2014 Oct;46(10):1983-95. doi: 10.1007/s11255-014-0800-4. However, this may result in the over treatment of uraemic anaemia. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. The most frequent dosing regimens were 40,000 units weekly
Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. %PDF-1.6
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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. If patient does not respond, a response to higher doses is unlikely. Based on market share
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 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
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r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* We comply with the HONcode standard for trustworthy health information. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin
Refer to Table 1. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Do not re-enter vial. %
Nephrol Dial Transplant. Adverse effects on PFS and/or OS were observed in studies of patients receiving chemotherapy for breast cancer, lymphoid malignancy, and cervical cancer; in patients with advanced head and neck cancer receiving radiation therapy; and in patients with non-small cell lung cancer or various malignancies who were not receiving chemotherapy or radiotherapy, RETACRIT is contraindicated in patients with uncontrolled hypertension. Vol. The majority of reported events occurred upon initial exposure. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Overall, in both groups iron studies were not conducted routinely. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. Approved by FMOLHS P&T. . startxref Severe chronic neutropenia: Congenital: 6 mcg/kg twice daily Idiopathic/cyclic: 5 mcg/kg/day, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9222, Supplied: Injection, solution [preservative free]: 300 mcg/mL (1 mL, 1.6 mL) [vial; contains sodium 0.035 mg/mL and sorbitol], Injection, solution [preservative free]: 600 mcg/mL (0.5 mL, 0.8 mL) [prefilled Singleject syringe; contains sodium 0.035 mg/mL and sorbitol], Drug UPDATES: ZARXIO - filgrastim-sndz injection [Drug information / PDF] Click link for the latest monographDosing: Click (+) next to Dosage and Administration section (drug info link). 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 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. 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. Epoetin alfa. Please review the latest applicable package insert for additional information and possible updates. Medically reviewed by Drugs.com. 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). 33 Dose. Safety and Efficacy: Currently available data indicate that darbepoetin
epoetin alfa produce similar Hgb levels in patients with CIA. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. In chronic kidney disease
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R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" In CKD, for subcutaneous (SC) administration
group. of the molecule is a more important determinant of potency and receptor
Pharmacotherapy
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. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. 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. 150 units/kg SC 3 times/week or 40,000 units once weekly. 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. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. Studies of erythropoietin therapy
The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. 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. 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. Round the dose to the nearest treatment tier. transfusions, and iron studies. 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. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . Epub 2004 Feb 19. 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. 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 safety and effectiveness of Neumega have not been established in pediatric patients. The average
Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Pussell BA, Walker R; Australian Renal Anaemia Group. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. affinity has no or little clinical relevance. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. government site. Table 1. therapy. Committee will be exploring other patient populations for this
Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r
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st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. patients and 55 darbepoetin alfa patients. May 15, 2018. These are recommended doses. 1022 0 obj Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. -m]|;VB
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MT"_jlhV&AV7^Hiud:.B.4=>^ EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Use caution in patients with coexistent cardiovascular disease and stroke. response rates ranging from ~60% to 85%. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. Response rates are defined
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e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. this interchange program should be directed to the CCF Department
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. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Depending upon each patient's needs and response, dosage
Overall, in
Dr. Gerald Diaz @GeraldMD. Based on data from this CCHS DUE, darbepoetin alfa and
FOIA Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. _
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2022Pfizer Inc. All rights reserved. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. Do Not Copy, Distribute or otherwise Disseminate without express permission. arena for dosing, dosing interval, hemoglobin levels, number of
in Hgb of 2 g/dL from baseline. Discontinue Aranesp if responsiveness does not improve. 4 x previous weekly epoetin alfa dose (Units)/125. VII, No. Check again for air bubbles. This site is intended only 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. G-CSF is not species specific and has been shown to have minimal direct in vivo or in vitro effects on the production of hematopoietic cell types other than the neutrophil lineage. 1 0 obj
If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. 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. Serious allergic reactions to OMONTYS. 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. Evaluation of Iron Stores and Nutritional Factors. In order to be included in the DUE,
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. Background: b. All Rights Reserved. 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 . The site is secure. 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. (CKD) patients, darbepoetin alfa administered intravenously has
Ann Pharmacother. 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. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. alfa- and darbepoetin alfa-treated patients, respectively. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. alfa for chronic anemia of cancer and chemotherapy-induced anemia
Retacrit has been approved as a biosimilar, not as an interchangeable product. Referrals to independent nonprofitpatient assistance programs. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. CHO chains) has a 3-fold increase in half-life when compared to
Maintain the route of administration (intravenous or subcutaneous injection). 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. Do not increase the dose more frequently than once every 4 weeks. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. stream
After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. 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. HrsW-D/tCPs. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. David McAuley, Pharm.D. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). Scroll left to view table. 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. 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 . 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.