hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Evaluate other causes of anemia. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; 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%. for the erythropoietin receptors, suggesting the slower clearance erythropoietin, darbepoetin alfa stimulates erythropoiesis. FOIA in Hgb of 2 g/dL from baseline. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Studies of erythropoietin therapy Based on the patient's response, darbepoetin 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. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. Discard unused portion of Aranesp in vials or prefilled syringes. In addition, Hgb levels were RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Based on data from this CCHS DUE, darbepoetin alfa and Check again for air bubbles. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. In the near future, the Pharmacy and Therapeutics What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* 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. Approved by FMOLHS P&T. . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. 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). The .gov means its official.Federal government websites often end in .gov or .mil. A single hemoglobin excursion may not require a dosing change. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 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). Can J Kidney Health Dis. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. The site is secure. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u a half-life of 25.3 hours compared to epoetin alfa, which has a overall. Would you like email updates of new search results? Unauthorized use of these marks is strictly prohibited. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . As a substitute for RBC transfusions in patients who require immediate correction of anemia. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. More specifically, 23 patients in the epoetin alfa group The site is secure. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Initial U.S. Approval: 2018 . Keep the tip of the needle in the RETACRIT liquid. Do not dilute. active than epoetin alfa, paradoxically was found to have less affinity No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Darbepoetin alfa, although several fold more biologically Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. Overall, only 10.5% of patients had iron studies before erythropoietin Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). response rates ranging from ~60% to 85%. Aranesp Dosing and Conversion Brochure. 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. 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)]. <> The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. The FDAs approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit. 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. A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. 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. chemotherapy. Follow the Oncology Center of Excellence on Twitter @FDAOncology. as well). 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. 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. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves Retacrit as a biosimilar to Epogen/Procrit, Drug Information Soundcast in Clinical Oncology. The average Avoid frequent dose adjustments. 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. Please enable it to take advantage of the complete set of features! Depending upon each patient's needs and response, dosage official website and that any information you provide is encrypted Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. Medically reviewed by Drugs.com. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. 3 0 obj 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. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. W bO? Wien Med Wochenschr. 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 . Pharmacotherapy levels, and to improve quality of life. Careers. at the Cleveland Clinic Health System (CCHS) reviewing the use of Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Evaluation of Iron Stores and Nutritional Factors. The majority of reported events occurred upon initial exposure. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . 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. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. 150 units/kg SC 3 times/week or 40,000 units once weekly. Scroll left to view table. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). %PDF-1.6 % 4 x previous weekly epoetin alfa dose (Units)/125. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. 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. 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. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. 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. The dose should be titrated to meet and The site is secure. Slowly push the plunger up to force the air bubbles out of the syringe. AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. Dr. Gerald Diaz @GeraldMD. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefits. Aranesp is administered less frequently than epoetin alfa. 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. 4. 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. 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. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. of Pharmacy Drug Information Center (216-444-6456, option #1). 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 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. 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)]. Epub 2009 Aug 4. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. alfa is as well tolerated and efficacious as epoetin alfa even when Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. 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< (CIA) for both outpatients and inpatients. Disclaimer. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Available for Android and iOS devices. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of Aranesp or whether the patient would benefit from a different Aranesp presentation. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1). 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)]. transfusions, and iron studies. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase 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. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. <> 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 . Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit Refer to Table 1. Update Index. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Woodland AL, Murphy SW, Curtis BM, Barrett BJ. National Library of Medicine Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). The safety and effectiveness of Neumega have not been established in pediatric patients. Key: Hgb = hemoglobin level, measured in . for at least 3 weeks between July 2002 and July 2003. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Evaluate the iron status in all patients before and during treatment. _____ (if . Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. 4. Maintain the route of administration (intravenous or subcutaneous injection). Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Both drugs are costly: January 2003 prices posted by Medicare put reimbursement rates at $12.69 per 1000 units of Procrit (translating to about $534.32 for the Average Wholesale Price [AWP] for a once-a-week dose of 40,000 units) and $23.69 per 5 micrograms of Aranesp (about $994.98 for the AWP for a 3 mcg/kg dose every other week). 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 . OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. Round the dose to the nearest treatment tier. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Monitor platelets and hematocrit regularly. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. 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. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 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. adjustments may be required. The most frequent dosing regimens were 40,000 units weekly Copyright 1993-2021 administered less frequently. hemoglobin of > 12 g/dL was reached in 47 patients (41%) Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency, For lack or loss of hemoglobin response to RETACRIT, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding). Response rates are defined alfa (Aranesp; Amgen) to be therapeutic equivalent products of the molecule is a more important determinant of potency and receptor epoetin alfa produce similar Hgb levels in patients with CIA. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. epoetin alfa and darbepoetin alfa for the management of CIA. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and 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. alfa-treated patients, respectively. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO.
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