aranesp to retacrit conversion

Background: Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. VII, No. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. 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. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. for at least 3 weeks between July 2002 and July 2003. erythropoietin, darbepoetin alfa stimulates erythropoiesis. 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: The .gov means its official.Federal government websites often end in .gov or .mil. as well). 33 Dose. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Drug class: recombinant human erythropoietins, Aranesp (Darbepoetin Alfa Prefilled Syringes), Anemia Associated with Chronic Renal Failure, If hemoglobin exceeds a level needed to avoid RBC transfusion, If hemoglobin increases by less than 1 g/dL. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. Evaluate other causes of anemia. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . <> Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. response rates ranging from ~60% to 85%. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Conversion from Another ESA: dosed once every 4 weeks based on total Do not dilute Aranesp and do not administer in conjunction with other drug solutions. 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. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. 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 Pussell BA, Walker R; Australian Renal Anaemia Group. 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. Nephrol Dial Transplant. 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. Hgb level. k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. . It is used in two groups of patients: adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly); adults who are receiving chemotherapy for nonmyeloid cancer (cancer not originating in . Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Neulasta should not be used for PBPC mobilization. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* most common dosing regimens are 40,000 units weekly for epoetin If patient does not respond, a response to higher doses is unlikely. Conclusion: This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. and 24 patients in the darbepoetin alfa group reached the targeted a half-life of 25.3 hours compared to epoetin alfa, which has a Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, and 40,000 Units of epoetin alfa-epbx injection contains 0.5 mg of phenylalanine. To report an adverse event, please call 1-800-438-1985. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. 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. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage. Federal government websites often end in .gov or .mil. Maintain the route of administration (intravenous or subcutaneous injection). or 100 mcg SC once weekly. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Discard unused portion of Aranesp in vials or prefilled syringes. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Can J Kidney Health Dis. 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). 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated The optimal timing and duration of growth factor stimulation has not been determined. every-other-week) for darbepoetin alfa-treated patients. 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. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. An official website of the United States government. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. Would you like email updates of new search results? Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). (CIA) for both outpatients and inpatients. Do not mix with other drug solutions. and approved an automatic therapeutic interchange to darbepoetin Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. in Hgb of 2 g/dL from baseline. adjustments may be required. *Z?PkIV/X8$yN7.7 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. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. 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 . Epub 2004 Feb 19. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. 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). alfa-treated patients, respectively. 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. ChronicKidney Disease: Pull the plunger back to the number on the syringe that matches your dose. Do not dilute. 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. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. 8600 Rockville Pike Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. see Tables A and B (below). If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. Excessive response: Hemoglobin increases >1 g/dL in any 2-week period: Decrease dose Hemoglobin increases and approaches the target value of 12 g/dL: Decrease weekly dosage by ~25%. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. Bethesda, MD 20894, Web Policies Depending upon each patient's needs and response, dosage adjustments may be required. affinity has no or little clinical relevance. alfa is as well tolerated and efficacious as epoetin alfa even when The recommended starting When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. MeSH For recommended dose equivalency, 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. Medically reviewed by Drugs.com. 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. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). IL-11 has also been shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. Aranesp is the only long-acting erythropoiesis-stimulating agent (ESA) approved for both once weekly (QW) and once every three weeks (Q3W) dosing 1, 2 Aranesp dosing options of QW or Q3W may allow for synchronization with common myelosuppressive chemotherapy regimens. The number 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. endobj Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 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. 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. Round the dose to the nearest treatment tier. alfa (Aranesp; Amgen) to be therapeutic equivalent products OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). The https:// ensures that you are connecting to the Conversion of IV to SC EPO: a. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Do Not Copy, Distribute or otherwise Disseminate without express permission. These are recommended 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. Disclaimer. alfa for chronic anemia of cancer and chemotherapy-induced anemia The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. <> 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. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Mean baseline Hgb levels Epogen is used in the dialysis area at CCF. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. 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).