aranesp to retacrit conversion aranesp to retacrit conversion

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. Conversion from Another ESA: dosed once every 4 weeks based on total 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. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. 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. Depending upon each patient's needs and response, dosage adjustments may be required. <>stream most common dosing regimens are 40,000 units weekly for epoetin 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. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. government site. An official website of the United States government, : Discard unused portion of Aranesp in vials or prefilled syringes. Do not re-enter vial. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Key: Hgb = hemoglobin level, measured in . Disclaimer. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Before sharing sensitive information, make sure you're on a federal government site. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. official website and that any information you provide is encrypted CHO chains) has a 3-fold increase in half-life when compared to Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. epoetin alfa and darbepoetin alfa, have been shown to decrease the A total of 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. 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. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. 1022 0 obj of endogenous erythropoietin may be impaired in patients receiving 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). 1. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. However, this may result in the over treatment of uraemic anaemia. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL Before sharing sensitive information, make sure you're on a federal government site. Nephrol Dial Transplant. This site is intended only for U.S. healthcare professionals. 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. 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. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or Reduce or withhold RETACRIT if blood pressure becomes difficult to control. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. 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. Do not dilute. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life 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 average Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. Pharmacotherapy The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. Similar to endogenous MeSH The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. <> In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. <>>> Overall, in both groups iron studies were not conducted routinely. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. Epub 2014 Aug 14. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. alfa. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. 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). Ann Pharmacother. Patients on Cancer Chemotherapy 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. 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. Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. 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). 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. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Aranesp Dosing and Conversion Brochure. Do Not Copy, Distribute or otherwise Disseminate without express permission. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. erythropoietin, darbepoetin alfa stimulates erythropoiesis. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. . Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Epogen (Amgen), another brand name for epoetin %PDF-1.5 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 . Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. 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)]. 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 Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. endstream endobj 336 0 obj <>stream Use the lowest dose of Aranesp necessary to avoid RBC transfusions. This site complies with the HONcode standard for trust- worthy health information: verify here. HHS Vulnerability Disclosure, Help 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 . In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. Federal government websites often end in .gov or .mil. 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. Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. levels, and to improve quality of life. 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 . Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC 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 . 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. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. doses. Pussell BA, Walker R; Australian Renal Anaemia Group. Call 1-888-4ASSIST to find out more. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. <> in Hgb of 2 g/dL from baseline. Vol. 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. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. before initiating Aranesp. Conclusion: We comply with the HONcode standard for trustworthy health information. 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. 33 Dose. as well). 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. Safety and Efficacy: Currently available data indicate that darbepoetin \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Overall, only 10.5% of patients had iron studies before erythropoietin scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of . Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Do not shake. The .gov means its official.Federal government websites often end in .gov or .mil. The .gov means its official. Contributed by. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. of patients receiving transfusions was similar between the groups, epoetin alfa and darbepoetin alfa for the management of CIA. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Approved by FMOLHS P&T. . Neulasta should not be used for PBPC mobilization. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Initial U.S. Approval: 2018 . G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation and selected end-cell functional activation (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody dependent killing, and the increased expression of some functions associated with cell surface antigens). Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. IV adjustments may be required. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. Overall, in See full prescribing information for RETACRIT. of the molecule is a more important determinant of potency and receptor At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee While a discounted alternative to Epogen and Procrit is welcome, there is a catch. 1121 0 obj deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. objective of the DUE was to trend usage patterns in the outpatient 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 ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. 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). EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 8600 Rockville Pike 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. 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 OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. The https:// ensures that you are connecting to the Mean baseline Hgb levels The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 150 units/kg SC 3 times/week or 40,000 units once weekly. Response rates are defined e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. see Tables A and B (below). Clipboard, Search History, and several other advanced features are temporarily unavailable. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Referrals to independent nonprofitpatient assistance programs. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u 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. 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. Committee will be exploring other patient populations for this The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. in patients with chronic anemia of cancer as well as CIA document 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 the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Patients were then switched to fortnightly darbepoetin alfa dosing treatments; the existing weekly dose being doubled and Hb levels fell from 125 to 110 g/L (P < 0.0001), despite an increase in the mean dose from 44.9 to 47.5 microg/week (P = 0.02). Epub 2014 Jan 31. The majority of reported events occurred upon initial exposure. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). 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. To report an adverse event, please call 1-800-438-1985. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. A single hemoglobin excursion may not require a dosing change. 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. both groups iron studies were not conducted routinely. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. 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. alfa is as well tolerated and efficacious as epoetin alfa even when A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. 7/2021: added Epogen (nonformulary). The products discussed in this site may have different product labeling in different countries. Epoetin alfa. 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.