PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna In CKD, for subcutaneous (SC) administration
Evaluate other causes of anemia. Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions. FDA Approves Cheaper Alternative to Specialty Anemia Drugs - GoodRx 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. Decreases in dose can occur more frequently. Darbepoetin alfa. %PDF-1.6
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600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: Overall, in
If hemoglobin increases greater than 1 g/dL in any 2-week period or, If hemoglobin reaches a level needed to avoid RBC transfusion, Withhold dose until hemoglobin approaches a level where RBC transfusions may be required, Reinitiate at a dose 40% below the previous dose, If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy, Following completion of a chemotherapy course. Clipboard, Search History, and several other advanced features are temporarily unavailable. adjustments may be required. Neulasta should be permanently discontinued in patients with serious allergic reactions. 150 units/kg SC 3 times/week or 40,000 units once weekly. 1121 0 obj in two ways: 1) Hgb levels > 12 g/dL or 2) an increase
HrsW-D/tCPs. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. 1. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aranesp Dosing and Conversion Brochure. Excessive response: Hemoglobin increases >1 g/dL in any 2-week period: Decrease dose Hemoglobin increases and approaches the target value of 12 g/dL: Decrease weekly dosage by ~25%. PMC alfa may be administered as frequently as once every 3 or 4 weeks. Dosage form: injection, solution 3 0 obj
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. most common dosing regimens are 40,000 units weekly for epoetin
The IV route is recommended for patients on hemodialysis, For adult patients with CKD not on dialysis, The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly IV or SC, The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly IV or SC, Recommended dosing for patients with HIV treated with zidovudine, The recommended starting dose in adults is 100 Units/kg as an IV or SC injection 3 times per week, If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid red blood cell (RBC) transfusions or 300 Units/kg, Recommended starting dose for adults and children undergoing cancer chemotherapy*, 150 Units/kg SC 3 times per week until completion of a chemotherapy course, or, 40,000 Units SC weekly until completion of a chemotherapy course, 600 Units/kg IV weekly until completion of a chemotherapy course. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. 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. Pull the plunger back to the number on the syringe that matches your dose. Careers. Epogen (Amgen), another brand name for epoetin
DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta To report an adverse event, please call 1-800-438-1985. Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). RETACRIT Instructions For Use (epoetin alfa-epbx) These are recommended
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Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. An official website of the United States government. VII, No. Scroll left to view table. A target
response rates ranging from ~60% to 85%. Nephrol Dial Transplant. The dose should be titrated to meet and
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m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ 1. David McAuley, Pharm.D. The safety and effectiveness of Neumega have not been established in pediatric patients. and transmitted securely. Do not use any vials or prefilled syringes exhibiting particulate matter or discoloration. Results: Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. We comply with the HONcode standard for trustworthy health information. Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. Medically reviewed by Drugs.com. Epub 2004 Feb 19. Approved by FMOLHS P&T. . 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. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA MIRCERA can be administered once every 2 weeks or once monthly to patients whose hemoglobin has been stabilized by treatment with an ESA. as well). Call 1-888-4ASSIST to find out more. Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW Do not shake. Increase dose by 50-100 units/kg 3 times/week if response is not satisfactory in terms of reducing transfusion requirements or increasing hemoglobin after 8 weeks of therapy. every-other-week) for darbepoetin alfa-treated patients. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Patients on Cancer Chemotherapy Initiate Aranesp in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned 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. 335 0 obj
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Key: Hgb = hemoglobin level, measured in . 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. >/@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 In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. 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 . 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. administered less frequently. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Epub 2009 Aug 4. See full prescribing information for RETACRIT. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. 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. 4. 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. endobj
Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. 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). Hgb level. 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. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells. of Pharmacy Drug Information Center (216-444-6456, option #1). 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. 4 x previous weekly epoetin alfa dose (Units)/125. Use caution in patients with coexistent cardiovascular disease and stroke. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. Committee will be exploring other patient populations for this
Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance 0 Maintain the route of administration (intravenous or subcutaneous injection). What is the practical conversion dose when changing from epoetin alfa startxref Epogen (epoetin alfa)injection, for intravenous or subcutaneous use Initial U.S.Approval: 1989 WARNING:ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. levels, and to improve quality of life. A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. Based on market share
PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa The recommended starting
CONTRAINDICATIONS Neumega is contraindicated in patients with a history of hypersensitivity to Neumega or any component of the product, Dosage SubQ: Note: First dose should not be administered until 24-36 hours after the end of chemotherapy. 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. The site is secure. Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1). The average
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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion (2.2). 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Epub 2014 Jan 31. Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u 2 0 obj
Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. Select one or more newsletters to continue. Do not re-enter vial. Aranesp is the only long-acting erythropoiesis-stimulating agent (ESA) approved for both once weekly (QW) and once every three weeks (Q3W) dosing 1, 2 Aranesp dosing options of QW or Q3W may allow for synchronization with common myelosuppressive chemotherapy regimens. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. Epub 2005 Dec 6. "9hu2,yUHZC]r}P(j 5{O$Mv$5O6
r~_RMN: 2YSkk.g_GCUswyDxD5m#):`1#V0O_>$gpz~Q5I^D6u'R52O Ou>dteJB* 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. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. 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. 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. 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. of the molecule is a more important determinant of potency and receptor
RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves Retacrit as a biosimilar to Epogen/Procrit, Drug Information Soundcast in Clinical Oncology. A single hemoglobin excursion may not require a dosing change. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. The most frequent dosing regimens were 40,000 units weekly
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. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. ChronicKidney Disease: Mircera Dosage Guide - Drugs.com The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. and 24 patients in the darbepoetin alfa group reached the targeted
Before National Library of Medicine (PDF) Conversion from epoetin beta to darbepoetin: What is the Conversion - Epoetin alfa (Procrit) to Darbepoetin alfa (Aranesp) #Epoetin #Darbepoetin #Erythropoietin #Conversion #Table #ESAs #Procrit #Aranesp #Pharmacology #Hematology #Nephrology. Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast. Unauthorized use of these marks is strictly prohibited. endstream
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Background: Do not dilute. Both Retacrit and Procrit are approved for treatment of anemia caused by chronic kidney disease, chemotherapy, use of zidovudine in patients with HIV, and before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery. Methods: endstream _
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Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit this interchange program should be directed to the CCF Department
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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. Monitor platelets and hematocrit regularly. The information provided is for educational purposes only. Discard unused portion of Aranesp in vials or prefilled syringes. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. <>/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
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.