aranesp to retacrit conversionaranesp to retacrit conversion
If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. Questions regarding Epoetin alfa. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 IV route is recommended for patients on hemodialysis, For adult patients with CKD not on dialysis, The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC, The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly IV or SC, Recommended dosing for patients with HIV treated with zidovudine, The recommended starting dose in adults is 100 Units/kg as an IV or SC injection 3 times per week, If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid red blood cell (RBC) transfusions or 300 Units/kg, Recommended starting dose for adults and children undergoing cancer chemotherapy*, 150 Units/kg SC 3 times per week until completion of a chemotherapy course, or, 40,000 Units SC weekly until completion of a chemotherapy course, 600 Units/kg IV weekly until completion of a chemotherapy course. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Internal Data: A retrospective drug use evaluation (DUE) was conducted endobj This site is intended only for U.S. healthcare professionals. sharing sensitive information, make sure youre on a federal Switch from epoetin to darbepoetin alfa in hemodialysis: dose Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. Depending upon each patient's needs and response, dosage adjustments may be required. The majority of reported events occurred upon initial exposure. Keep the tip of the needle in the RETACRIT liquid. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Update Index. PMC 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). . Avoid frequent dose adjustments. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. adjustments may be required. RETACRIT is contraindicated in patients with: RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM, INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER, LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT, RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE, ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE, ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER, ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION, Recommended dosing for adults and children with chronic kidney disease (CKD), The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously (IV) or subcutaneously (SC). Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Available for Android and iOS devices. Epogen (Amgen), another brand name for epoetin Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). Do not increase the dose more frequently than once every 4 weeks. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). Aranesp Dosing and Conversion Brochure. Based on data from this CCHS DUE, darbepoetin alfa and . Pharmacotherapy %PDF-1.6 % Bethesda, MD 20894, Web Policies The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. _____ (if . The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned alfa is as well tolerated and efficacious as epoetin alfa even when 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. The site is secure. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. 0 x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y PDF Erythropoietin Stimulating Agents: Darbepoetin alfa (Aranesp), Epoetin The .gov means its official. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. RETACRIT Instructions For Use (epoetin alfa-epbx) Drug class: Recombinant human erythropoietins. of endogenous erythropoietin may be impaired in patients receiving RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . 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. 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. Conclusion: If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Background Anaemia is defined as a reduction of haemoglobin concentration, red . 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. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . interchange, such as patients with chronic renal failure (CRF). eCollection 2017. 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. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. This site is intended for U.S. healthcare professionals. The https:// ensures that you are connecting to the <> Table 1. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. MeSH contracts, darbepoetin alfa is less expensive than epoetin alfa. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. All Rights Reserved. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 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 . Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Maintain the route of administration (intravenous or subcutaneous injection). dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week 1. alfa. Existing patients on IV EPO, change to subcutaneous EPO using the . 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. In order to be included in the DUE, every-other-week) for darbepoetin alfa-treated patients. 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. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) In chronic kidney disease zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed in patients with chronic anemia of cancer as well as CIA document 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. 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. 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: 1.5 Patients with Severe Chronic Neutropenia ZARXIO is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g. fever infections oropharyngeal ulcers) in symptomatic patients with congenital neutropenia cyclic neutropenia or idiopathic neutropenia, HOW SUPPLIED: Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard. erythropoietin, darbepoetin alfa stimulates erythropoiesis. 2. Medically reviewed by Drugs.com. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. <>stream half-life of 8.5 hours. Disclaimer. Bookshelf Slowly push the plunger up to force the air bubbles out of the syringe. W bO? REASON FOR . Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Use caution in patients with coexistent cardiovascular disease and stroke. endobj Unable to load your collection due to an error, Unable to load your delegates due to an error. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. (PDF) Conversion from epoetin beta to darbepoetin: What is the The dose should be titrated to meet and Based on the patient's response, darbepoetin Discard unused portion of Aranesp in vials or prefilled syringes. Would you like email updates of new search results? Before Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. In addition, at this time, this interchange program does not affect 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. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Conversion of IV to SC EPO: a. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub In addition, Hgb levels were The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. David McAuley, Pharm.D. of darbepoetin administered SC has been shown in cancer patients Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. for at least 3 weeks between July 2002 and July 2003. In the near future, the Pharmacy and Therapeutics What is the practical conversion dose when changing from epoetin alfa duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin While a discounted alternative to Epogen and Procrit is welcome, there is a catch. %PDF-1.5 Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. 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)]. These adverse reactions included myocardial infarction and stroke, In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). administered less frequently. 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)]. Ann Pharmacother. Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. therapy. 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. Select one or more newsletters to continue. 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)]. The average HrsW-D/tCPs. 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). PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. The recommended starting ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. July/August 2004, Return to 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. 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. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X T]{oF`S}+c|yt} } ;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL` z0 DY%--V! 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. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Aranesp is administered less frequently than epoetin alfa. Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria . 33 Dose. Nephrology (Carlton). Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. 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 . 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated and transmitted securely. 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 patients and 55 darbepoetin alfa patients. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. 1022 0 obj Dr. Gerald Diaz @GeraldMD. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. transfusions, and iron studies. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. number of patients receiving transfusions, to increase hemoglobin 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. Approved by FMOLHS P&T. . k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Evaluate the iron status in all patients before and during treatment. 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. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. <> The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. epoetin alfa and darbepoetin alfa, have been shown to decrease the in two ways: 1) Hgb levels > 12 g/dL or 2) an increase If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. Aranesp Dosage Guide - Drugs.com 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 . Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 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. 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)]. 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. May 15, 2018. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). JKn&,&LzN Switching Between Epoetins: A Practice in Support of Biosimilar Use Wien Med Wochenschr. The implementation date for the interchange program is October 11, 2004. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy.
Lee County, Florida Court Records,
Black Spot On Gums Photos,
Elise Stefanik Parents,
Katie Thompson Wedding Date,
Articles A
