2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. epoetin alfa produce similar Hgb levels in patients with CIA. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Vol. Do not dilute. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. Round the dose to the nearest treatment tier. alfa. 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. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). of darbepoetin alfa, the half-life is ~49 hours (a similar half-life
Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). In order to be included in the DUE,
Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. 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%. PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin 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. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Select one or more newsletters to continue. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Pull the plunger back to the number on the syringe that matches your dose. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. PMC Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. FDA approves first epoetin alfa biosimilar for the treatment of anemia Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. 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. 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). The site is secure. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Dr. Gerald Diaz @GeraldMD. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. 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. Bethesda, MD 20894, Web Policies <>
Federal government websites often end in .gov or .mil. 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. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. response rates ranging from ~60% to 85%. Ann Pharmacother. Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. Scroll left to view table. ChronicKidney Disease: 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. Serious allergic reactions to OMONTYS. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Depending upon each patient's needs and response, dosage adjustments may be required. Contributed by. However, this may result in the over treatment of uraemic anaemia. The optimal timing and duration of growth factor stimulation has not been determined. The majority of reported events occurred upon initial exposure. endobj
11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated
Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Unauthorized use of these marks is strictly prohibited. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). A target
Based on data from this CCHS DUE, darbepoetin alfa and
When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu Questions regarding
Nephrol Dial Transplant. An official website of the United States government, : This site needs JavaScript to work properly. (CIA) for both outpatients and inpatients. of endogenous erythropoietin may be impaired in patients receiving
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Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA Update Index. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Darbepoetin alfa. 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 . number of patients receiving transfusions, to increase hemoglobin
Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Epub 2005 Dec 6. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. 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). 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. 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. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. %PDF-1.6
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Pfizer for Professionals 1-800-505-4426 Epoetin alfa. We comply with the HONcode standard for trustworthy health information. this interchange program should be directed to the CCF Department
1022 0 obj OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. The .gov means its official.Federal government websites often end in .gov or .mil. 150 units/kg SC 3 times/week or 40,000 units once weekly. Available for Android and iOS devices. 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. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. When therapy with RETACRIT is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In controlled clinical trials of patients with chronic kidney disease (CKD) comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), epoetin alfa increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups, Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Studies of erythropoietin therapy
When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase
Drug class: Recombinant human erythropoietins. For recommended dose equivalency,
7. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Based on the patient's response, darbepoetin
*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. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Conversion from Another ESA: dosed once every 4 weeks based on total government site. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. Aranesp Dosing and Conversion Brochure. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Colony Stimulating Factors - GlobalRPH 4 x previous weekly epoetin alfa dose (Units)/125. 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: Please enable it to take advantage of the complete set of features! Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. %PDF-1.6
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Discard unused portion of Aranesp in vials or prefilled syringes. 4 0 obj
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. 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. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa 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. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. similar over the course of therapy for both groups. %%EOF 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). The safety and effectiveness of Neumega have not been established in pediatric patients. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. 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)]. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Learn how to combine multiple dosing options for precise titration and individualize anemia management. A total of
Epub 2009 Aug 4. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Careers. 1121 0 obj MeSH Disclaimer. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. This site is intended for U.S. healthcare professionals. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. 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. Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed Monitor platelets and hematocrit regularly. overall. adjustments may be required. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. The products discussed in this site may have different product labeling in different countries. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Methods: eCollection 2017. IV
Keep the tip of the needle in the RETACRIT liquid. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Epogen is used in the dialysis area at CCF. PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration alfa for chronic anemia of cancer and chemotherapy-induced anemia
The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
Results: 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 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. 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. patients had to be initiated on epoetin alfa or darbepoetin alfa
before initiating Aranesp. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh 1. 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 . Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. In the near future, the Pharmacy and Therapeutics
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. 1 0 obj
The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Epogen (Amgen), another brand name for epoetin
Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. 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. 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. HrsW-D/tCPs. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. endobj
All Rights Reserved. The implementation date for the interchange program is October 11, 2004. 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. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. 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. 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`~ The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 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. 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). To report an adverse event, please call 1-800-438-1985. 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. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. The site is secure. 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. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Slowly push the plunger up to force the air bubbles out of the syringe. epoetin alfa and darbepoetin alfa for the management of CIA. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. 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. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. Accessibility Discontinue Aranesp if responsiveness does not improve. Depending upon each patient's needs and response, dosage
Hgb level. of patients receiving transfusions was similar between the groups,
for at least 3 weeks between July 2002 and July 2003. interchange, such as patients with chronic renal failure (CRF). 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. Retacrit has been approved as a biosimilar, not as an interchangeable product. alfa is as well tolerated and efficacious as epoetin alfa even when
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. 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)]. 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. REASON FOR . Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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. as well). 33 Dose. 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. for the erythropoietin receptors, suggesting the slower clearance
Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Last updated on Jan 20, 2023. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Nephrology (Carlton). half-life of 8.5 hours. *Z?PkIV/X8$yN7.7 hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. The average
Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW