Safety and Efficacy: Currently available data indicate that darbepoetin
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). Based on market share
0 Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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. 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.
Study of Transplant Related Anemia Treated With Aranesp (STRATA ChronicKidney Disease: The most frequent dosing regimens were 40,000 units weekly
Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. of darbepoetin administered SC has been shown in cancer patients
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p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) 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 . 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. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Please enable it to take advantage of the complete set of features! Before Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination.
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in patients with chronic anemia of cancer as well as CIA document
EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . 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. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin
Nephrol Dial Transplant.
FDA approves first epoetin alfa biosimilar for the treatment of anemia a half-life of 25.3 hours compared to epoetin alfa, which has a
Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) Drug class: recombinant human erythropoietins, Aranesp (Darbepoetin Alfa Prefilled Syringes), Anemia Associated with Chronic Renal Failure, If hemoglobin exceeds a level needed to avoid RBC transfusion, If hemoglobin increases by less than 1 g/dL. 1. Refer to Table 1. of patients receiving transfusions was similar between the groups,
Aranesp (darbepoetin alfa) | Dosing Considerations This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance Available for Android and iOS devices. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. 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. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u gs+"!y]|"bA=!ZuP
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EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. epoetin alfa and darbepoetin alfa for the management of CIA. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. 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`~ In pediatric patients, Mircera is administered by intravenous injection only (2.2).
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. 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. 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. WARNINGS: ESAs INCREASE THE 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. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Overall, only 10.5% of patients had iron studies before erythropoietin
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. transfusions, and iron studies. Aranesp Dosing and Conversion Brochure. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
Darbepoetin alfa.
Switch from epoetin to darbepoetin alfa in hemodialysis: dose Refer to Aranesp package insert for pediatric dosing conversion. This site is intended for U.S. healthcare professionals.
Do Not Copy, Distribute or otherwise Disseminate without express permission. If patient does not respond, a response to higher doses is unlikely. Epub 2014 Jan 31. Conversion of IV to SC EPO: a. The average
Key: Hgb = hemoglobin level, measured in .
Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed and transmitted securely. A single hemoglobin excursion may not require a dosing change.
FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA 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. 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. Darbepoetin alfa, although several fold more biologically
Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 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)]. Careers. In cancer patients, erythropoietic agents, including
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 . Overall, in
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.
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). %
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REASON FOR . Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Do not re-enter vial. in Hgb of 2 g/dL from baseline. of Pharmacy Drug Information Center (216-444-6456, option #1). 4y\@:hT4\j
EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. for the erythropoietin receptors, suggesting the slower clearance
PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa The .gov means its official.Federal government websites often end in .gov or .mil. Epoetin alfa. Accessibility RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X
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DY%--V! To report an adverse event, please call 1-800-438-1985. erythropoietin, darbepoetin alfa stimulates erythropoiesis. Discontinue Aranesp if responsiveness does not improve. Please review the latest applicable package insert for additional information and possible updates. Martnez Castelao A, Reyes A, Valds F, Otero A, Lpez de Novales E, Pallard L, Tabernero JM, Hernndez Jaras J, Llads F. Brunkhorst R, Bommer J, Braun J, Haag-Weber M, Gill C, Wagner J, Wagener T; German Aranesp Study Group. [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. The site is secure. Darbepoetin alfa (5 N-linked
Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. interchange, such as patients with chronic renal failure (CRF). Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. endobj
Can J Kidney Health Dis. 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. doses. When therapy with RETACRIT is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In controlled clinical trials of patients with chronic kidney disease (CKD) comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), epoetin alfa increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups, 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 benefit. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. The intravenous route is recommended for patients on hemodialysis. In order to be included in the DUE,
Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. every-other-week) for darbepoetin alfa-treated patients. group. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 1022 0 obj JKn&,&LzN Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. alfa-treated patients, respectively. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. active than epoetin alfa, paradoxically was found to have less affinity
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. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? IV
1121 0 obj RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. 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. 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy ZARXIO is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)]. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity.