This site needs JavaScript to work properly. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. 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. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. Do not shake. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . 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). for epoetin alfa-treated patients and 200 mcg every 2 weeks (or Background: patients had to be initiated on epoetin alfa or darbepoetin alfa Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. The most frequent dosing regimens were 40,000 units weekly General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. Referrals to independent nonprofitpatient assistance programs. Before sharing sensitive information, make sure you're on a federal government site. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. This site is intended only for U.S. healthcare professionals. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN $l-FRW+>U0pPhRc/N R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" Unable to load your collection due to an error, Unable to load your delegates due to an error. The number For recommended dose equivalency, Monitor platelets and hematocrit regularly. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Pharmacotherapy Update - Automatic Therapeutic Interchange Program Accessibility Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. Before prescribing RETACRIT single-dose vials to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including RETACRIT, Patients may require adjustments in their dialysis prescriptions after initiation of RETACRIT. Depending upon each patient's needs and response, dosage adjustments may be required. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 1. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y 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. The site is secure. 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 . 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). No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). Darbepoetin alfa (5 N-linked Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. The site is secure. 150 units/kg SC 3 times/week or 40,000 units once weekly. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. maintain desired hemoglobin (Hgb) levels. 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 Evaluate other causes of anemia. most common dosing regimens are 40,000 units weekly for epoetin MeSH The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. The optimal timing and duration of growth factor stimulation has not been determined. *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. endobj FOIA Protect vials and prefilled syringes from light. 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. 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. alfa-treated patients, respectively. Learn how to combine multiple dosing options for precise titration and individualize anemia management. in patients with chronic anemia of cancer as well as CIA document The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. In cancer patients, erythropoietic agents, including Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? therapy. This site complies with the HONcode standard for trust- worthy health information: verify here. A target <>stream 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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Methods: 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). 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. 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 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) endobj In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. stream There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. In the near future, the Pharmacy and Therapeutics The recommended starting doses. This site is intended for U.S. healthcare professionals. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. of patients receiving transfusions was similar between the groups, 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). 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. 2 0 obj PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb 4 x previous weekly epoetin alfa dose (Units)/125. startxref Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . 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. at the Cleveland Clinic Health System (CCHS) reviewing the use of CHO chains) has a 3-fold increase in half-life when compared to 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. Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.. endobj Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. RETACRIT (epoetin alfa-epbx) Dosing Info | Safety Info - Pfizer pro The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and U.S.-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products. 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)]. Avoid frequent dose adjustments. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. 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)]. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Aranesp Dosage Guide - Drugs.com 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). before initiating Aranesp. Scroll left to view table. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Key: Hgb = hemoglobin level, measured in . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Conclusion: Nephrol Dial Transplant. PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. 7. Do not use Aranesp that has been shaken or frozen. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. both groups iron studies were not conducted routinely. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). An official website of the United States government, : A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. <>>> alfa and 200 mcg every 2 weeks for darbepoetin alfa. 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. Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. alfa- and darbepoetin alfa-treated patients, respectively. eCollection 2017. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. deemed epoetin alfa (Procrit; OrthoBiotech) and darbepoetin Aranesp Dosing and Conversion Brochure. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Neulasta should not be used for PBPC mobilization. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Amgen Vol. group. Epub 2005 Dec 6. 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. alfa is as well tolerated and efficacious as epoetin alfa even when <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
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