EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . In addition, Hgb levels were
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Careers. 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)]. Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Darbepoetin alfa, although several fold more biologically
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. This site complies with the HONcode standard for trust- worthy health information: verify here. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. 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). Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 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. Before prescribing RETACRIT single-dose vials to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including RETACRIT, Patients may require adjustments in their dialysis prescriptions after initiation of RETACRIT. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. <>
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PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa 7. Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol. 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. Before sharing sensitive information, make sure you're on a federal government site. Do not mix with other drug solutions. 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. Hgb level. 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). 2. 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. 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. Maintain the route of administration (intravenous or subcutaneous injection). Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. In the near future, the Pharmacy and Therapeutics
Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. 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.
Evaluation of Iron Stores and Nutritional Factors. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. 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). The majority of reported events occurred upon initial exposure. Aranesp is administered less frequently than epoetin alfa. 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 The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. transfusions, and iron studies. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Referrals to independent nonprofitpatient assistance programs. An official website of the United States government. Aranesp Dosing and Conversion Brochure. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Do not increase the dose more frequently than once every 4 weeks. The .gov means its official.Federal government websites often end in .gov or .mil. epoetin alfa produce similar Hgb levels in patients with CIA. 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 This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 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 | European Medicines Agency DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x.
(PDF) Conversion from epoetin beta to darbepoetin: What is the 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g.febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. Can J Kidney Health Dis. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Do not dilute. 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. PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which RETACRIT is not approved). Hypertension: Control hypertension prior to initiating and during treatment with OMONTYS. Slowly push the plunger up to force the air bubbles out of the syringe.
Darbepoetin alfa (Aranesp) Place of Service Hospital Administration Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Dosage form: injection, solution Epogen and Procrit are specialty medications used to treat anemia caused by chronic kidney disease (CKD) or chemotherapy, but they don't come cheap. therapy.
FDA approves Retacrit as a biosimilar to Epogen/Procrit | FDA Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. %%EOF All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. this interchange program should be directed to the CCF Department
The majority of patients with CKD will require supplemental iron during the course of erythropoiesis-stimulating agent therapy. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. Following initiation and titration of epoetin alfa, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving RETACRIT, Appropriately control hypertension prior to initiation of and during treatment with RETACRIT. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Unauthorized use of these marks is strictly prohibited. endobj 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. Would you like email updates of new search results? Existing patients on IV EPO, change to subcutaneous EPO using the . 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. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . alfa is as well tolerated and efficacious as epoetin alfa even when
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Refer to Table 1. of patients receiving transfusions was similar between the groups,
Learn how to combine multiple dosing options for precise titration and individualize anemia management. Darbepoetin alfa.
Amgen 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. Do not shake. 4. 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. Use caution in patients with coexistent cardiovascular disease and stroke. Inclusion Criteria: - Subjects who are greater than 6 months post-renal transplant (living or cadaveric) - Using adequate contraceptive precaution, if of childbearing potential - Available for follow-up assessments and dosing visits - Hb concentration less than 11.0 g/dL within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period Exclusion Criteria . Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. 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. alfa (Aranesp; Amgen) to be therapeutic equivalent products
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. similar over the course of therapy for both groups. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Round the dose to the nearest treatment tier. zi){#_YD2}y5g{b_qh3d{~"/7{k~} }^?>~4LF=,q\Qnw/UUuQTN /Bu*"=rl w.WO/I:$woS'/rmG
M/d=w+6E/pB)OOq5A:P+o{ K2`._iD6vGfch>PN/VTH3|GH-a/D}-J"{6Mj9K`a2'> Iltm< Adults: 50 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/uL). 335 0 obj
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Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. response rates ranging from ~60% to 85%. %PDF-1.5
Zhang L, Coombes J, Pascoe EM, Badve SV, Dalziel K, Cass A, Clarke P, Ferrari P, McDonald SP, Morrish AT, Pedagogos E, Perkovic V, Reidlinger D, Scaria A, Walker R, Vergara LA, Hawley CM, Johnson DW, On Behalf Of The Hero Study Collaborative Group. *Z?PkIV/X8$yN7.7 Update Index. Epub 2014 Aug 14. Epogen (Amgen), another brand name for epoetin
Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). scMJkP`@SzQ`
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PDF Food and Drug Administration Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) As a substitute for RBC transfusions in patients who require immediate correction of anemia. Select one or more newsletters to continue. Conversion from Another ESA: dosed once every 4 weeks based on total Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit RETACRIT is a registered trademark of Pfizer Inc. Epogen is a registered trademark of Amgen Inc. Procrit is a registered trademark of Janssen Products, LP. CHO chains) has a 3-fold increase in half-life when compared to
epoetin alfa and darbepoetin alfa for the management of CIA.
David McAuley, Pharm.D. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. In patients receiving treatment for cancer and whose anemia is not due to CKD. PMC The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Avoid frequent dose adjustments. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Monitor platelets and hematocrit regularly. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes fibroblasts, and endothelial cells.
RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) Last updated on Jan 20, 2023. 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. This site is intended only for U.S. healthcare professionals. 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. conversion factor of 1 mcg:220 units Aranesp:EPO. group. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery. at the Cleveland Clinic Health System (CCHS) reviewing the use of
Overall, only 10.5% of patients had iron studies before erythropoietin
SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. b. a half-life of 25.3 hours compared to epoetin alfa, which has a
RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE .
Colony Stimulating Factors - GlobalRPH 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.