The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 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. Check again for air bubbles. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 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. 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. arena for dosing, dosing interval, hemoglobin levels, number of at the Cleveland Clinic Health System (CCHS) reviewing the use of Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. The information provided is for educational purposes only. hemoglobin of > 12 g/dL was reached in 47 patients (41%) No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. For adult patients with CKD not on dialysis: When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2). number of patients receiving transfusions, to increase hemoglobin Round the dose to the nearest treatment tier. The optimal timing and duration of growth factor stimulation has not been determined. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. government site. overall. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. 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). %PDF-1.6 % Epub 2014 Aug 14. Epogen is used in the dialysis area at CCF. VII, No. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Epub 2016 Mar 4. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life 150 units/kg SC 3 times/week or 40,000 units once weekly. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. 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. 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 . Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa The average What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 7. Hymes J, Bickimer T, Jackson JH, Bookhart BK, Mody SH, Tak Piech C. Curr Med Res Opin. Darbepoetin alfa, although several fold more biologically The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week IV This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. All Rights Reserved. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Hgb level. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). Neulasta should be permanently discontinued in patients with serious allergic reactions. 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. 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN $l-FRW+>U0pPhRc/N R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefits. An official website of the United States government. Vol. Call 1-888-4ASSIST to find out more. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. July/August 2004, Return to The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh 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. Do not dilute. Based on data from this CCHS DUE, darbepoetin alfa and ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Evaluate other causes of anemia. 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. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. 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. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. 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). 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%. Internal Data: A retrospective drug use evaluation (DUE) was conducted National Library of Medicine Careers. most common dosing regimens are 40,000 units weekly for epoetin 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 . There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. The If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. 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 . endstream endobj 336 0 obj <>stream Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Slowly push the plunger up to force the air bubbles out of the syringe. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. Evaluate the iron status in all patients before and during treatment. Use the lowest dose of Aranesp necessary to avoid RBC transfusions. Do not use Aranesp that has been shaken or frozen. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. 7/2021: added Epogen (nonformulary). see Tables A and B (below). HrsW-D/tCPs. 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)]. amina and sarah said funeral,