Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. alfa is as well tolerated and efficacious as epoetin alfa even when
GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. of darbepoetin administered SC has been shown in cancer patients
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. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]?
Pharmacotherapy Update - Automatic Therapeutic Interchange Program maintain desired hemoglobin (Hgb) levels. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy).
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< Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. 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. Retacrit has been approved as a biosimilar, not as an interchangeable product. 7/2021: added Epogen (nonformulary). Slowly push the plunger up to force the air bubbles out of the syringe.
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. 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). After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. A total of
The recommended starting
Copyright 1993-2021 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.
Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed epoetin alfa and darbepoetin alfa, have been shown to decrease the
Background Anaemia is defined as a reduction of haemoglobin concentration, red . 335 0 obj
<>stream
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 . Monitor platelets and hematocrit regularly. 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: Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Accessibility a half-life of 25.3 hours compared to epoetin alfa, which has a
Evaluate the iron status in all patients before and during treatment. 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. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. This site is intended only for U.S. healthcare professionals. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u 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. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE .
PDF Highlights of Prescribing Information ----------------------- Dosage 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. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL National Library of Medicine RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. Please review the latest applicable package insert for additional information and possible updates. -m]|;VB
&mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$
8\n^l|w,|1K
sewEVzhc
MT"_jlhV&AV7^Hiud:.B.4=>^ _
p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) 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). patients had to be initiated on epoetin alfa or darbepoetin alfa
2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) in Hgb of 2 g/dL from baseline. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Nephrol Dial Transplant. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . This site is intended for U.S. healthcare professionals. 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. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. startxref therapy.
Aranesp (darbepoetin alfa) | Dosing Considerations Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. *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. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. 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. 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. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? 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. Vol. Decreases in dose can occur more frequently. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. of Pharmacy Drug Information Center (216-444-6456, option #1). <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
as well). Conversion from Another ESA: dosed once every 4 weeks based on total active than epoetin alfa, paradoxically was found to have less affinity
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.
(PDF) Conversion from epoetin beta to darbepoetin: What is the Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. hemoglobin of > 12 g/dL was reached in 47 patients (41%)
Do not dilute Aranesp and do not administer in conjunction with other drug solutions. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Response rates are defined
Reduce or withhold RETACRIT if blood pressure becomes difficult to control. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. HHS Vulnerability Disclosure, Help The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). endstream 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. 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). 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. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 1022 0 obj Overall, in
In pediatric patients, Mircera is administered by intravenous injection only (2.2). <> The safety and effectiveness of Neumega have not been established in pediatric patients. Advise patients to contact their healthcare practitioner for new-onset seizures, premonitory symptoms or change in seizure frequency, For lack or loss of hemoglobin response to RETACRIT, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding). Do not increase the dose more frequently than once every 4 weeks. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. Overall, only 10.5% of patients had iron studies before erythropoietin
The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU).
PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb erythropoietin, darbepoetin alfa stimulates erythropoiesis.