Check again for air bubbles. 33 Dose. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. 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. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Retacrit has been approved as a biosimilar, not as an interchangeable product. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. 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. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. 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 the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Epub 2005 Dec 6. 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. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. both groups iron studies were not conducted routinely. Dosage form: injection, solution this interchange program should be directed to the CCF Department Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. RETACRIT (epoetin alfa-epbx) Dosing Info | Safety Info - Pfizer pro Study of Transplant Related Anemia Treated With Aranesp (STRATA Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 microg/week (P = 0.02). 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. Call 1-888-4ASSIST to find out more. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Refer to Aranesp package insert for pediatric dosing conversion. eCollection 2017. Internal Data: A retrospective drug use evaluation (DUE) was conducted overall. Conclusion: An official website of the United States government. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Do not increase the dose more frequently than once every 4 weeks. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Before sharing sensitive information, make sure you're on a federal government site. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin The site is secure. 150 units/kg SC 3 times/week or 40,000 units once weekly. See full prescribing information for RETACRIT. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin Methods: 0 If there are still air bubbles, repeat the steps above to remove them. 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. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) The site is secure. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. of endogenous erythropoietin may be impaired in patients receiving as well). EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . 2. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. affinity has no or little clinical relevance. endobj Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Mircera Dosage Guide - Drugs.com Vol. 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. David McAuley, Pharm.D. 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. 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). Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. 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. Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed RETACRIT Dosage and Administration (epoetin alfa-epbx) In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. 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. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Table 1. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. Wien Med Wochenschr. Depending upon each patient's needs and response, dosage adjustments may be required. Select one or more newsletters to continue. Results: Pharmacotherapy Update - Automatic Therapeutic Interchange Program For recommended dose equivalency, 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 https:// ensures that you are connecting to the (PDF) Conversion from epoetin beta to darbepoetin: What is the 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)]. for the erythropoietin receptors, suggesting the slower clearance Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. These are recommended doses. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. Production Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). levels, and to improve quality of life. 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. 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. Epub 2014 Jan 31. k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Conversion from Another ESA: dosed once every 4 weeks based on total VII, No. Depending upon each patient's needs and response, dosage Before sharing sensitive information, make sure you're on a federal government site. 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. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. 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. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa 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. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. PDF Highlights of Prescribing Information ----------------------- Dosage Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Evaluate the iron status in all patients before and during treatment. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa 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. Evaluate other causes of anemia. 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. see Tables A and B (below). HrsW-D/tCPs. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. 4. Epogen (Amgen), another brand name for epoetin 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 Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u at the Cleveland Clinic Health System (CCHS) reviewing the use of The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Do not use Aranesp that has been shaken or frozen. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase 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. objective of the DUE was to trend usage patterns in the outpatient Evaluate the iron status in all patients before and during treatment. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. In chronic kidney disease The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Based on data from this CCHS DUE, darbepoetin alfa and Federal government websites often end in .gov or .mil. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. If patient does not respond, a response to higher doses is unlikely. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim.