Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . 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. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. 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. hemoglobin of > 12 g/dL was reached in 47 patients (41%)
this interchange program should be directed to the CCF Department
Do not increase the dose more frequently than once every 4 weeks. More specifically, 23 patients in the epoetin alfa group
Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Clipboard, Search History, and several other advanced features are temporarily unavailable. Conversion from Another ESA: dosed once every 4 weeks based on total interchange, such as patients with chronic renal failure (CRF). The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. conversion factor of 1 mcg:220 units Aranesp:EPO. The recommended starting
active than epoetin alfa, paradoxically was found to have less affinity
Epub 2009 Aug 4. Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). 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. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions, Epoetin alfa products, including RETACRIT, increase the risk of seizures in patients with CKD. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. 4y\@:hT4\j
EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. 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)]. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. 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. %
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Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. 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. at the Cleveland Clinic Health System (CCHS) reviewing the use of
Pussell BA, Walker R; Australian Renal Anaemia Group. Do not re-enter vial. see Tables A and B (below). 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. Methods: therapy. chemotherapy. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. HHS Vulnerability Disclosure, Help 7/2021: added Epogen (nonformulary). If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN
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R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. The .gov means its official.Federal government websites often end in .gov or .mil. 1. 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. Overall, in both groups iron studies were not conducted routinely. -m]|;VB
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MT"_jlhV&AV7^Hiud:.B.4=>^ In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. Approved by FMOLHS P&T. . for epoetin alfa-treated patients and 200 mcg every 2 weeks (or
Use caution in patients with coexistent cardiovascular disease and stroke. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Unable to load your collection due to an error, Unable to load your delegates due to an error. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; affinity has no or little clinical relevance. The information provided is for educational purposes only. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Overall, in
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. An official website of the United States government, : 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). Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin
AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. All Rights Reserved. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. The https:// ensures that you are connecting to the 335 0 obj
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Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . *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 Retacrit has been approved as a biosimilar, not as an interchangeable product. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the Aranesp prefilled syringe, use of the Aranesp vial may be considered. 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. HrsW-D/tCPs. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Adult Respiratory Distress Syndrome (ARDS) Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. 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. Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Supplied Injection, powder for reconstitution: 5 mg, INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. RETACRIT safely and effectively. As a substitute for RBC transfusions in patients who require immediate correction of anemia. 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. Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. 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. 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). When therapy with RETACRITis needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy, In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure, In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion, In patients scheduled for surgery who are willing to donate autologous blood, In patients undergoing cardiac or vascular surgery, As a substitute for RBC transfusions in patients who require immediate correction of anemia, Pure red cell aplasia (PRCA) that begins after treatment with RETACRIT or other erythropoietin protein drugs, Serious allergic reactions to RETACRIT or other epoetin alfa products, Neonates, infants, pregnant women, and lactating women. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first epoetin alfa biosimilar for the treatment of anemia, FDA: Office of Hematology and Oncology Products. alfa. Aranesp Dosing and Conversion Brochure. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. stream
These are recommended
Referrals to independent nonprofitpatient assistance programs. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Before sharing sensitive information, make sure you're on a federal government site. eCollection 2017. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 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)]. k22atr
!h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC 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. 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: 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. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. alfa-treated patients, respectively. erythropoietin, darbepoetin alfa stimulates erythropoiesis. . Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. 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. alfa may be administered as frequently as once every 3 or 4 weeks. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. before initiating Aranesp. Conclusion: Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit Use the lowest dose of Aranesp necessary to avoid RBC transfusions. We comply with the HONcode standard for trustworthy health information. 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). Scroll left to view table. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. 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. b. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. Note: The manufacturer states that, until efficacy/toxicity parameters are established, the use of oprelvekin in pediatric patients (particularly those <12 years of age) should be restricted to use in controlled clinical trials. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Questions regarding
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. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. The products discussed in this site may have different product labeling in different countries. 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. The majority of reported events occurred upon initial exposure. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. Dr. Gerald Diaz @GeraldMD. Would you like email updates of new search results? FOIA Background: 3 0 obj
Pfizer for Professionals 1-800-505-4426 in patients with chronic anemia of cancer as well as CIA document
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. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 1121 0 obj 4 x previous weekly epoetin alfa dose (Units)/125. Depending upon each patient's needs and response, dosage
2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa
patients and 55 darbepoetin alfa patients. Do not dilute. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l alfa- and darbepoetin alfa-treated patients, respectively. Before sharing sensitive information, make sure you're on a federal government site. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. In pediatric patients, Mircera is administered by intravenous injection only (2.2). In patients receiving treatment for cancer and whose anemia is not due to CKD. When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. In CKD, for subcutaneous (SC) administration
Epogen is used in the dialysis area at CCF. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y 0 EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. Call 1-888-4ASSIST to find out more. Accessibility Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). in two ways: 1) Hgb levels > 12 g/dL or 2) an increase
4. Do not shake. 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 gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. of Pharmacy Drug Information Center (216-444-6456, option #1). Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. However, this may result in the over treatment of uraemic anaemia. Refer to Aranesp package insert for pediatric dosing conversion. endstream Decreases in dose can occur more frequently. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Pull the plunger back to the number on the syringe that matches your dose. In the near future, the Pharmacy and Therapeutics
For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g . endobj
Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. The site is secure. A local search option of this data can be found here. Conversion of IV to SC EPO: a. RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . Do not use Aranesp that has been shaken or frozen. epoetin alfa and darbepoetin alfa, have been shown to decrease the
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. Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human . alfa for chronic anemia of cancer and chemotherapy-induced anemia
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. objective of the DUE was to trend usage patterns in the outpatient
Nephrol Dial Transplant. For recommended dose equivalency,
Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Initial U.S. Approval: 2018 . !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X
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DY%--V! The probability of switching between different epoetins was associated with the duration of treatment: about 15 % of users switched within 12 months and almost 25 % within 2 years of observation. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.