aranesp to retacrit conversion

After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL, 300 Units/kg 3 times per week in adults or, 900 Units/kg (maximum 60,000 Units) weekly in pediatric patients. b. alfa may be administered as frequently as once every 3 or 4 weeks. Evaluate the iron status in all patients before and during treatment. 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). 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. <> Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Epoetin alfa. PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb The most frequent dosing regimens were 40,000 units weekly 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. Excessive response: Hemoglobin increases >1 g/dL in any 2-week period: Decrease dose Hemoglobin increases and approaches the target value of 12 g/dL: Decrease weekly dosage by ~25%. Like Epogen/Procrit, Retacrit must be dispensed with a patient Medication Guide that provides information about the drugs uses and risks. for epoetin alfa-treated patients and 200 mcg every 2 weeks (or Epogen is used in the dialysis area at CCF. Based on the patient's response, darbepoetin alfa may be administered as frequently as once every 3 or 4 weeks. A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks, In controlled clinical trials of patients with cancer, epoetin alfa increased the risks for death and serious adverse cardiovascular reactions. The FDA granted approval of Retacrit to Hospira Inc., a Pfizer company. The initial conversion factor of 210 units/microg rose to 275 units/microg (P = 0.01) at month 4. Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly. Aranesp Dosage Guide - Drugs.com Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis, Adverse reactions in 5% of epoetin alfa-treated patients on dialysis were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension, Adverse reactions in 5% of epoetin alfa-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation. The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. The implementation date for the interchange program is October 11, 2004. 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 . Protect vials and prefilled syringes from light. EPOETIN ALFA-EPBX, BIOSIMILAR, (RETACRIT) (FOR NON-ESRD USE), 1000 . An official website of the United States government. Epoetin timeline: 2/2020: Switched from Procrit to Retacrit preferred. 7. Based on market share 3 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. OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. Epub 2014 Aug 14. doses. Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms. However, this may result in the over treatment of uraemic anaemia. RETACRIT (epoetin alfa-epbx) Dosing Info | Safety Info - Pfizer pro Avoid frequent dose adjustments. Slowly push the plunger up to force the air bubbles out of the syringe. 1. RETACRIT Instructions For Use (epoetin alfa-epbx) No significant clinical decisions should be made based on these images from this website without first consulting with a board-certified attending physician. JKn&,&LzN Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. _ p8"&JjyfEMeRid=D fGKD 8qwR^{c`KNp% Kvu%Q rH]Y "[/|O"1S|FVA@-G%#&DOks]Qf/YQj*$K) Pharmacotherapy epoetin alfa and darbepoetin alfa for the management of CIA. These are recommended The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. <>stream %PDF-1.6 % adjustments may be required. If patient does not respond, a response to higher doses is unlikely. Conversion - Epoetin alfa (Procrit) to Darbepoetin | GrepMed endstream endobj 336 0 obj <>stream eCollection 2017. Initial U.S. Approval: 2018 . If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r SN:]AW&g{auwi(D)Si'(EK 9P$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 No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks. as well). of Pharmacy Drug Information Center (216-444-6456, option #1). The dose should be titrated to meet and Nephrology (Carlton). Providers who prefer to use epoetin alfa-epbx must specify a reason for its use. 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. 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. 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. 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. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee 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. Contributed by. Pussell BA, Walker R; Australian Renal Anaemia Group. Do not increase the dose more frequently than once every 4 weeks. interchange, such as patients with chronic renal failure (CRF). RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . Vol. Conversion of IV to SC EPO: a. A total of RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 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. During the first several months following initiation of RETACRIT, monitor patients closely for premonitory neurologic symptoms. RETACRIT single-dose vials contain phenylalanine, a component of aspartame. 4 0 obj 33 Dose. 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. 4y\@:hT4\j EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. Decreases in dose can occur more frequently. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. alfa and 200 mcg every 2 weeks for darbepoetin alfa. 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy ZARXIO is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)]. In pediatric patients, Mircera is administered by intravenous injection only (2.2). Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. The 335 0 obj <>stream When administered weekly and intravenously, darbepoetin alfa maintains Hb at a more favourable conversion rate than is currently recommended. Contraindication to Retacrit that is not a contraindication to Aranesp, or c. Side effect to Retacrit that would not be expected with Aranesp, or d. Patient has a religious belief objecting to treatment with a drug containing human . The products discussed in this site may have different product labeling in different countries. Preclinical trials have shown that mature megakaryocytes which develop during in vivo treatment with Neumega are ultrastructurally normal. Scroll left to view table. 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. Mechanism of Action: Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation differentiation commitment and some end-cell functional activation. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Refer to Aranesp package insert for pediatric dosing conversion. 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. The Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. PDF Highlights of Prescribing Information ----------------------- Dosage Overall, in 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. If severe anemia and low reticulocyte count develop during treatment with RETACRIT, withhold RETACRIT and evaluate patients for neutralizing antibodies to erythropoietin. Redox Rep. 2016 Jan;21(1):14-23. doi: 10.1179/1351000215Y.0000000022. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. RETACRIT (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Can J Kidney Health Dis. 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). RETACRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in: For additional details on storage and handling. Anemia Hard Choices: Comparing Procrit vs Aranesp : Oncology Times - LWW alfa (Aranesp; Amgen) to be therapeutic equivalent products Previous dosage of epoetin alfa: 34,000-89,999 units/week,then darbepoetin alfa dosage: 100 mcg/week. This site is intended for U.S. healthcare professionals. *Z?PkIV/X8$yN7.7 A brochure to help you understand how to dose and administer Aranesp, and to convert from epoetin alfa to Aranesp in patients with anemia due to CKD. 4 x previous weekly darbepoetin alfa dose (mcg)/0.55. Aranesp Dosing and Conversion Brochure. 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. 7/2021: added Epogen (nonformulary). Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) RETACRIT Dosage Forms and Strengths (epoetin alfa-epbx) 3 DOSAGE FORMS AND STRENGTHS Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of RETACRIT as a clear and colorless liquid in single-dose vials. !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! 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. government site. 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. In the near future, the Pharmacy and Therapeutics 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. affinity has no or little clinical relevance. In addition, at this time, this interchange program does not affect Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. x]Y8~w&*qq8g91YJUjUr2$u UuKf"3e&U+Wq&0Y No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Amgen 4 x previous weekly epoetin alfa dose (Units)/125. Results: Retacrit has been approved as a biosimilar, not as an interchangeable product. Do not dilute. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with epoetin alfa products. All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. erythropoietin, darbepoetin alfa stimulates erythropoiesis. Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). Biosimilar and Reference Products Conversion List for Adults (updated September 2022) Medication Reference Drug or Biosimilar . active than epoetin alfa, paradoxically was found to have less affinity Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. Patient Name_____ NKC#_____ Revised 01/14/2016 Page 1 of 4. Aranesp Dosing and Conversion Brochure | Amgen Anemia Hub IV Round the dose to the nearest treatment tier. 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). Clipboard, Search History, and several other advanced features are temporarily unavailable. VII, No. PDF Food and Drug Administration startxref This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; Wien Med Wochenschr. 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< Serious allergic reactions to OMONTYS. <>>> FOIA Additional warnings include high blood pressure, seizures, a condition in which the bone marrow stops making red blood cells thus causing anemia, serious allergic reactions and severe skin reactions. 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). Aranesp is administered less frequently than epoetin alfa. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase Evaluate other causes of anemia. before initiating Aranesp. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) Dosage form: injection, solution July/August 2004, Return to Neutropenic patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. Discontinue the drug at least 48 hours before beginning the next cycle of chemotherapy. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Platelets produced in response to Neumega were morphologically and functionally normal and possessed a normal life span. this interchange program should be directed to the CCF Department 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. May 15, 2018. Dosing & Product Information RETACRIT (epoetin alfa-epbx) has an identical dosing and administration schedule to Epogen/Procrit (epoetin alfa) 1. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). 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. epoetin alfa produce similar Hgb levels in patients with CIA. Do not dilute Aranesp and do not administer in conjunction with other drug solutions. %PDF-1.5 In addition, as with Epogen/Procrit, Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke and tumor growth or recurrence. alfa-treated patients, respectively. PDF Policy Title: Erythropoiesis stimulating agents: Retacrit (epoetin alfa In addition, Hgb levels were 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. e.g., 4 x 20 mcg of darbepoetin alfa per week/0.55 = 145.5 mcg of Mircera once every 4 weeks. The recommended starting dose is 0.45 mcg/kg body weight intravenously or subcutaneously given once at four week intervals as appropriate. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. 2 0 obj 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. 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 number Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. Would you like email updates of new search results? Cancer patients on chemotherapy (Treatment of patients with erythropoietin levels >200 mU/mL is not recommended). Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. k22atr !h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta Last updated on Jan 20, 2023.