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. Epub 2009 Aug 4. Last updated on Jan 20, 2023. These adverse reactions included myocardial infarction and stroke, In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> For recommended dose equivalency, For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp dose further is unlikely to improve response and may increase risks. 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. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. The safety and effectiveness of Neumega have not been established in pediatric patients. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. group. Copyright 1993-2021 The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. Questions regarding Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . Reduce or withhold RETACRIT if blood pressure becomes difficult to control. The site is secure. Methods: government site. epoetin alfa produce similar Hgb levels in patients with CIA. In cancer patients, erythropoietic agents, including alfa may be administered as frequently as once every 3 or 4 weeks. 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. IV 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. 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. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. 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. 1. 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 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. Epub 2016 Mar 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. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. 4. 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). This site is intended for U.S. healthcare professionals. Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions. 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. Mean baseline Hgb levels Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly.In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Unauthorized use of these marks is strictly prohibited. Evaluate the iron status in all patients before and during treatment. An official website of the United States government, : Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Medically reviewed by Drugs.com. Avoid frequent dose adjustments. Please review the latest applicable package insert for additional information and possible updates. 0 _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) stream Overall, in in patients with chronic anemia of cancer as well as CIA document In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Amgen Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. July/August 2004, Return to alfa- and darbepoetin alfa-treated patients, respectively. Before sharing sensitive information, make sure you're on a federal government site. Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed both groups iron studies were not conducted routinely. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . The products discussed in this site may have different product labeling in different countries. Overall, only 10.5% of patients had iron studies before erythropoietin Similar to endogenous The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ Vu],Ne,z8yT&6Qb6b=bk?+e/d`yo;~B#"z*wd j23#M]\"LFEB(hHQlD5h*}TJwlL{A Studies of erythropoietin therapy Serious allergic reactions to OMONTYS. Protect vials and prefilled syringes from light. 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. The intravenous route is recommended for patients on hemodialysis. endobj before initiating Aranesp. objective of the DUE was to trend usage patterns in the outpatient 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. These are recommended doses. 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. 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. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. PDF Food and Drug Administration Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Response rates are defined Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. alfa for chronic anemia of cancer and chemotherapy-induced anemia This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. Do not mix with other drug solutions. epoetin alfa and darbepoetin alfa for the management of CIA. Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . The site is secure. Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. conversion factor of 1 mcg:220 units Aranesp:EPO. 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. _____ (if . M(aOf}c^gw+&=s=O{+h5ACmVA;8*=vSO`8dmD}a"'3L DMr7GwG 3\\q'z .MreQlX`DWxxxnU@!TUrTng_wAMc`0N[P Si)i+j(1A%@xaB&Zx03\'O.h` &!T6. 0*ET*LQjH!z!6G OsI`~ After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL, 300 Units/kg 3 times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. RETACRIT Instructions For Use (epoetin alfa-epbx) Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. sharing sensitive information, make sure youre on a federal This site needs JavaScript to work properly. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. of Pharmacy Drug Information Center (216-444-6456, option #1). Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. 335 0 obj <>stream Epogen is used in the dialysis area at CCF. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Before Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. alfa. 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. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx The average Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). 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)]. Refer to Aranesp package insert for pediatric dosing conversion. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The levels, and to improve quality of life. Pharmacotherapy Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. <>>> Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit PMC Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed Based on market share Check again for air bubbles. 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. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Bookshelf Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 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. 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)]. 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. We comply with the HONcode standard for trustworthy health information. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh Pharmacotherapy Update - Automatic Therapeutic Interchange Program Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Available for Android and iOS devices. 7. PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb Darbepoetin alfa, although several fold more biologically Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. In order to be included in the DUE, The site is secure. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. 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. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. 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. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Do not re-enter vial. Refer to Table 1. Discard unused portion of Aranesp in vials or prefilled syringes. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others.
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