aranesp to retacrit conversion

Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. An official website of the United States government, : Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. interchange, such as patients with chronic renal failure (CRF). Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Overall, in both groups iron studies were not conducted routinely. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of Aranesp or whether the patient would benefit from a different Aranesp presentation. IV 335 0 obj <>stream RETACRIT is contraindicated in patients with: RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM, INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER, LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT, RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE, ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE, ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER, ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION, Recommended dosing for adults and children with chronic kidney disease (CKD), The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously (IV) or subcutaneously (SC). 1057 0 obj . 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 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. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Aranesp Dosing and Conversion Brochure. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . Colony Stimulating Factors - GlobalRPH The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. A target for the erythropoietin receptors, suggesting the slower clearance endobj The most frequent dosing regimens were 40,000 units weekly The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. 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. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. epoetin alfa and darbepoetin alfa, have been shown to decrease the Copyright 1993-2021 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Accessibility 33 Dose. 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. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. Background: Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. An official website of the United States government. Would you like email updates of new search results? in Hgb of 2 g/dL from baseline. Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. The Epoetin alfa. Evaluate other causes of anemia. HHS Vulnerability Disclosure, Help In CKD, for subcutaneous (SC) administration All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Wien Med Wochenschr. 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. and transmitted securely. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. Background Anaemia is defined as a reduction of haemoglobin concentration, red . REASON FOR . Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. eCollection 2017. Do not dilute. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. 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 All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. alfa and 200 mcg every 2 weeks for darbepoetin alfa. of Pharmacy Drug Information Center (216-444-6456, option #1). The implementation date for the interchange program is October 11, 2004. Pharmacotherapy Update - Automatic Therapeutic Interchange Program Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) IL-11 has also been shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. Ann Pharmacother. Depending upon each patient's needs and response, dosage adjustments may be required. MeSH 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. endobj Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. epoetin alfa produce similar Hgb levels in patients with CIA. Epogen is used in the dialysis area at CCF. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. <> However, this may result in the over treatment of uraemic anaemia. Key: Hgb = hemoglobin level, measured in . About The Cleveland Clinic Center for Continuing Education, Regularly Scheduled Series (RSS) Registration, Regulary Scheduled Series (RSS) Schedule (pdf), Disease Management Project Clinical Decisions Cases, Managing Problem Patients with Anti-TNF Inhibitors, Emerging Therapies in Heart Disease Webcast Series. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Both Hb and ferritin concentrations remained within the target range, but darbepoetin dosages fell from 50.8 to 42.3 microg/week by month 3 (P = 0.02). Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Medically reviewed by Drugs.com. 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. 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. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. 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. at the Cleveland Clinic Health System (CCHS) reviewing the use of %PDF-1.6 % 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). *Z?PkIV/X8$yN7.7 _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disease should prescribe Neulasta for such patients, and only after careful consideration of the potential risks and benefits. Conversion of IV to SC EPO: a. Refer to Table 1. Results: Can J Kidney Health Dis. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 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. of patients receiving transfusions was similar between the groups, 4 0 obj The site is secure. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. endstream endobj 336 0 obj <>stream Based on market share Decreases in dose can occur more frequently. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X T]{oF`S}+c|yt} } ;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL` z0 DY%--V! Scroll left to view table. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Internal Data: A retrospective drug use evaluation (DUE) was conducted 4. The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. Based on data from this CCHS DUE, darbepoetin alfa and PDF Food and Drug Administration 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Monitor platelets and hematocrit regularly. 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. A local search option of this data can be found here. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Federal government websites often end in .gov or .mil. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Response rates are defined 1. If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions. In pediatric patients, Mircera is administered by intravenous injection only (2.2). epoetin alfa and darbepoetin alfa for the management of CIA. Epub 2005 Dec 6. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. The optimal timing and duration of growth factor stimulation has not been determined. Aranesp (darbepoetin alfa) | Dosing Considerations PDF Aranesp (Darbepoetin alfa) Label - Food and Drug Administration 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. <> No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. The information provided is for educational purposes only. 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)]. conversion factor of 1 mcg:220 units Aranesp:EPO. Do not use Aranesp that has been shaken or frozen. Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. May 15, 2018. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. a half-life of 25.3 hours compared to epoetin alfa, which has a Check again for air bubbles. 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 $994.98 for the AWP for a 3 mcg/kg dose every other week). : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Discontinue Aranesp if responsiveness does not improve. Do not increase the dose more frequently than once every 4 weeks. However, this may result in the over treatment of uraemic anaemia. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. RETACRIT Instructions For Use (epoetin alfa-epbx) endobj Slowly push the plunger up to force the air bubbles out of the syringe. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL of the molecule is a more important determinant of potency and receptor %PDF-1.5 for at least 3 weeks between July 2002 and July 2003. 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. Evaluate the iron status in all patients before and during treatment. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. Safety and Efficacy: Currently available data indicate that darbepoetin RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) For recommended dose equivalency, The average Protect vials and prefilled syringes from light. RETACRIT is a registered trademark of Pfizer Inc. Epogen is a registered trademark of Amgen Inc. Procrit is a registered trademark of Janssen Products, LP. RETACRIT (epoetin alfa-epbx) Dosing Info | Safety Info - Pfizer pro hemoglobin of > 12 g/dL was reached in 47 patients (41%) 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. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6 r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* 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). 7. Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. endobj adjustments may be required. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). As a substitute for RBC transfusions in patients who require immediate correction of anemia. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. %%EOF both groups iron studies were not conducted routinely. b. What is the difference between Retacrit and Procrit? - Drugs.com Epub 2009 Aug 4. Recommended regimens for patients undergoing elective, noncardiac, nonvascular surgery, 300 Units/kg per day SC for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery, 600 Units/kg SC in 4 doses, administered 21, 14, and 7 days before surgery and on the day of surgery.

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