However, this may result in the over treatment of uraemic anaemia. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Wien Med Wochenschr. Serious allergic reactions to OMONTYS. <> 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. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. 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. 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. 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%. scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Adjust dose as follows to achieve and maintain a target hemoglobin: Inadequate response: Hemoglobin increases <1 g/dL after 6 weeks of therapy: Increase dose to 4.5 mcg/kg. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Dosage form: injection, solution Evaluate the iron status in all patients before and during treatment. Product Information and Dosing | Mircera affinity has no or little clinical relevance. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . Epoetin alfa. JKn&,&LzN Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Key: Hgb = hemoglobin level, measured in . Call 1-888-4ASSIST to find out more. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. <>stream Conversion of IV to SC EPO: a. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned (PDF) Conversion from epoetin beta to darbepoetin: What is the Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Maintain the route of administration (intravenous or subcutaneous injection). : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh of darbepoetin administered SC has been shown in cancer patients Avoid frequent dose adjustments. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. This site complies with the HONcode standard for trust- worthy health information: verify here. 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. Please enable it to take advantage of the complete set of features! Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. and approved an automatic therapeutic interchange to darbepoetin 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 half-life of 8.5 hours. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin 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. Switching Between Epoetins: A Practice in Support of Biosimilar Use Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. 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. Pharmacotherapy Update - Automatic Therapeutic Interchange Program Use caution in patients with coexistent cardiovascular disease and stroke. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). 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. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. PDF Food and Drug Administration All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. 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 . of the molecule is a more important determinant of potency and receptor Before sharing sensitive information, make sure you're on a federal government site. epoetin alfa and darbepoetin alfa for the management of CIA. 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. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. 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. %PDF-1.5 The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. 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. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Retacrit has been approved as a biosimilar, not as an interchangeable product. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* maintain desired hemoglobin (Hgb) levels. Do not increase the dose more frequently than once every 4 weeks. for the erythropoietin receptors, suggesting the slower clearance 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. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. %%EOF 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)]. 7. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Vol. The .gov means its official. May 15, 2018. Based on data from this CCHS DUE, darbepoetin alfa and The most frequent dosing regimens were 40,000 units weekly IV Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. July/August 2004, Return to Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. RETACRIT Instructions For Use (epoetin alfa-epbx) FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx 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 . All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. Depending upon each patient's needs and response, dosage Discontinue Aranesp if responsiveness does not improve. All Rights Reserved. RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) In addition, Hgb levels were 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). Neulasta should not be used for PBPC mobilization. arena for dosing, dosing interval, hemoglobin levels, number of endobj Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. FDA approves first epoetin alfa biosimilar for the treatment of anemia 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)]. Aranesp (darbepoetin alfa) | Dosing Considerations This site needs JavaScript to work properly. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 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. An official website of the United States government. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. Refer to Aranesp package insert for pediatric dosing conversion. W bO? and 24 patients in the darbepoetin alfa group reached the targeted For recommended dose equivalency, The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Do not shake. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. However, this may result in the over treatment of uraemic anaemia. 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). 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. Existing patients on IV EPO, change to subcutaneous EPO using the . Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Background Anaemia is defined as a reduction of haemoglobin concentration, red . Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. A total of startxref Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). adjustments may be required. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. 8600 Rockville Pike Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). The recommended starting 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. or 100 mcg SC once weekly. Before sharing sensitive information, make sure you're on a federal government site. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) . 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy 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. 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. We comply with the HONcode standard for trustworthy health information. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. sharing sensitive information, make sure youre on a federal Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. Aranesp | European Medicines Agency The average 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. 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. 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. M(aOf}c^gw+&=s=O{+h5ACmVA;8*=vSO`8dmD}a"'3L DMr7GwG 3\\q'z .MreQlX`DWxxxnU@!TUrTng_wAMc`0N[P Si)i+j(1A%@xaB&Zx03\'O.h` &!T6. 0*ET*LQjH!z!6G OsI`~ patients and 55 darbepoetin alfa patients. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Based on the patient's response, darbepoetin of darbepoetin alfa, the half-life is ~49 hours (a similar half-life 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. objective of the DUE was to trend usage patterns in the outpatient Committee will be exploring other patient populations for this Conclusion: Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. 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). % The implementation date for the interchange program is October 11, 2004. hemoglobin of > 12 g/dL was reached in 47 patients (41%) Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. The optimal timing and duration of growth factor stimulation has not been determined. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Accessibility alfa is as well tolerated and efficacious as epoetin alfa even when 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. If patient does not respond, a response to higher doses is unlikely. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) RETACRIT safely and effectively. 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. The For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Darbepoetin alfa (Aranesp) Place of Service Hospital Administration Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. If there are still air bubbles, repeat the steps above to remove them. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. erythropoietin, darbepoetin alfa stimulates erythropoiesis. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 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. of endogenous erythropoietin may be impaired in patients receiving The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin 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 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. 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. contracts, darbepoetin alfa is less expensive than epoetin alfa. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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. Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. 2. See full prescribing information for RETACRIT. administered less frequently. Internal Data: A retrospective drug use evaluation (DUE) was conducted In chronic kidney disease lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB 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. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. eCollection 2017. Disclaimer. MeSH Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Update Index. 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). <> 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. 1. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.
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