administered less frequently. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB 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%. Safety and Efficacy: Currently available data indicate that darbepoetin Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Evaluate the iron status in all patients before and during treatment. Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis, Adverse reactions in 5% of epoetin alfa-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation. All Rights Reserved. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: The implementation date for the interchange program is October 11, 2004. 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. Evaluation of Iron Stores and Nutritional Factors. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. If hemoglobin increases greater than 1 g/dL in any 2-week period or, If hemoglobin reaches a level needed to avoid RBC transfusion, Withhold dose until hemoglobin approaches a level where RBC transfusions may be required, Reinitiate at a dose 40% below the previous dose, If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy, Following completion of a chemotherapy course. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 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. 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. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. Similar to endogenous Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. alfa for chronic anemia of cancer and chemotherapy-induced anemia The site is secure. or 100 mcg SC once weekly. Wien Med Wochenschr. patients and 55 darbepoetin alfa patients. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? epoetin alfa and darbepoetin alfa for the management of CIA. 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)]. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Epub 2004 Feb 19. Darbepoetin alfa (5 N-linked Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. (CKD) patients, darbepoetin alfa administered intravenously has Please enable it to take advantage of the complete set of features! The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). 8600 Rockville Pike zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. epoetin alfa (3 N-linked CHO chains). The safety and effectiveness of Neumega have not been established in pediatric patients. A total of Use the lowest dose of Aranesp necessary to avoid RBC transfusions. 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. Existing patients on IV EPO, change to subcutaneous EPO using the . in patients with chronic anemia of cancer as well as CIA document The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. 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)]. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. In CKD, for subcutaneous (SC) administration 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). endobj 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. 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 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. Please review the latest applicable package insert for additional information and possible updates. July/August 2004, Return to in Hgb of 2 g/dL from baseline. Protect vials and prefilled syringes from light. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. 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. Retacrit has been approved as a biosimilar, not as an interchangeable product. <>/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 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. 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. 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. endobj RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Select one or more newsletters to continue. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. of patients receiving transfusions was similar between the groups, e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves Retacrit as a biosimilar to Epogen/Procrit, Drug Information Soundcast in Clinical Oncology. Overall, only 10.5% of patients had iron studies before erythropoietin patients had to be initiated on epoetin alfa or darbepoetin alfa transfusions, and iron studies. In pediatric patients, Mircera is administered by intravenous injection only (2.2). eCollection 2017. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 The dose should be titrated to meet and 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. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. We comply with the HONcode standard for trustworthy health information. arena for dosing, dosing interval, hemoglobin levels, number of Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. In order to be included in the DUE, 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. %PDF-1.6 % Epogen is used in the dialysis area at CCF. JKn&,&LzN ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 4. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. 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 . dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or 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. Drug class: Recombinant human erythropoietins. doses. The most frequent dosing regimens were 40,000 units weekly Generic name: DARBEPOETIN ALFA 10ug in 0.4mL A target Woodland AL, Murphy SW, Curtis BM, Barrett BJ. 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)]. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Nephrol Dial Transplant. %PDF-1.5 Use caution in patients with coexistent cardiovascular disease and stroke. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. both groups iron studies were not conducted routinely. of the molecule is a more important determinant of potency and receptor 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. Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. 1. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Darbepoetin alfa, although several fold more biologically 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). ChronicKidney Disease: "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). chemotherapy. 335 0 obj <>stream The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. erythropoietin, darbepoetin alfa stimulates erythropoiesis. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. . 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. 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. The site is secure. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Background: endstream endobj 336 0 obj <>stream Unauthorized use of these marks is strictly prohibited. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> objective of the DUE was to trend usage patterns in the outpatient The recommended starting Darbepoetin alfa. Pull the plunger back to the number on the syringe that matches your dose. In patients receiving treatment for cancer and whose anemia is not due to CKD. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. In addition, Hgb levels were Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 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. 4. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. In addition, at this time, this interchange program does not affect *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. active than epoetin alfa, paradoxically was found to have less affinity 4 0 obj Avoid frequent dose adjustments. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). and approved an automatic therapeutic interchange to darbepoetin Based on data from this CCHS DUE, darbepoetin alfa and Federal government websites often end in .gov or .mil. The site is secure. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. The https:// ensures that you are connecting to the A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. Mean baseline Hgb levels Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. endobj Do not dilute. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. 33 Dose. 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. Epoetin alfa. levels, and to improve quality of life. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. this interchange program should be directed to the CCF Department
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