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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`~ 7. 4 0 obj Aranesp (darbepoetin alfa) | Dosing Considerations For recommended dose equivalency, Retacrit has been approved as a biosimilar, not as an interchangeable product. <> The dose should be titrated to meet and Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. Darbepoetin alfa. In the near future, the Pharmacy and Therapeutics of the molecule is a more important determinant of potency and receptor Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Monitor platelets and hematocrit regularly. similar over the course of therapy for both groups. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Mean baseline Hgb levels Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Evaluate the iron status in all patients before and during treatment. 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. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Darbepoetin alfa (5 N-linked An official website of the United States government, : 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. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Studies of erythropoietin therapy EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Results: Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. maintain desired hemoglobin (Hgb) levels. 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. 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). What is the difference between Retacrit and Procrit? - Drugs.com 2. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. INDICATIONS AND USAGE: 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZARXIO is indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1)]. startxref Pharmacotherapy The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. We comply with the HONcode standard for trustworthy health information. 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. Would you like email updates of new search results? *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. . scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. Scroll left to view table. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed Wien Med Wochenschr. epoetin alfa and darbepoetin alfa for the management of CIA. Careers. 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. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin 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. Pull the plunger back to the number on the syringe that matches your dose. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* official website and that any information you provide is encrypted 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. Epub 2004 Feb 19. 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. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu Woodland AL, Murphy SW, Curtis BM, Barrett BJ. The .gov means its official. 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. endobj REASON FOR . 1. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. both groups iron studies were not conducted routinely. alfa-treated patients, respectively. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or 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). Referrals to independent nonprofitpatient assistance programs. A total of Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. 1121 0 obj Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. Do not re-enter vial. 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. levels, and to improve quality of life. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Committee will be exploring other patient populations for this 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. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Based on the patient's response, darbepoetin 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. Table 1. 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. 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). Pharmacotherapy Update - Automatic Therapeutic Interchange Program Based on data from this CCHS DUE, darbepoetin alfa and 2 0 obj a half-life of 25.3 hours compared to epoetin alfa, which has a A target alfa and 200 mcg every 2 weeks for darbepoetin alfa. (CIA) for both outpatients and inpatients. The information provided is for educational purposes only. patients and 55 darbepoetin alfa patients. This site is intended for U.S. healthcare professionals. 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). overall. The FDAs approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit.