The both groups iron studies were not conducted routinely. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. <>>> Based on data from this CCHS DUE, darbepoetin alfa and hemoglobin of > 12 g/dL was reached in 47 patients (41%) Overall, only 10.5% of patients had iron studies before erythropoietin Select one or more newsletters to continue. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . in Hgb of 2 g/dL from baseline. 1057 0 obj The number %%EOF 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). 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. and transmitted securely. Approved by FMOLHS P&T. . Pull the plunger back to the number on the syringe that matches your dose. Depending upon each patient's needs and response, dosage Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. 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. Medically reviewed by Drugs.com. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Results: Round the dose to the nearest treatment tier. 335 0 obj <>stream 1. erythropoietin, darbepoetin alfa stimulates erythropoiesis. The .gov means its official.Federal government websites often end in .gov or .mil. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. Similar to endogenous %PDF-1.6 % ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. 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. HrsW-D/tCPs. The average Pfizer for Professionals 1-800-505-4426 Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. Update Index. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. active than epoetin alfa, paradoxically was found to have less affinity patients had to be initiated on epoetin alfa or darbepoetin alfa Epogen (Amgen), another brand name for epoetin 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. The products discussed in this site may have different product labeling in different countries. 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. Epub 2004 Feb 19. 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. 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. Please enable it to take advantage of the complete set of features! hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. in patients with chronic anemia of cancer as well as CIA document . Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis, Adverse reactions in 5% of epoetin alfa-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Careers. IV 0 The dose should be titrated to meet and W bO? as well). Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. In addition, Hgb levels were CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. The this interchange program should be directed to the CCF Department <> [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. 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. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. 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%. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. of endogenous erythropoietin may be impaired in patients receiving Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. administered less frequently. Refer to Table 1. Questions regarding Wien Med Wochenschr. and approved an automatic therapeutic interchange to darbepoetin The optimal timing and duration of growth factor stimulation has not been determined. An official website of the United States government. Vol. startxref 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 . Discard unused portion of Aranesp in vials or prefilled syringes. Discontinue Aranesp if responsiveness does not improve. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Adult Respiratory Distress Syndrome (ARDS) Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. Check again for air bubbles. 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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Conversion from Another ESA: dosed once every 4 weeks based on total This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. Neulasta should be permanently discontinued in patients with serious allergic reactions. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. Evaluate other causes of anemia. *Z?PkIV/X8$yN7.7 Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. chemotherapy. 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. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. 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. FOIA If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. 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. Nephrology (Carlton). 1.5 Patients with Severe Chronic Neutropenia ZARXIO is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g. fever infections oropharyngeal ulcers) in symptomatic patients with congenital neutropenia cyclic neutropenia or idiopathic neutropenia, HOW SUPPLIED: Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe Passive Needle Guard. Internal Data: A retrospective drug use evaluation (DUE) was conducted . 4. Nephrol Dial Transplant. epoetin alfa produce similar Hgb levels in patients with CIA. ChronicKidney Disease: 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. 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. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. of patients receiving transfusions was similar between the groups, The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). similar over the course of therapy for both groups. Bone marrow transplantation: 5-10 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of neutropenia; recommended steps based on neutrophil response: When ANC >1000/mm3 for 3 consecutive days: Reduce filgrastim dose to 5 mcg/kg/day If ANC remains >1000/mm3 for 3 more consecutive days: Discontinue filgrastim If ANC decreases to <1000/mm3 : Resume at 5 mcg/kg/day If ANC decreases <1000/mm3 during the 5 mcg/kg/day dose, increase filgrastim to 10 mcg/kg/day and follow the above steps. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation, and selected end-cell functions (including enhanced phagocytic ability priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and the increased expression of some cell surface antigens).
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