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. 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. contracts, darbepoetin alfa is less expensive than epoetin alfa. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. Aranesp is administered less frequently than epoetin alfa. 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g.febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream
This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. conversion factor of 1 mcg:220 units Aranesp:EPO. %
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Limitations of Use OMONTYS is not indicated and is not recommended for use: In patients with CKD not on dialysis . Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. 33 Dose. objective of the DUE was to trend usage patterns in the outpatient
Ann Pharmacother. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. . Do not mix with other drug solutions. Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Use caution in patients with coexistent cardiovascular disease and stroke. government site. Darbepoetin alfa, although several fold more biologically
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If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. In cancer patients, erythropoietic agents, including
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. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. Depending upon each patient's needs and response, dosage
Surgery patients: Prior to initiating treatment, obtain a hemoglobin to establish that is >10 mg/dL or 13 mg/dL: Initial dose: 300 units/kg/day SC x 10 days before surgery, on the day of surgery, and for 4 days after surgery. most common dosing regimens are 40,000 units weekly for epoetin
a half-life of 25.3 hours compared to epoetin alfa, which has a
Neulasta should be permanently discontinued in patients with serious allergic reactions. 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 . 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) 1 0 obj
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. Use caution in patients with coexistent cardiovascular disease and stroke. Before Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Epub 2009 Aug 4. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. 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. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Dose adjustment: If response is not satisfactory after a sufficient period of evaluation (8 weeks of 3 times/week and 4 weeks of once weekly therapy), the dose may be increased every 4 weeks (or longer) up to 300 units/kg 3 times/week, or when dosed weekly, increased all at once to 60,000 units weekly. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee
Darbepoetin alfa. The
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. To report an adverse event, please call 1-800-438-1985. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. Bookshelf e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. of the molecule is a more important determinant of potency and receptor
Aranesp Dosing and Conversion Brochure. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. see Tables A and B (below). Evaluate the iron status in all patients before and during treatment. Response rates are defined
Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Table 1. Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. Federal government websites often end in .gov or .mil. interchange, such as patients with chronic renal failure (CRF). Copyright 1993-2021 epoetin alfa produce similar Hgb levels in patients with CIA. %%EOF These are recommended doses. 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. Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Do not dilute. If patient has not responded satisfactorily to a 300 unit/kg dose 3 times/week, a response to higher doses is unlikely. Before sharing sensitive information, make sure you're on a federal government site. Before sharing sensitive information, make sure you're on a federal government site. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. 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 . Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. The implementation date for the interchange program is October 11, 2004. 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. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. The
Please review the latest applicable package insert for additional information and possible updates. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Existing patients on IV EPO, change to subcutaneous EPO using the . Scroll left to view table. 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
This site complies with the HONcode standard for trust- worthy health information: verify here. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. official website and that any information you provide is encrypted of endogenous erythropoietin may be impaired in patients receiving
Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 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 Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
Conversion of IV to SC EPO: a. %PDF-1.6
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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 . %PDF-1.6
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<> Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. IV
1121 0 obj patients and 55 darbepoetin alfa patients. alfa. similar over the course of therapy for both groups. Epub 2014 Jan 31. This site is intended only for U.S. healthcare professionals. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or
Following initiation and titration of epoetin alfa, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving RETACRIT, Appropriately control hypertension prior to initiation of and during treatment with RETACRIT. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. alfa for chronic anemia of cancer and chemotherapy-induced anemia
Avoid frequent dose adjustments. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Available for Android and iOS devices. Adjust dose as follows to achieve and maintain a target hemoglobin: Inadequate response: Hemoglobin increases <1 g/dL after 6 weeks of therapy: Increase dose to 4.5 mcg/kg. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. 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. endobj
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. David McAuley, Pharm.D. and 24 patients in the darbepoetin alfa group reached the targeted
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Select one or more newsletters to continue. 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 . 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.