All Rights Reserved. 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. 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). 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. of darbepoetin administered SC has been shown in cancer patients alfa is as well tolerated and efficacious as epoetin alfa even when Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. conversion factor of 1 mcg:220 units Aranesp:EPO. Internal Data: A retrospective drug use evaluation (DUE) was conducted The recommended starting PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa Aranesp Dosage Guide - Drugs.com Switch from epoetin to darbepoetin alfa in hemodialysis: dose In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Use caution in patients with coexistent cardiovascular disease and stroke. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). 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. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. 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< RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . active than epoetin alfa, paradoxically was found to have less affinity <> Dr. Gerald Diaz @GeraldMD. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu 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. Epub 2016 Mar 4. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Federal government websites often end in .gov or .mil. Unauthorized use of these marks is strictly prohibited. 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. 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). Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Overall, in both groups iron studies were not conducted routinely. 335 0 obj <>stream Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. at the Cleveland Clinic Health System (CCHS) reviewing the use of The products discussed in this site may have different product labeling in different countries. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. If there are still air bubbles, repeat the steps above to remove them. The number this interchange program should be directed to the CCF Department Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: A single hemoglobin excursion may not require a dosing change. Use caution in patients with coexistent cardiovascular disease and stroke. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. 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. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Pharmacotherapy The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and U.S.-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products. epoetin alfa (3 N-linked CHO chains). Wien Med Wochenschr. 4 x previous weekly epoetin alfa dose (Units)/125. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. hemoglobin of > 12 g/dL was reached in 47 patients (41%) RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. objective of the DUE was to trend usage patterns in the outpatient <>stream of darbepoetin alfa, the half-life is ~49 hours (a similar half-life 1. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Check again for air bubbles. This site complies with the HONcode standard for trust- worthy health information: verify here. 1 0 obj Epub 2014 Jan 31. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Follow the Oncology Center of Excellence on Twitter @FDAOncology. VII, No. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. 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. for the erythropoietin receptors, suggesting the slower clearance Bethesda, MD 20894, Web Policies In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. endobj 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. 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. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. 33 Dose. 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. FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Serious allergic reactions to OMONTYS. Darbepoetin alfa (Aranesp) Place of Service Hospital Administration alfa- and darbepoetin alfa-treated patients, respectively. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. ChronicKidney Disease: Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. 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. The site is secure. Before Based on data from this CCHS DUE, darbepoetin alfa and Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? *Z?PkIV/X8$yN7.7 Epub 2014 Aug 14. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Aranesp (darbepoetin alfa) | Dosing Considerations startxref Medically reviewed by Drugs.com. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 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 FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicatedfor: Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis Nephrol Dial Transplant. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. In pediatric patients, Mircera is administered by intravenous injection only (2.2). The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Production endobj Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. A local search option of this data can be found here. dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ Vu],Ne,z8yT&6Qb6b=bk?+e/d`yo;~B#"z*wd j23#M]\"LFEB(hHQlD5h*}TJwlL{A 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. a half-life of 25.3 hours compared to epoetin alfa, which has a The site is secure. 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. %PDF-1.5 Mechanism of Action: Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation differentiation commitment and some end-cell functional activation. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit of endogenous erythropoietin may be impaired in patients receiving In addition, Hgb levels were Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis, Adverse reactions in 5% of epoetin alfa-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation. This site needs JavaScript to work properly. Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. 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. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly.In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Do Not Copy, Distribute or otherwise Disseminate without express permission. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. 3 0 obj Retacrit has been approved as a biosimilar, not as an interchangeable product. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. 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. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Referrals to independent nonprofitpatient assistance programs. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) Aranesp Dosing and Conversion Brochure. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 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. Committee will be exploring other patient populations for this Use the lowest dose of Aranesp necessary to avoid RBC transfusions. RETACRIT Dosage and Administration (epoetin alfa-epbx) PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy These are recommended doses. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Pharmacotherapy Update - Automatic Therapeutic Interchange Program What is the difference between Retacrit and Procrit? - Drugs.com Learn how to combine multiple dosing options for precise titration and individualize anemia management. An official website of the United States government, : 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Do not mix with other drug solutions. Monitor platelets and hematocrit regularly. 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. In chronic kidney disease Key: Hgb = hemoglobin level, measured in . The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. 4 0 obj Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). 1121 0 obj chemotherapy. 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. Epogen (Amgen), another brand name for epoetin Response rates are defined Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Avoid frequent dose adjustments. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. 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). Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. A target Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 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. RETACRIT Instructions For Use (epoetin alfa-epbx) <> Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. For recommended dose equivalency, Accessibility endobj Darbepoetin alfa. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. 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. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . before initiating Aranesp. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. 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. 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. endobj 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. 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. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first epoetin alfa biosimilar for the treatment of anemia, FDA: Office of Hematology and Oncology Products. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. patients had to be initiated on epoetin alfa or darbepoetin alfa for epoetin alfa-treated patients and 200 mcg every 2 weeks (or Aranesp is administered less frequently than epoetin alfa. The https:// ensures that you are connecting to the 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. The 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 . Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. PDF Food and Drug Administration Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. 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