing regimens are 40,000 units weekly for epoetin
Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. endobj
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)].
RETACRIT Instructions For Use (epoetin alfa-epbx) This site complies with the HONcode standard for trust- worthy health information: verify here. Epogen (Amgen), another brand name for epoetin
Use caution in patients with coexistent cardiovascular disease and stroke. epoetin alfa (3 N-linked CHO chains). Pharmacotherapy
Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Available for Android and iOS devices.
Aranesp | European Medicines Agency Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Depending upon each patient's needs and response, dosage
G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa.
PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa