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. response rates ranging from ~60% to 85%. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. 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. HrsW-D/tCPs. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. 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. 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. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Darbepoetin alfa (5 N-linked Pull the plunger back to the number on the syringe that matches your dose. objective of the DUE was to trend usage patterns in the outpatient Epogen is used in the dialysis area at CCF. therapy. Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. chemotherapy. Before sharing sensitive information, make sure you're on a federal government site. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Monitor platelets and hematocrit regularly. W bO? The site is secure. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Evaluate the iron status in all patients before and during treatment. stream _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) 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 . Available for Android and iOS devices. 0 This site needs JavaScript to work properly. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. Overall, in Epub 2005 Dec 6. The site is secure. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. Refer to Table 1. erythropoietin, darbepoetin alfa stimulates erythropoiesis. 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). Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. 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)]. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Unable to load your collection due to an error, Unable to load your delegates due to an error. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. 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. 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. 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). Drug class: Recombinant human erythropoietins. 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 . 2 0 obj Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. 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 https:// ensures that you are connecting to the 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. interchange, such as patients with chronic renal failure (CRF). Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. 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). Overall, in both groups iron studies were not conducted routinely. 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. % Epub 2016 Mar 4. Darbepoetin alfa. 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. An official website of the United States government. 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. Background Anaemia is defined as a reduction of haemoglobin concentration, red . adjustments may be required. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Evaluate the iron status in all patients before and during treatment. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. Medically reviewed by Drugs.com. alfa- and darbepoetin alfa-treated patients, respectively. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. Slowly push the plunger up to force the air bubbles out of the syringe. Do not re-enter vial. 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. of darbepoetin administered SC has been shown in cancer patients epoetin alfa and darbepoetin alfa, have been shown to decrease the Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. 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. Would you like email updates of new search results? In chronic kidney disease patients and 55 darbepoetin alfa patients. Results: -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ 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 treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. 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). <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Conclusion: Background: When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. 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. 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. 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: <>stream 33 Dose. Committee will be exploring other patient populations for this at the Cleveland Clinic Health System (CCHS) reviewing the use of This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 2. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Copyright 1993-2021 in patients with chronic anemia of cancer as well as CIA document 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 . Last updated on Jan 20, 2023. Aranesp is administered less frequently than epoetin alfa. Do Not Copy, Distribute or otherwise Disseminate without express permission. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. 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 . 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.