Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. Endogenous G-CSF is a lineage specific colony-stimulating factor which is produced by monocytes fibroblasts, and endothelial cells. G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage. Pussell BA, Walker R; Australian Renal Anaemia Group. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . (CIA) for both outpatients and inpatients. In addition, Hgb levels were startxref 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. 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. The safety and effectiveness of Neumega have not been established in pediatric patients. 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. Call 1-888-4ASSIST to find out more. This site is intended only for U.S. healthcare professionals. Before sharing sensitive information, make sure you're on a federal government site. 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). When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. The products discussed in this site may have different product labeling in different countries. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l Epub 2016 Mar 4. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 [email protected] n. epoetin alfa (3 N-linked CHO chains). Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dL. Administration Subcutaneously in either the abdomen, thigh, or hip (or upper arm if not self-injected). before initiating Aranesp. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. Q#(@$c *)[-Z-4jtLa-VA&N,1 J"/aNq~tY=r/?wMMOGsq/RJVsj{4p)3$J@jHy\}[AA$AFa>()RQ`20L=Rw8~v9u To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . Can J Kidney Health Dis. Decreases in dose can occur more frequently. 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. alfa for chronic anemia of cancer and chemotherapy-induced anemia 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). 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. b. alfa and 200 mcg every 2 weeks for darbepoetin alfa. Table 1. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. 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. adjustments may be required. Do not use Aranesp that has been shaken or frozen. HrsW-D/tCPs. The information provided is for educational purposes only. chemotherapy. and approved an automatic therapeutic interchange to darbepoetin Use caution in patients with coexistent cardiovascular disease and stroke. Internal Data: A retrospective drug use evaluation (DUE) was conducted Epub 2004 Feb 19. Training should aim to demonstrate to those patients and caregivers how to measure the dose of Aranesp, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for a prefilled syringe. Dr. Gerald Diaz @GeraldMD. sharing sensitive information, make sure youre on a federal No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). and transmitted securely. Do not dilute. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. endobj Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. Mean baseline Hgb levels The .gov means its official.Federal government websites often end in .gov or .mil. official website and that any information you provide is encrypted Overall, only 10.5% of patients had iron studies before erythropoietin Similar to endogenous In the near future, the Pharmacy and Therapeutics Evaluate other causes of anemia. for the erythropoietin receptors, suggesting the slower clearance <> Slowly push the plunger up to force the air bubbles out of the syringe. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. 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. National Library of Medicine Do not mix with other drug solutions. Safety and Efficacy: Currently available data indicate that darbepoetin 2004 May;19(5):1224-30. doi: 10.1093/ndt/gfh106. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. 1022 0 obj The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. Dosage form: injection, solution 1 0 obj eCollection 2017. 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). Production 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. endobj 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). 11 in the epoetin alfa-treated group and 7 in the darbepoetin alfa-treated 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 Learn how to combine multiple dosing options for precise titration and individualize anemia management. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa Based on data from this CCHS DUE, darbepoetin alfa and \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! In pediatric patients, Mircera is administered by intravenous injection only (2.2). An official website of the United States government, : epoetin alfa and darbepoetin alfa for the management of CIA. 4. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Refer to Aranesp package insert for pediatric dosing conversion. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN $l-FRW+>U0pPhRc/N R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" Do not shake. When therapy with RETACRIT is needed in these patient populations, use single-dose vials; do not admix with bacteriostatic saline containing benzyl alcohol, In controlled clinical trials of patients with chronic kidney disease (CKD) comparing higher hemoglobin targets (13 - 14 g/dL) to lower targets (9 - 11.3 g/dL), epoetin alfa increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups, Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. -m]|;VB &mOc{41f*\9x!>b o4pR-Ar|u}u=iS -$ 8\n^l|w,|1K sewEVzhc MT"_jlhV&AV7^Hiud:.B.4=>^ [Multicenter study of darbepoetin alfa in the treatment of anemia secondary to chronic renal insufficiency on dialysis]. The dose should be titrated to meet and or 100 mcg SC once weekly. David McAuley, Pharm.D. Evaluate the iron status in all patients before and during treatment. The most frequent dosing regimens were 40,000 units weekly 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. alfa may be administered as frequently as once every 3 or 4 weeks. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. 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. %PDF-1.6 % RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . every-other-week) for darbepoetin alfa-treated patients. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y The most common side effects of epoetin alfa-treated patients in clinical studies of the reference product were high blood pressure, joint pain, muscle spasm, fever, dizziness, medical device malfunction, blood vessel blockage, respiratory infection, cough, rash, injection site irritation, nausea, vomiting, muscle pain, inflammation of the mouth and lips, weight decrease, reduction in white blood cells, bone pain, high blood sugar, insomnia, headache, depression, difficulty swallowing, low blood potassium, blood clots, itching, headache, injection site pain and chills. contracts, darbepoetin alfa is less expensive than epoetin alfa. levels, and to improve quality of life. Last updated on Jan 20, 2023. Medically reviewed by Drugs.com. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) Check again for air bubbles. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Epub 2014 Aug 14. Avoid frequent dose adjustments. Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. Epogen (Amgen), another brand name for epoetin Use the lowest dose of Aranesp necessary to avoid RBC transfusions. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. FOIA What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? doses. Neulasta should be permanently discontinued in patients with serious allergic reactions. 33 Dose. A single hemoglobin excursion may not require a dosing change. administered less frequently. Keep the tip of the needle in the RETACRIT liquid. Bethesda, MD 20894, Web Policies Key: Hgb = hemoglobin level, measured in . 335 0 obj <>stream Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. group. The intravenous route is recommended for patients on hemodialysis. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. 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. In chronic kidney disease Committee will be exploring other patient populations for this 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. most common dosing regimens are 40,000 units weekly for epoetin SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. 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. A total of When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. 7. 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 k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC half-life of 8.5 hours. Use caution in patients with coexistent cardiovascular disease and stroke. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. for at least 3 weeks between July 2002 and July 2003. Woodland AL, Murphy SW, Curtis BM, Barrett BJ. 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. 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 Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? RETACRIT safely and effectively. The most common dosing regimens are 40,000 units weekly for epoetin alfa and 200 mcg every 2 weeks for darbepoetin alfa. Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. Nephrol Dial Transplant. Referrals to independent nonprofitpatient assistance programs. 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). !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! Overall, in both groups iron studies were not conducted routinely. erythropoietin, darbepoetin alfa stimulates erythropoiesis. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Update Index. 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. Evaluation of Iron Stores and Nutritional Factors. Darbepoetin's T1/2 is approximately 3 times that of epoetin alfa. 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 More specifically, 23 patients in the epoetin alfa group Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. 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. The majority of reported events occurred upon initial exposure. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . lNY0?j/0a6d%J1\3\qdS@*_gy{sl?!H^]ibQ'_(%`lI$5.r U ?Xz:sf;{@(eHB Excessive responses: Hemoglobin increases >1 g/dL in a 2-week period OR if hemoglobin exceeds 12 g/dL: Reduce dose by 25% Hemoglobin >13 g/dL: Withhold dose until hemoglobin falls to 12 g/dL, then reinitiate at 25% less than previous dose. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, 10,000, and 40,000 Units of epoetin alfa-epbx injection contains 0.5 mg of phenylalanine. 1. Aranesp Dosing and Conversion Brochure. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. For recommended dose equivalency, hemoglobin of > 12 g/dL was reached in 47 patients (41%) Response rates are defined Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. Copyright 1993-2021 Aranesp is administered less frequently than epoetin alfa. Based on market share When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. response rates ranging from ~60% to 85%. 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 . However, this may result in the over treatment of uraemic anaemia. The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. 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. 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 adjustments may be required. maintain desired hemoglobin (Hgb) levels. Epoetin alfa. see Tables A and B (below). objective of the DUE was to trend usage patterns in the outpatient Conclusion: 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. Background: 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. The site is secure. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. 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. The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. Monitor platelets and hematocrit regularly. VII, No. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known, Phenylalanine can be harmful to patients with phenylketonuria (PKU). Conversion from Epoetin alfa to Aranesp in patients with CKD not on dialysis. Pull the plunger back to the number on the syringe that matches your dose. All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. endstream 1. Round the dose to the nearest treatment tier. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter. Epogen is used in the dialysis area at CCF. endobj Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. IV Available for Android and iOS devices. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). endstream endobj 336 0 obj <>stream The conversion rate was 354:1 in patients requiring high (>200 IU/kg/week) doses of epoetin and 291:1 in patients requiring low doses. 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. government site. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Darbepoetin alfa, although several fold more biologically If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Accessibility Depending upon each patient's needs and response, dosage The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days.
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