335 0 obj
<>stream
Overall, only 10.5% of patients had iron studies before erythropoietin
Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. Before sharing sensitive information, make sure you're on a federal government site. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Monitor platelets and hematocrit regularly. 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. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Epub 2014 Aug 14. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 4. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. 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. at the Cleveland Clinic Health System (CCHS) reviewing the use of
of the molecule is a more important determinant of potency and receptor
sharing sensitive information, make sure youre on a federal Do not dilute. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6
r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Nephrology (Carlton). Background: %%EOF In CKD, for subcutaneous (SC) administration
After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL, 300 Units/kg 3 times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. Please enable it to take advantage of the complete set of features! The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. epoetin alfa and darbepoetin alfa for the management of CIA. <>
7/2021: added Epogen (nonformulary). Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. These are recommended doses. 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. CHO chains) has a 3-fold increase in half-life when compared to
Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. 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. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Hgb level. Check again for air bubbles. Evaluation of Iron Stores and Nutritional Factors. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. The recommended starting
(CIA) for both outpatients and inpatients. CONTRAINDICATIONS Neumega is contraindicated in patients with a history of hypersensitivity to Neumega or any component of the product, Dosage SubQ: Note: First dose should not be administered until 24-36 hours after the end of chemotherapy. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. 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. 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). When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Aranesp is administered less frequently than epoetin alfa. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated
A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. 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 . 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. 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). Epub 2014 Jan 31. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin
Based on data from this CCHS DUE, darbepoetin alfa and
Studies of erythropoietin therapy
*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. Copyright 1993-2021 Background Anaemia is defined as a reduction of haemoglobin concentration, red . 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. The most frequent dosing regimens were 40,000 units weekly
2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. Although these images are curated, as they are sourced from the community, there is no way to guarantee a consistent standard of accuracy and quality across the library of images. 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. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. 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). 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee
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 . 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. 4 x previous weekly epoetin alfa dose (Units)/125. alfa- and darbepoetin alfa-treated patients, respectively. 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. ChronicKidney Disease: endobj
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 . Protect vials and prefilled syringes from light. _
p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. a half-life of 25.3 hours compared to epoetin alfa, which has a
deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin
similar over the course of therapy for both groups. most common dosing regimens are 40,000 units weekly for epoetin
RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. and transmitted securely. alfa for chronic anemia of cancer and chemotherapy-induced anemia
VII, No. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Do not re-enter vial. <>
!SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X
T]{oF`S}+c|yt}
}
;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL`
z0
DY%--V! Epogen (Amgen), another brand name for epoetin
e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. In patients receiving treatment for cancer and whose anemia is not due to CKD. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r
SN:]AW&g{auwi(D)Si'(EK 9P$a8d_R/au&tIk=[A'"Uh
5E~"{dC4dMs/*e?&Io}a\d05zVJ)~OL:MK'tiM>)r4zoBp`Vju`'78f4*q-PFa_,R2(r\?ASM^B6DT&s+IfUSqS6H5l~b)lMx:'j_sT[.q"ju g/8f5>tWw]}vAQNK0:
st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c May 15, 2018. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). Discontinue Aranesp if responsiveness does not improve. 2. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life
FOIA [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. Aranesp Dosing and Conversion Brochure. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. arena for dosing, dosing interval, hemoglobin levels, number of
Safety and Efficacy: Currently available data indicate that darbepoetin
Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. epoetin alfa and darbepoetin alfa, have been shown to decrease the
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. %PDF-1.5
Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks and iron stores are adequate: Increase by ~25% of the previous dose; increases should not be made more frequently than once monthly. Last updated on Jan 20, 2023. 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. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. 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). Chronic Kidney Disease: 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. 3 0 obj
Vol. . hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. HrsW-D/tCPs. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . 2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. These adverse reactions included myocardial infarction and stroke, In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. In addition, at this time, this interchange program does not affect
Do not shake. On May 15, 2018, the Food and Drug Administration approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG
M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< 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
overall. %PDF-1.6
%
2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Evaluate the iron status in all patients before and during treatment. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. In chronic kidney disease
Wien Med Wochenschr. Round the dose to the nearest treatment tier. 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:
Independent Anglican Church,
Articles A