aranesp to retacrit conversion aranesp to retacrit conversion

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. Follow the Oncology Center of Excellence on Twitter @FDAOncology. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1). Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. 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 scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ 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. contracts, darbepoetin alfa is less expensive than epoetin alfa. Internal Data: A retrospective drug use evaluation (DUE) was conducted Do not dilute. Overall, in both groups iron studies were not conducted routinely. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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). Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? overall. An official website of the United States government. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. The https:// ensures that you are connecting to the Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. patients had to be initiated on epoetin alfa or darbepoetin alfa 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. 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. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). As a substitute for RBC transfusions in patients who require immediate correction of anemia. epoetin alfa produce similar Hgb levels in patients with CIA. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Do not use Aranesp that has been shaken or frozen. Ann Pharmacother. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. 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. 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 . Dr. Gerald Diaz @GeraldMD. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . If patient does not respond, a response to higher doses is unlikely. 2 0 obj 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. The site is secure. Decreases in dose can occur more frequently. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Do Not Copy, Distribute or otherwise Disseminate without express permission. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 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. If there are still air bubbles, repeat the steps above to remove them. 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). An official website of the United States government, : Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. . <>stream Federal government websites often end in .gov or .mil. %PDF-1.5 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. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Dosage form: injection, solution The .gov means its official.Federal government websites often end in .gov or .mil. Overall, only 10.5% of patients had iron studies before erythropoietin The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. 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). 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. % 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). conversion factor of 1 mcg:220 units Aranesp:EPO. 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 Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). Clipboard, Search History, and several other advanced features are temporarily unavailable. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. 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. %PDF-1.6 % 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. 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)]. The dose should be titrated to meet and in Hgb of 2 g/dL from baseline. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. of patients receiving transfusions was similar between the groups, In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Epogen is used in the dialysis area at CCF. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. <> Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. 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. 7. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned Refer to Aranesp package insert for pediatric dosing conversion. 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. Pussell BA, Walker R; Australian Renal Anaemia Group. Epub 2009 Aug 4. These are recommended 0 Call 1-888-4ASSIST to find out more. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. 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 . levels, and to improve quality of life. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. FOIA Based on data from this CCHS DUE, darbepoetin alfa and 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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. endstream 33 Dose. It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products, said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDAs Center for Drug Evaluation and Research. 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. Background: A local search option of this data can be found here. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. These are recommended doses. Conversion from Another ESA: dosed once every 4 weeks based on total Initial U.S. Approval: 2018 . 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. 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 . Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. Epoetin alfa. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Evaluation of Iron Stores and Nutritional Factors. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* However, this may result in the over treatment of uraemic anaemia. 2. Committee will be exploring other patient populations for this hemoglobin of > 12 g/dL was reached in 47 patients (41%) A target Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. 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. Would you like email updates of new search results? 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 . 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. Based on the patient's response, darbepoetin 4 x previous weekly epoetin alfa dose (Units)/125. _____ (if . 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. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. Before sharing sensitive information, make sure youre on a federal 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. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). and approved an automatic therapeutic interchange to darbepoetin Darbepoetin alfa, although several fold more biologically similar over the course of therapy for both groups. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. 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). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aranesp Dosing and Conversion Brochure. 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 Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. This site is intended for U.S. healthcare professionals. Use caution in patients with coexistent cardiovascular disease and stroke. This site needs JavaScript to work properly. Slowly push the plunger up to force the air bubbles out of the syringe. 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. The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin 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. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . While a discounted alternative to Epogen and Procrit is welcome, there is a catch. Do not mix with other drug solutions.