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 . The recommended starting Immediately and permanently discontinue RETACRIT and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs, Blistering and skin exfoliation reactions, including erythema multiforme and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported in patients treated with ESAs (including epoetin alfa) in the postmarketing setting. Do not use Aranesp that has been shaken or frozen. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Aranesp | European Medicines Agency 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin group. PDF Highlights of Prescribing Information ----------------------- Dosage 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. FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed 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. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. 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 kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. . 0 RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . 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. Conversion of IV to SC EPO: a. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 1 0 obj 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. Careers. Both Hb and ferritin concentrations remained within the target range, but darbepoetin dosages fell from 50.8 to 42.3 microg/week by month 3 (P = 0.02). Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin patients and 55 darbepoetin alfa patients. 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. 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 . Do not dilute. Do not re-enter vial. The site is secure. Bone marrow transplantation: 5-10 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of neutropenia; recommended steps based on neutrophil response: When ANC >1000/mm3 for 3 consecutive days: Reduce filgrastim dose to 5 mcg/kg/day If ANC remains >1000/mm3 for 3 more consecutive days: Discontinue filgrastim If ANC decreases to <1000/mm3 : Resume at 5 mcg/kg/day If ANC decreases <1000/mm3 during the 5 mcg/kg/day dose, increase filgrastim to 10 mcg/kg/day and follow the above steps. 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 safety and effectiveness of Neumega have not been established in pediatric patients. Call 1-888-4ASSIST to find out more. Use caution in patients with coexistent cardiovascular disease and stroke. 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). Conclusion: 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). 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. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. In patients receiving treatment for cancer and whose anemia is not due to CKD. objective of the DUE was to trend usage patterns in the outpatient All Rights Reserved. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. The *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. 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). In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. However, this may result in the over treatment of uraemic anaemia. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Vol. Clipboard, Search History, and several other advanced features are temporarily unavailable. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . RETACRIT (epoetin alfa-epbx) Dosing Info | Safety Info - Pfizer pro 4. endobj Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. The optimal timing and duration of growth factor stimulation has not been determined. government site. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. If there are still air bubbles, repeat the steps above to remove them. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. 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. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW Production of darbepoetin alfa, the half-life is ~49 hours (a similar half-life Nephrol Dial Transplant. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. Aranesp Dosage Guide - Drugs.com Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). alfa- and darbepoetin alfa-treated patients, respectively. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. In order to be included in the DUE, Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. In the near future, the Pharmacy and Therapeutics 150 units/kg SC 3 times/week or 40,000 units once weekly. Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp dose further is unlikely to improve response and may increase risks. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . This site complies with the HONcode standard for trust- worthy health information: verify here. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. 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. The probability of switching between different epoetins was associated with the duration of treatment: about 15 % of users switched within 12 months and almost 25 % within 2 years of observation. 1022 0 obj Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . _____ (if . epoetin alfa and darbepoetin alfa, have been shown to decrease the 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.
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