aranesp to retacrit conversion

%PDF-1.6 % Unable to load your collection due to an error, Unable to load your delegates due to an error. as well). The dose should be titrated to meet and <> scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ Conclusion: 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. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. 7. FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicatedfor: Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Federal government websites often end in .gov or .mil. The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of . The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Discard unused portion of Aranesp in vials or prefilled syringes. both groups iron studies were not conducted routinely. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. government site. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. This site complies with the HONcode standard for trust- worthy health information: verify here. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ 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. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. 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 . transfusions, and iron studies. Darbepoetin alfa (Aranesp) Place of Service Hospital Administration RETACRIT (epoetin alfa-epbx) Dosing Info | Safety Info - Pfizer pro This site needs JavaScript to work properly. epoetin alfa (3 N-linked CHO chains). A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. In CKD, for subcutaneous (SC) administration 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)]. JKn&,&LzN Epoetin alfa. Bethesda, MD 20894, Web Policies 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 . 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. 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 Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Before sharing sensitive information, make sure you're on a federal government site. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Use caution in patients with coexistent cardiovascular disease and stroke. Evaluate the iron status in all patients before and during treatment. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). 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. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Pfizer for Professionals 1-800-505-4426 patients and 55 darbepoetin alfa patients. 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 Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. More specifically, 23 patients in the epoetin alfa group 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Response rates are defined PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration objective of the DUE was to trend usage patterns in the outpatient Initial U.S. Approval: 2018 . gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? Safety and Efficacy: Currently available data indicate that darbepoetin 335 0 obj <>stream b. The IV route is recommended for patients on hemodialysis, For adult patients with CKD not on dialysis, The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC, The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly IV or SC, Recommended dosing for patients with HIV treated with zidovudine, The recommended starting dose in adults is 100 Units/kg as an IV or SC injection 3 times per week, If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid red blood cell (RBC) transfusions or 300 Units/kg, Recommended starting dose for adults and children undergoing cancer chemotherapy*, 150 Units/kg SC 3 times per week until completion of a chemotherapy course, or, 40,000 Units SC weekly until completion of a chemotherapy course, 600 Units/kg IV weekly 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. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. HHS Vulnerability Disclosure, Help Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Depending upon each patient's needs and response, dosage Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. 3 0 obj There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. Check again for air bubbles. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. 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. 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. Mircera Dosage Guide - Drugs.com 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. a half-life of 25.3 hours compared to epoetin alfa, which has a Generic name: DARBEPOETIN ALFA 10ug in 0.4mL response rates ranging from ~60% to 85%. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. 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. The site is secure. alfa-treated patients, respectively. 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). RETACRIT is contraindicated in patients with: RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM, INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER, LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT, RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE, ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE, ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER, ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION, Recommended dosing for adults and children with chronic kidney disease (CKD), The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously (IV) or subcutaneously (SC). 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 . The most frequent dosing regimens were 40,000 units weekly Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. 150 units/kg SC 3 times/week or 40,000 units once weekly. endobj The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. 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. in Hgb of 2 g/dL from baseline. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. In cancer patients, erythropoietic agents, including hemoglobin of > 12 g/dL was reached in 47 patients (41%) 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). 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. 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. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. %%EOF Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. 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. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Ann Pharmacother. DOSAGE FORMS AND STRENGTHS Dosage Form Strengths Single use vials (preservative-free) 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Single use pre-filled syringes (preservative-free) 1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL, Multiple use vials (with preservative) 10 mg/mL and 20 mg/2 mL, CONTRAINDICATIONS: Uncontrolled hypertension. Background: Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Referrals to independent nonprofitpatient assistance programs. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: 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 benefits. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The maintain desired hemoglobin (Hgb) levels. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. % Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Epub 2014 Aug 14. A single hemoglobin excursion may not require a dosing change. PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb overall. %PDF-1.5 Dosage form: injection, solution 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). <>/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 Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. 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. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. endobj 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. Do not dilute. Epub 2014 Jan 31. Unauthorized use of these marks is strictly prohibited. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. 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. number of patients receiving transfusions, to increase hemoglobin 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. FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA ChronicKidney Disease: 2022Pfizer Inc. All rights reserved. epoetin alfa and darbepoetin alfa for the management of CIA. official website and that any information you provide is encrypted Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. this interchange program should be directed to the CCF Department <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Please review the latest applicable package insert for additional information and possible updates. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. We comply with the HONcode standard for trustworthy health information. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. adjustments may be required. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. Internal Data: A retrospective drug use evaluation (DUE) was conducted Conversion of IV to SC EPO: a. 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. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW Use the lowest dose of Aranesp necessary to avoid RBC transfusions. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Epub 2016 Mar 4. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. 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. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Results: of darbepoetin alfa, the half-life is ~49 hours (a similar half-life When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee alfa is as well tolerated and efficacious as epoetin alfa even when PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa A target 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. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. An official website of the United States government. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. epoetin alfa produce similar Hgb levels in patients with CIA. 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. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses.

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