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PDF Aranesp, Epogen, Mircera, Procrit, Retacrit - Cigna The site is secure.
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or . response rates ranging from ~60% to 85%. Do not mix with other drug solutions. !SSe@}vd^W7y% Qf={kGNyHD{9y`S [E^`G,PmN+`R)7oR'=. dbc&@hlv}t``t_/d+)X
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DY%--V! 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). Existing patients on IV EPO, change to subcutaneous EPO using the . _____ (if . in patients with chronic anemia of cancer as well as CIA document
Colony Stimulating Factors - GlobalRPH Darbepoetin alfa (5 N-linked
OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Overall, in
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 3 0 obj
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 as well). 33 Dose. The number
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. Overall, in both groups iron studies were not conducted routinely. At the June 2004 meeting, the CCF Pharmacy and Therapeutics Committee
The effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. Select one or more newsletters to continue. scMJkP`@SzQ`
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startxref 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). 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. Monitoring Parameters Complete blood count and platelet count should be obtained prior to chemotherapy. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Aranesp is administered less frequently than epoetin alfa. 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. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA approves first epoetin alfa biosimilar for the treatment of anemia, FDA: Office of Hematology and Oncology Products. 1 0 obj
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st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law. 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g.febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. : RaPL6!0 )KQml)D$ xCdmuJNI&"zS4j#INdh %PDF-1.6
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Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. 2006 Jan;40(1):58-65; quiz 169-70. doi: 10.1345/aph.1G042. of darbepoetin alfa, the half-life is ~49 hours (a similar half-life
hb```b``f`e`K`d@ A6 a8v3Vq=$%xCyczV?WVM, s..G6Oeedis4,!p$Y05P4 i@9W.C n. eCollection 2017. of darbepoetin administered SC has been shown in cancer patients
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conversion factor of 1 mcg:220 units Aranesp:EPO.
Pharmacotherapy Update - Automatic Therapeutic Interchange Program Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc) before initiating RETACRIT. Mean baseline Hgb levels
More specifically, 23 patients in the epoetin alfa group
Do not increase the dose more frequently than once every 4 weeks. 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. Evaluate response every 4-8 weeks thereafter and adjust the dose accordingly by 50-100 units/kg increments 3 times/week. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Epoetin alfa versus darbepoetin alfa in chemotherapy-related anemia. Do not dilute Aranesp and do not administer in conjunction with other drug solutions.
Switch from epoetin to darbepoetin alfa in hemodialysis: dose official website and that any information you provide is encrypted Previous dosage of epoetin alfa: 5000-10,999 units/week,then darbepoetin alfa dosage: 25 mcg/week. Accessibility In the near future, the Pharmacy and Therapeutics
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%. contracts, darbepoetin alfa is less expensive than epoetin alfa. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). Do not re-enter vial. k22atr
!h~h[={;X)Sr;:2{+S&x~tlgth6_'N'F?%2 @obXCC Key: Hgb = hemoglobin level, measured in . Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . endobj
Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. For recommended dose equivalency,
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Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. This site complies with the HONcode standard for trust- worthy health information: verify here. 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. stream
2009 Oct;2(5):347-53. doi: 10.1093/ndtplus/sfp097.
Aranesp (darbepoetin alfa) | Dosing Considerations If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusions.
Study of Transplant Related Anemia Treated With Aranesp (STRATA Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. In order to be included in the DUE,
Keep the tip of the needle in the RETACRIT liquid. Discard unused portion of Aranesp in vials or prefilled syringes. The assessment will also assess whether the reviewed drugs are likely to be considered good value for money for the NHS. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The original dosage reduction after the switch from epoetin alfa to weekly intravenous darbepoetin alfa may offset the increased relative cost of the latter.
ARANESP (darbepoetin alfa) Co-pay Card and Cost Assistance transfusions, and iron studies. Learn how to combine multiple dosing options for precise titration and individualize anemia management. 500 mcg every 3 weeks subcutaneously until completion of a chemotherapy course. 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).
PDF All Orders Must Be Marked in Ink With a Checkmark to Be Active. - Ohsu Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 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. 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. Table 1. alfa (Aranesp; Amgen) to be therapeutic equivalent products
Neumega is not indicated following myeloablative chemotherapy (see package insert for WARNINGS, Increased Toxicity Following Myeloablative Therapy). Protect vials and prefilled syringes from light. Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. *For pediatric patients receiving a weekly epoetin alfa dose of < 1,500 Units/week, the available data are insufficient to determine an Aranesp conversion dose. Inadequate response: Hemoglobin increases <1 g/dL over 4 weeks and iron stores are adequate: Increase by ~25% of the previous dose; increases should not be made more frequently than once monthly. . of Pharmacy Drug Information Center (216-444-6456, option #1). The dose should be titrated to meet and
All orders for epoetin alfa-epbx (RETACRIT) will be converted to darbepoetin alfa using equivalent therapeutic interchange dosing listed in the table below. 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. epoetin theta (Eporatio [Teva UK]), epoetin zeta (Retacrit [Hospira UK]), and . This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. The optimal timing and duration of growth factor stimulation has not been determined. 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). Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week.
Aranesp | European Medicines Agency (CKD) patients, darbepoetin alfa administered intravenously has
Coverage Limitations Treatment with Darbepoetin alfa (Aranesp), Epoetin alfa (Procrit), Epoetin alfa (Epogen), and Epoetin alfa-epbx (Retacrit) is not considered medically necessary for members with the following concomitant conditions: Epub 2016 Mar 4. Scroll left to view table. If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. for the erythropoietin receptors, suggesting the slower clearance
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. Bookshelf 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. Clipboard, Search History, and several other advanced features are temporarily unavailable.
Aranesp Dosage Guide - Drugs.com alfa for chronic anemia of cancer and chemotherapy-induced anemia
endstream OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life. <> Slowly push the plunger up to force the air bubbles out of the syringe. 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). July/August 2004, Return to
Copyright 1993-2021 Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. These adverse reactions included myocardial infarction and stroke, In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures, ESAs resulted in decreased locoregional control/progression-free survival (PFS) and/or overall survival (OS). Can J Kidney Health Dis. If there are still air bubbles, repeat the steps above to remove them. Federal government websites often end in .gov or .mil. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. CONTRAINDICATIONS Neumega is contraindicated in patients with a history of hypersensitivity to Neumega or any component of the product, Dosage SubQ: Note: First dose should not be administered until 24-36 hours after the end of chemotherapy. 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. 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. <>/Filter/FlateDecode/ID[<6A376E50FA41294D8BDE0DC442E05AF8>]/Index[1022 100]/Info 1021 0 R/Length 147/Prev 333934/Root 1023 0 R/Size 1122/Type/XRef/W[1 3 1]>>stream
Pussell BA, Walker R; Australian Renal Anaemia Group. therapy. 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. Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg.
Switching from Epoetin Alfa (Epogen) to Epoetin Alfa-Epbx - PubMed Immediately and permanently discontinue RETACRIT and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs, Blistering and skin exfoliation reactions, including erythema multiforme and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported in patients treated with ESAs (including epoetin alfa) in the postmarketing setting. Careers. RETACRIT (epoetin alfa-epbx) is biosimilar* to EPOGEN/PROCRIT (epoetin alfa) WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE . In patients receiving treatment for cancer and whose anemia is not due to CKD. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. In recent years, the trend has been to use higher doses of epoetin alfa (eg, 60,000 U once per week), recognizing that MDS RBC precursors may have relative intrinsic resistance to EPO. were 9.95 g/dL and 9.80 g/dL in the epoetin alfa- and darbepoetin
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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. CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins pegfilgrastim Filgrastim, or any other component of the product. government site. RETACRIT safely and effectively. 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 epoetin alfa and darbepoetin alfa, have been shown to decrease the
alfa and 200 mcg every 2 weeks for darbepoetin alfa. The gasping syndrome is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. 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. 1022 0 obj affinity has no or little clinical relevance. chemotherapy. Splenic Rupture RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA. Like Epogen/Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about an increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. Correction of anemia associated with cancer patients receiving chemotherapy: Initial: 2.25 mcg/kg SQ once weekly. If hemoglobin continues to increase, hold dose temporarily until hemoglobin begins to decrease, then restart at a dose 25% below the previous dose. Please review the latest applicable package insert for additional information and possible updates. The
or 100 mcg SC once weekly. HrsW-D/tCPs. When switched from the reference epoetin, the majority of subjects (61.8 %) received another patented epoetin and 38.2 % received a biosimilar epoetin. 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 . Chronic Kidney Disease: 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. endobj
What is the difference between Retacrit and Procrit? - Drugs.com PDF Erythropoiesis-Stimulating Agents - Commercial Medical Benefit Drug Policy 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).
PDF Home Dialysis Programs Standing Orders - Erythropoietin of the molecule is a more important determinant of potency and receptor
In pediatric patients, Mircera is administered by intravenous injection only (2.2). Use caution in patients with coexistent cardiovascular disease and stroke. VII, No. HHS Vulnerability Disclosure, Help %PDF-1.6
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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)]. WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. 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. \v0!(?kX }y}3Q6bj>CMOaf&Uhzttxr"m- q! David McAuley, Pharm.D. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. A total of
MeSH What is/was your patient's PRETREATMENT hemoglobin level (g/dL) [prior to use of epoetin (Aranesp, Epogen, Mircera, Procrit, Retacrit)]? 4 0 obj
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Pharmacotherapy
Background: 4y\@:hT4\j
EvZ%fN1gtL|;`,% \ZPrC|.CtI8K,f^f#.PJ#|CZx~igq\jA@PPq. Vol. 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.
Safety and Efficacy: Currently available data indicate that darbepoetin
Methods: dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
Cases A, Portols J, Calls J, Martinez-Castelao A, Munar MA, Segarra A. Int Urol Nephrol.
PDF Biosimilar and Reference Products Conversion List for Adults - FormWeb Epub 2014 Aug 14. The .gov means its official.
PDF Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx similar over the course of therapy for both groups. half-life of 8.5 hours. Dosing: Dosing, even in morbidly obese patients, should be based on actual body weight. 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.