aranesp to retacrit conversion

alfa is as well tolerated and efficacious as epoetin alfa even when Last updated on Jan 20, 2023. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). in patients with chronic anemia of cancer as well as CIA document 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. Pharmacotherapy 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. alfa. The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. Table 1. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. doses. 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 kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Dosage form: injection, solution Pussell BA, Walker R; Australian Renal Anaemia Group. 1022 0 obj In addition, at this time, this interchange program does not affect >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r SN:]AW&g{auwi(D)Si'(EK 9P$a8d_R/au&tIk=[A'"Uh 5E~"{dC4dMs/*e?&Io}a\d05zVJ)~OL:MK'tiM>)r4zoBp`Vju`'78f4*q-PFa_,R2(r\?ASM^B6DT&s+IfUSqS6H5l~b)lMx:'j_sT[.q"ju g/8f5>tWw]}vAQNK0: st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c %PDF-1.6 % Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. 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. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. 7. Darbepoetin alfa, although several fold more biologically Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? Follow the Oncology Center of Excellence on Twitter @FDAOncology. Conversion of IV to SC EPO: a. ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu RETACRIT Instructions For Use (epoetin alfa-epbx) Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life Methods: alfa and 200 mcg every 2 weeks for darbepoetin alfa. Please enable it to take advantage of the complete set of features! 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)]. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks . Unauthorized use of these marks is strictly prohibited. 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. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or 2.25 mcg/kg every week subcutaneously until completion of a chemotherapy course. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. 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. 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. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) Do not increase the dose more frequently than once every 4 weeks. 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. Pfizer for Professionals 1-800-505-4426 Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. Disclaimer. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products, said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff in the FDAs Center for Drug Evaluation and Research. In addition, Hgb levels were Epoetin alfa (Epogen, Procrit) and its biosimilar, epoetin alfa-epbx (Retacrit), are erythropoiesis-stimulating agents (ESAs). 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. for at least 3 weeks between July 2002 and July 2003. The 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. administered less frequently. 1057 0 obj At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee Slowly push the plunger up to force the air bubbles out of the syringe. Reduce or withhold RETACRIT if blood pressure becomes difficult to control. and transmitted securely. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa patients and 55 darbepoetin alfa patients. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. 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. alfa for chronic anemia of cancer and chemotherapy-induced anemia Epogen (Amgen), another brand name for epoetin 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. However, this may result in the over treatment of uraemic anaemia. 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). Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. %PDF-1.5 both groups iron studies were not conducted routinely. The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Retacrit has not been shown to be interchangeable with U.S.-licensed Epogen/Procrit. No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Careers. The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30/ 31days. 4 x previous weekly epoetin alfa dose (Units)/125. half-life of 8.5 hours. patients had to be initiated on epoetin alfa or darbepoetin alfa Referrals to independent nonprofitpatient assistance programs. Keep the tip of the needle in the RETACRIT liquid. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin Mean baseline Hgb levels . at the Cleveland Clinic Health System (CCHS) reviewing the use of In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient hemoglobin response to RETACRIT therapy, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with epoetin alfa. 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. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. 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). Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. Epub 2016 Mar 4. HHS Vulnerability Disclosure, Help Hgb level. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. Aranesp (darbepoetin alfa) | Dosing Considerations If patient does not respond, a response to higher doses is unlikely. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). of the molecule is a more important determinant of potency and receptor 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. A total of The implementation date for the interchange program is October 11, 2004. Similar to endogenous 33 Dose. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. The dose should be titrated to meet and For recommended dose equivalency, Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dL. Do not dilute. MeSH Alternative dose: 600 units/kg in once weekly doses (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. (CIA) for both outpatients and inpatients. Round the dose to the nearest treatment tier. government site. <> Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Based on market share IL-11 has also been shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. Before This site is intended only for U.S. healthcare professionals. 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 In cancer patients, erythropoietic agents, including CHO chains) has a 3-fold increase in half-life when compared to SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. However, this may result in the over treatment of uraemic anaemia. Recommended dosing for adults and children with chronic kidney disease (CKD) For adult patients with CKD on dialysis: every-other-week) for darbepoetin alfa-treated patients. 1 0 obj endobj General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies.