Epub 2004 Feb 19. Scroll left to view table. Background Anaemia is defined as a reduction of haemoglobin concentration, red . Vol. Use caution in patients with coexistent cardiovascular disease and stroke. Product Information and Dosing | Mircera Aranesp | European Medicines Agency Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Before prescribing RETACRIT single-dose vials to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including RETACRIT, Patients may require adjustments in their dialysis prescriptions after initiation of RETACRIT. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g.febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. Dose adjustment: If response is not satisfactory after a sufficient period of evaluation (8 weeks of 3 times/week and 4 weeks of once weekly therapy), the dose may be increased every 4 weeks (or longer) up to 300 units/kg 3 times/week, or when dosed weekly, increased all at once to 60,000 units weekly. in Hgb of 2 g/dL from baseline. The products discussed in this site may have different product labeling in different countries. Careers. About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Depending upon each patient's needs and response, dosage
FDA approves first epoetin alfa biosimilar for the treatment of anemia 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. 1. *Z?PkIV/X8$yN7.7 For recommended dose equivalency,
May 15, 2018. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Note: The manufacturer states that, until efficacy/toxicity parameters are established, the use of oprelvekin in pediatric patients (particularly those <12 years of age) should be restricted to use in controlled clinical trials. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
or 100 mcg SC once weekly. Update Index. Supplied Injection, powder for reconstitution: 5 mg, INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. See full prescribing information for RETACRIT. 1121 0 obj The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Learn how to combine multiple dosing options for precise titration and individualize anemia management. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. We comply with the HONcode standard for trustworthy health information. Evaluation of Iron Stores and Nutritional Factors. The recommended starting
of the molecule is a more important determinant of potency and receptor
Do not use Aranesp that has been shaken or frozen. gs+"!y]|"bA=!ZuP
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EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? 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). Hgb level. Retacrit has been approved as a biosimilar, not as an interchangeable product. group. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. Protect vials and prefilled syringes from light. Last updated on Jan 20, 2023. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. . Federal government websites often end in .gov or .mil. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). 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. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. patients and 55 darbepoetin alfa patients. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. 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. Internal Data: A retrospective drug use evaluation (DUE) was conducted
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. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN
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R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. Committee will be exploring other patient populations for this
The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. 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 . <>
Generic name: DARBEPOETIN ALFA 10ug in 0.4mL The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. epoetin alfa produce similar Hgb levels in patients with CIA. 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. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin
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. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. _____ (if . The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. VII, No. 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). %PDF-1.5
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 . Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. official website and that any information you provide is encrypted Study of Transplant Related Anemia Treated With Aranesp (STRATA alfa and 200 mcg every 2 weeks for darbepoetin alfa. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Select one or more newsletters to continue. doses. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. Production
At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee
a half-life of 25.3 hours compared to epoetin alfa, which has a
PDF Food and Drug Administration The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. . To report an adverse event, please call 1-800-438-1985. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Mircera Dosage Guide - Drugs.com endstream 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. overall. 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. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. epoetin alfa and darbepoetin alfa for the management of CIA. In chronic kidney disease
In addition, at this time, this interchange program does not affect
What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Pharmacotherapy
%%EOF 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. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. David McAuley, Pharm.D. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. government site. 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. of darbepoetin administered SC has been shown in cancer patients
When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 4 x previous weekly epoetin alfa dose (Units)/125. In addition, Hgb levels were
The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned %
All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. Pussell BA, Walker R; Australian Renal Anaemia Group. Increase dose by 50-100 units/kg 3 times/week if response is not satisfactory in terms of reducing transfusion requirements or increasing hemoglobin after 8 weeks of therapy. (PDF) Conversion from epoetin beta to darbepoetin: What is the Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Results: 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. most common dosing regimens are 40,000 units weekly for epoetin
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. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Accessibility Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. %PDF-1.6
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National Library of Medicine 1. 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. Adjust dose as follows to achieve and maintain a target hemoglobin: Inadequate response: Hemoglobin increases <1 g/dL after 6 weeks of therapy: Increase dose to 4.5 mcg/kg. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Copyright 1993-2021 -m]|;VB
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MT"_jlhV&AV7^Hiud:.B.4=>^ 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). Avoid frequent dose adjustments. Aranesp (darbepoetin alfa) | Dosing Considerations similar over the course of therapy for both groups. 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. However, this may result in the over treatment of uraemic anaemia. Nephrol Dial Transplant. Decreases in dose can occur more frequently. MeSH 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. Can J Kidney Health Dis. The site is secure. Ann Pharmacother. Call 1-888-4ASSIST to find out more. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions.