U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN $l-FRW+>U0pPhRc/N R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" *Z?PkIV/X8$yN7.7 Do not use Aranesp that has been shaken or frozen. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. stream 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. 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). Keep the tip of the needle in the RETACRIT liquid. 4. Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. The .gov means its official.Federal government websites often end in .gov or .mil. both groups iron studies were not conducted routinely. 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). This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. A local search option of this data can be found here. of endogenous erythropoietin may be impaired in patients receiving Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . Can J Kidney Health Dis. Unauthorized use of these marks is strictly prohibited. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Copyright 1993-2021 PMC Would you like email updates of new search results? k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Evaluation of Iron Stores and Nutritional Factors. This site is intended for U.S. healthcare professionals. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks, In controlled clinical trials of patients with cancer, epoetin alfa increased the risks for death and serious adverse cardiovascular reactions. HHS Vulnerability Disclosure, Help Do Not Copy, Distribute or otherwise Disseminate without express permission. Evaluate other causes of anemia. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. 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). 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. In patients receiving treatment for cancer and whose anemia is not due to CKD. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. The .gov means its official. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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) At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee This site complies with the HONcode standard for trust- worthy health information: verify here. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, and 40,000 Units of epoetin alfa-epbx injection contains 0.5 mg of phenylalanine. _____ (if . -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ levels, and to improve quality of life. Epub 2009 Aug 4. every-other-week) for darbepoetin alfa-treated patients. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. official website and that any information you provide is encrypted or 100 mcg SC once weekly. 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). Refer to Aranesp package insert for pediatric dosing conversion. 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). as well). RETACRIT safely and effectively. If patient does not respond, a response to higher doses is unlikely. 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. Mean baseline Hgb levels 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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. May 15, 2018. for the erythropoietin receptors, suggesting the slower clearance of the molecule is a more important determinant of potency and receptor Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Referrals to independent nonprofitpatient assistance programs. Select one or more newsletters to continue. 4 0 obj These are recommended Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. before initiating Aranesp. Careers. 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. 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. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). 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 . Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. REASON FOR . Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. The recommended starting dose for pediatric patients (less than 18 years) is 0.45 mcg/kg body weight administered as a single subcutaneous or intravenous injection once weekly; patients not receiving dialysis may be initiated at a dose of 0.75 mcg/kg once every 2 weeks. Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary to treat anemia associated with myelodysplastic syndromes when the following criteria are met: 2, 3,8,9,32,46 . 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. Background Anaemia is defined as a reduction of haemoglobin concentration, red . The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Discontinue RETACRIT therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected, RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated for use in neonates, infants, pregnant women, and lactating women. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Questions regarding Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. W bO? 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. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Protect vials and prefilled syringes from light. Committee will be exploring other patient populations for this Check again for air bubbles. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. 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. Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Epub 2005 Dec 6. Do not re-enter vial. Last updated on Jan 20, 2023. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). 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 implementation date for the interchange program is October 11, 2004. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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. The safety and effectiveness of Neumega have not been established in pediatric patients. Immediately and permanently discontinue RETACRIT and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs, Blistering and skin exfoliation reactions, including erythema multiforme and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported in patients treated with ESAs (including epoetin alfa) in the postmarketing setting. 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)]. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. 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). most common dosing regimens are 40,000 units weekly for epoetin The majority of patients with CKD will require supplemental iron during the course of ESA therapy. gs+"!y]|"bA=!ZuP xrYB5 EXrL5I'DG(^=9QC4L" VtO!.P/Ndt:U!Vl-6X4&?jv_V'rX:!p[? RETACRIT single-dose vials contain phenylalanine, a component of aspartame. Training should aim to demonstrate to those patients and caregivers how to measure the dose of Aranesp, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for a prefilled syringe. endobj Available for Android and iOS devices. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. In addition, Hgb levels were As a substitute for RBC transfusions in patients who require immediate correction of anemia. [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. Darbepoetin alfa (5 N-linked 0 This site needs JavaScript to work properly. 335 0 obj <>stream half-life of 8.5 hours. 1121 0 obj The site is secure. 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. 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. epoetin alfa produce similar Hgb levels in patients with CIA. A total of Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. affinity has no or little clinical relevance. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. 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. . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy ZARXIO is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)]. Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). The site is secure. 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. 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).
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