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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. similar over the course of therapy for both groups. alfa is as well tolerated and efficacious as epoetin alfa even when This site complies with the HONcode standard for trust- worthy health information: verify here. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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). Chronic Kidney Disease: 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. The site is secure. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disease should prescribe Neulasta for such patients, and only after careful consideration of the potential risks and benefits. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. 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. 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. hemoglobin of > 12 g/dL was reached in 47 patients (41%) Reduce or withhold RETACRIT if blood pressure becomes difficult to control. 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. Aranesp Dosing and Conversion Brochure. 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. endobj Before sharing sensitive information, make sure you're on a federal government site. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. and 24 patients in the darbepoetin alfa group reached the targeted : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Discard unused portion of Aranesp in vials or prefilled syringes. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. official website and that any information you provide is encrypted Learn how to combine multiple dosing options for precise titration and individualize anemia management. Conclusion: Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. Disclaimer. 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. transfusions, and iron studies. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 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). After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Bookshelf 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. in patients with chronic anemia of cancer as well as CIA document Do not use Aranesp that has been shaken or frozen. Depending upon each patient's needs and response, dosage adjustments may be required. 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). Medically reviewed by Drugs.com. Existing patients on IV EPO, change to subcutaneous EPO using the . dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week alfa- and darbepoetin alfa-treated patients, respectively. k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC 7/2021: added Epogen (nonformulary). endobj PMC 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. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. 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%. 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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. b. epoetin alfa and darbepoetin alfa for the management of CIA. both groups iron studies were not conducted routinely. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. Use caution in patients with coexistent cardiovascular disease and stroke. 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 . 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. 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. 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. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. In the event that ARDS occurs, Neulasta should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned Questions regarding An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first epoetin alfa biosimilar for the treatment of anemia, FDA: Office of Hematology and Oncology Products. contracts, darbepoetin alfa is less expensive than epoetin alfa. <> Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. National Library of Medicine As a substitute for RBC transfusions in patients who require immediate correction of anemia. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. most common dosing regimens are 40,000 units weekly for epoetin Protect vials and prefilled syringes from light. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Production alfa and 200 mcg every 2 weeks for darbepoetin alfa. in Hgb of 2 g/dL from baseline. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. If patient does not respond, a response to higher doses is unlikely. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Please review the latest applicable package insert for additional information and possible updates. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Epub 2009 Aug 4. *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. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 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. patients and 55 darbepoetin alfa patients. A target . EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Based on the patient's response, darbepoetin Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. 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. All Rights Reserved. The site is secure. Monitor platelets and hematocrit regularly. 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 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. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 However, this may result in the over treatment of uraemic anaemia. Hgb level. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> The https:// ensures that you are connecting to the eCollection 2017. 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). Last updated on Jan 20, 2023. Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. A single hemoglobin excursion may not require a dosing change. of endogenous erythropoietin may be impaired in patients receiving Epub 2016 Mar 4. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. and transmitted securely. chemotherapy. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Avoid frequent dose adjustments. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. These are recommended doses. Can J Kidney Health Dis. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Careers. Do not mix with other drug solutions. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Patient treatments were converted from subcutaneous epoetin alfa to weekly, intravenous darbepoetin alfa at month 0, at a conversion dose of 200 units epoetin alfa to 1 microg darbepoetin. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. 3 0 obj Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human . Epub 2014 Jan 31. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. <>>> Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, and 40,000 Units of epoetin alfa-epbx injection contains 0.5 mg of phenylalanine. This site is intended for U.S. healthcare professionals. of darbepoetin administered SC has been shown in cancer patients 1. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. Neulasta should not be used for PBPC mobilization. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Safety and Efficacy: Currently available data indicate that darbepoetin 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. 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