DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. Epogen (Amgen), another brand name for epoetin Overall, in both groups iron studies were not conducted routinely. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Check again for air bubbles. Pharmacotherapy All Rights Reserved. Before sharing sensitive information, make sure you're on a federal government site. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Epoetin alfa. Coverage Limitations Treatment with Darbepoetin alfa (Aranesp), Epoetin alfa (Procrit), Epoetin alfa (Epogen), and Epoetin alfa-epbx (Retacrit) is not considered medically necessary for members with the following concomitant conditions: Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Do not use Aranesp that has been shaken or frozen. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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 . Chronic Kidney Disease: 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. 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. government site. Careers. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . *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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Key: Hgb = hemoglobin level, measured in . Safety and Efficacy: Currently available data indicate that darbepoetin After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL, 300 Units/kg 3 times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. Patients on Cancer Chemotherapy 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. % 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)]. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or The intravenous route is recommended for patients on hemodialysis. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. 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. National Library of Medicine Keep the tip of the needle in the RETACRIT liquid. Results: Please enable it to take advantage of the complete set of features! b. Ann Pharmacother. 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 . Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. response rates ranging from ~60% to 85%. Dr. Gerald Diaz @GeraldMD. In addition, Hgb levels were were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage. In CKD, for subcutaneous (SC) administration Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. 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. %PDF-1.6 % conversion factor of 1 mcg:220 units Aranesp:EPO. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. . REASON FOR . Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. RETACRIT is a registered trademark of Pfizer Inc. Epogen is a registered trademark of Amgen Inc. Procrit is a registered trademark of Janssen Products, LP. of Pharmacy Drug Information Center (216-444-6456, option #1). Conclusion: and transmitted securely. or 100 mcg SC once weekly. Maintain the route of administration (intravenous or subcutaneous injection). Committee will be exploring other patient populations for this 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. The https:// ensures that you are connecting to the Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. endstream endobj 336 0 obj <>stream MeSH endobj [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. alfa- and darbepoetin alfa-treated patients, respectively. Recommended regimens for patients undergoing elective, noncardiac, nonvascular surgery, 300 Units/kg per day SC for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery, 600 Units/kg SC in 4 doses, administered 21, 14, and 7 days before surgery and on the day of surgery. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. 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. endobj For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g . Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. 1. 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. Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. as well). The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). alfa and 200 mcg every 2 weeks for darbepoetin alfa. Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. of darbepoetin administered SC has been shown in cancer patients 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). Background Anaemia is defined as a reduction of haemoglobin concentration, red . Evaluate the iron status in all patients before and during treatment. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Discard unused portion of Aranesp in vials or prefilled syringes. If there are still air bubbles, repeat the steps above to remove them. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. The .gov means its official. The recommended starting This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 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. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Bookshelf 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