May 15, 2018. Northwest Kidney Centers Home Dialysis Programs Standing Orders - Erythropoietin . 4. Questions regarding alfa- and darbepoetin alfa-treated patients, respectively. Based on the patient's response, darbepoetin The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. The optimal timing and duration of growth factor stimulation has not been determined. Slowly push the plunger up to force the air bubbles out of the syringe. 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. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y In patients who are receiving epoetin alfa once weekly, darbepoetin should be administered once every 2 weeks. number of patients receiving transfusions, to increase hemoglobin Neulasta should be permanently discontinued in patients with serious allergic reactions. Depending upon each patient's needs and response, dosage _____ (if . The protocol for anaemia management included a target haemoglobin (Hb) concentration of 120-130 g/L and a ferritin of 300-600 microg/L. 4. Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. 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 Australian haemodialysis patients on intravenous epoetin alfa or intravenous darbepoetin alfa: how do they compare? The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. Update Index. 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. 2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097. In the near future, the Pharmacy and Therapeutics e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. Individualize dosing and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . Committee will be exploring other patient populations for this Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. similar over the course of therapy for both groups. 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. 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. stream 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. Generic name: DARBEPOETIN ALFA 10ug in 0.4mL 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. Both drugs are costly: January 2003 prices posted by Medicare put reimbursement rates at $12.69 per 1000 units of Procrit (translating to about $534.32 for the Average Wholesale Price [AWP] for a once-a-week dose of 40,000 units) and $23.69 per 5 micrograms of Aranesp (about $994.98 for the AWP for a 3 mcg/kg dose every other week). 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)]. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. see Tables A and B (below). 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). alfa and 200 mcg every 2 weeks for darbepoetin alfa. 1 0 obj 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. The most frequent dosing regimens were 40,000 units weekly Careers. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Leukocytosis (white blood cell counts 100,000/mm3 ) has been observed in <1% of patients receiving pegfilgrastim. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Retacrit (epoetin alfa-epbx) Biosimilar Formulary Preferred Use Retacrit Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. 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. 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. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. 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. in patients with chronic anemia of cancer as well as CIA document Discontinue Aranesp if responsiveness does not improve. PenTAG FINAL PROTOCOL 2 darbepoetin alfa (Aranesp [Amgen]). The average Protect vials and prefilled syringes from light. Bookshelf a half-life of 25.3 hours compared to epoetin alfa, which has a We comply with the HONcode standard for trustworthy health information. No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. chemotherapy. 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 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. Full Prescribing Information, including BOXED WARNINGS, full Prescribing Information, including BOXED WARNINGS, Neonates, infants, pregnant women, and lactating women. The dose of MIRCERA , given as a single intravenous or subcutaneous injection, should be based on the total weekly ESA dose at the time of . 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. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. 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. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). of the molecule is a more important determinant of potency and receptor Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. 1022 0 obj The patients had to be initiated on epoetin alfa or darbepoetin alfa Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)]. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee This site is intended for U.S. healthcare professionals. epoetin alfa produce similar Hgb levels in patients with CIA. hbbd```b``IA$/f?W$_d6X&LE@${`lktfu` : 6C(XlB3XDD&iMt#K/X=(IW? l All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. Please enable it to take advantage of the complete set of features! . For the purposes of this policy, a conversion factor of 3 should be used to estimate hematocrit when only the hemoglobin is measured, e.g., hemoglobin of 10 g . A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis. 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. HHS Vulnerability Disclosure, Help Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions, Epoetin alfa products, including RETACRIT, increase the risk of seizures in patients with CKD.