An official website of the United States government, : a half-life of 25.3 hours compared to epoetin alfa, which has a The information provided is for educational purposes only. <> 8600 Rockville Pike 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. The majority of reported events occurred upon initial exposure. epoetin alfa produce similar Hgb levels in patients with CIA. 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. Accessibility epoetin alfa and darbepoetin alfa for the management of CIA. Aranesp Dosing and Conversion Brochure. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. . similar over the course of therapy for both groups. 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. 1 0 obj IV Do not increase the dose more frequently than once every 4 weeks. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. The https:// ensures that you are connecting to the Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . alfa is as well tolerated and efficacious as epoetin alfa even when This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. An official website of the United States government. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. Maintain the route of administration (intravenous or subcutaneous injection). 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. Epogen is used in the dialysis area at CCF. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. Aranesp is administered less frequently than epoetin alfa. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. as well). Learn how to combine multiple dosing options for precise titration and individualize anemia management. 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. In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. The site is secure. 1121 0 obj This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. However, this may result in the over treatment of uraemic anaemia. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. The .gov means its official. Bethesda, MD 20894, Web Policies When therapy with RETACRITis needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy, In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure, In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion, In patients scheduled for surgery who are willing to donate autologous blood, In patients undergoing cardiac or vascular surgery, As a substitute for RBC transfusions in patients who require immediate correction of anemia, Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs, Serious allergic reactions to RETACRIT or other epoetin alfa products, Neonates, infants, pregnant women, and lactating women. alfa-treated patients, respectively. 335 0 obj <>stream startxref PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration endstream (CKD) patients, darbepoetin alfa administered intravenously has 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. 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. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Use caution in patients with coexistent cardiovascular disease and stroke. This site needs JavaScript to work properly. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. 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. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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. INDICATIONS AND USAGE Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. PDF Food and Drug Administration 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. ChronicKidney Disease: Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). alfa- and darbepoetin alfa-treated patients, respectively. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. Check again for air bubbles. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Slowly push the plunger up to force the air bubbles out of the syringe. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. before initiating Aranesp. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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). Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. 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. Vol. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. We comply with the HONcode standard for trustworthy health information. FOIA 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. 1. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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). Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. adjustments may be required. Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Serious allergic reactions to OMONTYS. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? of darbepoetin administered SC has been shown in cancer patients affinity has no or little clinical relevance. %PDF-1.6 % RETACRIT single-dose vials contain phenylalanine, a component of aspartame. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. In addition, at this time, this interchange program does not affect OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human .
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