Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. 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. alfa is as well tolerated and efficacious as epoetin alfa even when 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. affinity has no or little clinical relevance. (CKD) patients, darbepoetin alfa administered intravenously has 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. overall. stream of Pharmacy Drug Information Center (216-444-6456, option #1). May 15, 2018. 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. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Clipboard, Search History, and several other advanced features are temporarily unavailable. Martnez Castelao A, Reyes A, Valds F, Otero A, Lpez de Novales E, Pallard L, Tabernero JM, Hernndez Jaras J, Llads F. Brunkhorst R, Bommer J, Braun J, Haag-Weber M, Gill C, Wagner J, Wagener T; German Aranesp Study Group. The recommended RETACRIT regimens are: 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. as well). Darbepoetin alfa, although several fold more biologically Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 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. <>>> Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. 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). Neulasta should not be used for PBPC mobilization. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 2 0 obj PMC 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. This site needs JavaScript to work properly. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). endstream Keep the tip of the needle in the RETACRIT liquid. 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. IV If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. 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. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Conclusion: b. 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. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. VII, No. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Existing patients on IV EPO, change to subcutaneous EPO using the . Do not dilute Aranesp and do not administer in conjunction with other drug solutions. Overall, in both groups iron studies were not conducted routinely. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Last updated on Jan 20, 2023. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Neulasta should be permanently discontinued in patients with serious allergic reactions. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . These adverse reactions included myocardial infarction and stroke, In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). The recommended starting dose for pediatric patients (less than 18 years) is 0.45 mcg/kg body weight administered as a single subcutaneous or intravenous injection once weekly; patients not receiving dialysis may be initiated at a dose of 0.75 mcg/kg once every 2 weeks. scMJkP`@SzQ` o3O3Dl6o 8QT-]FjOPa\}m-6(L MAK{kFW-A3]dM36 m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. in patients with chronic anemia of cancer as well as CIA document endstream endobj 336 0 obj <>stream The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. This site complies with the HONcode standard for trust- worthy health information: verify here. Methods: therapy. (CIA) for both outpatients and inpatients. 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)]. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. CHO chains) has a 3-fold increase in half-life when compared to Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Results: The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. endobj Medically reviewed by Drugs.com. 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. Background Anaemia is defined as a reduction of haemoglobin concentration, red . Use caution in patients with coexistent cardiovascular disease and stroke. The products discussed in this site may have different product labeling in different countries. administered less frequently. 2022Pfizer Inc. All rights reserved. 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. 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). In addition, do not mix RETACRIT with bacteriostatic saline (which also contains benzyl alcohol) when administering RETACRIT to these patient populations, Serious and fatal reactions including gasping syndrome can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including RETACRIT multiple-dose vials. of patients receiving transfusions was similar between the groups, for at least 3 weeks between July 2002 and July 2003. Epub 2009 Aug 4. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life of endogenous erythropoietin may be impaired in patients receiving group. Discontinue Aranesp if responsiveness does not improve. Unauthorized use of these marks is strictly prohibited. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh 4. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. 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. Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. 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. 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. Do not mix with other drug solutions. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. 33 Dose. 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. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . 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. 8600 Rockville Pike It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA. RETACRIT is contraindicated in patients with: RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: INCREASED MORTALITY, MYOCARDIAL INFARCTION, STROKE, AND THROMBOEMBOLISM, INCREASED MORTALITY AND/OR INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE IN PATIENTS WITH CANCER, LACK OR LOSS OF HEMOGLOBIN RESPONSE TO RETACRIT, RISK OF SERIOUS ADVERSE REACTIONS DUE TO BENZYL ALCOHOL PRESERVATIVE, ANEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE, ANEMIA DUE TO CHEMOTHERAPY IN PATIENTS WITH CANCER, ANEMIA DUE TO ZIDOVUDINE IN PATIENTS WITH HIV INFECTION, Recommended dosing for adults and children with chronic kidney disease (CKD), The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously (IV) or subcutaneously (SC). RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. The dose should be titrated to meet and _____ (if . Key: Hgb = hemoglobin level, measured in . before initiating Aranesp. Would you like email updates of new search results? Background: More specifically, 23 patients in the epoetin alfa group Darbepoetin alfa. 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. In cancer patients, erythropoietic agents, including 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). No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Recommended regimens for patients undergoing elective, noncardiac, nonvascular surgery, 300 Units/kg per day SC for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery, 600 Units/kg SC in 4 doses, administered 21, 14, and 7 days before surgery and on the day of surgery. Discard unused portion of Aranesp in vials or prefilled syringes. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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)]. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation, and selected end-cell functions (including enhanced phagocytic ability priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and the increased expression of some cell surface antigens). Based on data from this CCHS DUE, darbepoetin alfa and When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. Refer to Aranesp package insert for pediatric dosing conversion. The site is secure. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. 1057 0 obj Update Index. Depending upon each patient's needs and response, dosage RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. 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. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. Evaluate other causes of anemia. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u Both Hb and ferritin concentrations remained within the target range, but darbepoetin dosages fell from 50.8 to 42.3 microg/week by month 3 (P = 0.02). Response rates are defined Studies of erythropoietin therapy <> The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. FOIA Can J Kidney Health Dis. *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. endobj Drug class: recombinant human erythropoietins, Aranesp (Darbepoetin Alfa Prefilled Syringes), Anemia Associated with Chronic Renal Failure, If hemoglobin exceeds a level needed to avoid RBC transfusion, If hemoglobin increases by less than 1 g/dL. %%EOF Do not use Aranesp that has been shaken or frozen. 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. patients and 55 darbepoetin alfa patients. Disclaimer. Aranesp Dosing and Conversion Brochure. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. 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. interchange, such as patients with chronic renal failure (CRF). hemoglobin of > 12 g/dL was reached in 47 patients (41%) %PDF-1.6 % The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ Vu],Ne,z8yT&6Qb6b=bk?+e/d`yo;~B#"z*wd j23#M]\"LFEB(hHQlD5h*}TJwlL{A in Hgb of 2 g/dL from baseline. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). W bO? 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. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. The majority of reported events occurred upon initial exposure. FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicatedfor: Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis 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. Hgb level. 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. Contributed by. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Avoid frequent dose adjustments. Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. Epub 2005 Dec 6. % Epogen is used in the dialysis area at CCF. Overall, only 10.5% of patients had iron studies before erythropoietin Costs Associated With Intravenous Darbepoetin Versus Epoetin Therapy in Hemodialysis Patients: A Randomized Controlled Trial. INDICATIONS AND USAGE Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. While a discounted alternative to Epogen and Procrit is welcome, there is a catch. However, this may result in the over treatment of uraemic anaemia. endobj Rounding doses to the nearest vial size often enhances patient convenience and reduces costs without compromising clinical response. Epogen (Amgen), another brand name for epoetin Wien Med Wochenschr. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. objective of the DUE was to trend usage patterns in the outpatient 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. both groups iron studies were not conducted routinely. 4 0 obj 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. Dosage SubQ: Adolescents >45 kg and Adults: 6 mg once per chemotherapy cycle; do not administer in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy; do not use in patients, infants, children, and smaller adolescents weighing <45 kg. In addition, Hgb levels were Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Previous dosage of epoetin alfa: 2500-4999 units/week, then darbepoetin alfa dosage: 12.5 mcg/week. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. 335 0 obj <>stream The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Maintain the route of administration (intravenous or subcutaneous injection). The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. In the near future, the Pharmacy and Therapeutics PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Evaluate the iron status in all patients before and during treatment. epoetin alfa (3 N-linked CHO chains). !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X T]{oF`S}+c|yt} } ;X'~'6S;3$]K$t/Z1hrL;\qdHBwtKwHUL` z0 DY%--V! A single hemoglobin excursion may not require a dosing change. 1121 0 obj PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 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. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Decreases in dose can occur more frequently. What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. Refer to Table 1. Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. 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. Patient treatments were converted from subcutaneous epoetin alfa to weekly, intravenous darbepoetin alfa at month 0, at a conversion dose of 200 units epoetin alfa to 1 microg darbepoetin. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. In pediatric patients, Mircera is administered by intravenous injection only (2.2). The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. 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. Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). If there are still air bubbles, repeat the steps above to remove them. 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. Slowly push the plunger up to force the air bubbles out of the syringe. These are recommended This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 1022 0 obj Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week.