e.g., 4 x 1500 Units of epoetin alfa per week/125 = 48 mcg of Mircera once every 4 weeks. The dose conversion depicted in Table 1 does not accurately estimate the once monthly dose of Aranesp. of Pharmacy Drug Information Center (216-444-6456, option #1). alfa- and darbepoetin alfa-treated patients, respectively. in two ways: 1) Hgb levels > 12 g/dL or 2) an increase
Federal government websites often end in .gov or .mil. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Aranesp Dosing and Conversion Brochure. Sickle Cell Disease Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disease. In addition, at this time, this interchange program does not affect
Conclusion: Approved by FMOLHS P&T. . Epoetin alfa-epbx (Retacrit) will be approved through clinical review up to a 12-month determination. hemoglobin of > 12 g/dL was reached in 47 patients (41%)
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. contracts, darbepoetin alfa is less expensive than epoetin alfa. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis . 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 Background: The dose should be titrated to meet and
Discontinue treatment with oprelvekin >/= 2 days before starting the next planned cycle of chemotherapy. The optimal timing and duration of growth factor stimulation has not been determined. dvO*g%6u7Gw~A%a^7lW^{^6Vk?u^Gn"2@^n?0NS.OpJ
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The implementation date for the interchange program is October 11, 2004. Can J Kidney Health Dis. alfa and 200 mcg every 2 weeks for darbepoetin alfa. chemotherapy, MDS or MF, continued therapy) Please provide a hemoglobin level (g/dL) for your patient taken within the first 12 weeks of therapy with epoetin and include the date the lab was drawn. WARNINGS AND PRECAUTIONS Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: 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 benefits. Slowly push the plunger up to force the air bubbles out of the syringe. 114 (n=92 CCF) patients were included in the DUE, 59 epoetin alfa
epoetin alfa (3 N-linked CHO chains). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Note: The manufacturer states that, until efficacy/toxicity parameters are established, the use of oprelvekin in pediatric patients (particularly those <12 years of age) should be restricted to use in controlled clinical trials. 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 effect of pentoxifylline on oxidative stress in chronic kidney disease patients with erythropoiesis-stimulating agent hyporesponsiveness: Sub-study of the HERO trial. Decreases in dose can occur more frequently. Protect vials and prefilled syringes from light. endstream If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of Aranesp. The .gov means its official.Federal government websites often end in .gov or .mil. scMJkP`@SzQ`
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m7L\|oPC(Y^ K%!Tx#Cgp+P=g-nKgan9ae2UM{kH9z;j8rq!J@ ferrous sulfate, Procrit, Retacrit, epoetin alfa, Epogen, darbepoetin alfa. 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. FOIA 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). If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. <>
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. RETACRIT multiple-dose vials contain 8.5 mg of benzyl alcohol per mL. This site is intended for U.S. healthcare professionals. G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage. Evaluate the iron status in all patients before and during treatment. Based on data from this CCHS DUE, darbepoetin alfa and
Clipboard, Search History, and several other advanced features are temporarily unavailable. Aranesp is administered less frequently than epoetin alfa. Epub 2014 Aug 14. 2007 Aug;23(8):1931-7. doi: 10.1185/030079907X210705. RETACRIT safely and effectively. Questions regarding this interchange program should be directed to the CCF Department of Pharmacy Drug Information Center (216-444-6456, option #1). David McAuley, Pharm.D. 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. >/@tCh;6|{rf9V8&Wb~%l7JNCcoi AkrJ.ttbdq5QSu+r|0&OhF]{.r!r
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st3pYBMf7m\tHC6l#C(!%J[l6(d/$Apx>GW mo^6*{INX%!ZuH@=_c every-other-week) for darbepoetin alfa-treated patients. Do not mix with other drug solutions. 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. Darbepoetin alfa, although several fold more biologically
Last updated on Jan 20, 2023. Myelosuppressive therapy: 5 mcg/kg/day - doses may be increased by 5 mcg/kg according to the duration and severity of the neutropenia. Darbepoetin alfa. 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%. Depending upon each patient's needs and response, dosage adjustments may be required. 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 In order to be included in the DUE,
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. Refer to Aranesp package insert for pediatric dosing conversion. This site needs JavaScript to work properly. A local search option of this data can be found here. Previous dosage of epoetin alfa: 11,000-17,999 units/week,then darbepoetin alfa dosage: 40 mcg/week. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Supplied Injection, solution [preservative free]: 10 mg/mL (0.6 mL) [prefilled syringe]. Aranesp, Epogen, Procrit, and Retacrit are proven and medically necessary to treat anemia associated with myelodysplastic syndromes when the following criteria are met: 2, 3,8,9,32,46 . 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). Evaluation of Iron Stores and Nutritional Factors. government site. Previous dosage of epoetin alfa: 18,000-33,999 units/week,then darbepoetin alfa dosage: 60 mcg/week. In patients receiving treatment for cancer and whose anemia is not due to CKD. . 3 0 obj
Do not re-enter vial. Vol. 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. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breastfed milk, respectively. of patients receiving transfusions was similar between the groups,
Dosage form: injection, solution The recommended starting dose and schedules are: Self-Administration of the Prefilled Syringe. Stop dose if hemoglobin exceeds 13 g/dl and resume treatment at a 25% dose reduction when hemoglobin drops to 12 g/dl. most common dosing regimens are 40,000 units weekly for epoetin
When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. <>stream
Pronai W, Neyer U, Barnas U, Wieser C, Jaeger C, Dekic D, Hemetsberger M, Rosenkranz AR. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. Initial U.S. Approval: 2018 . for the erythropoietin receptors, suggesting the slower clearance
The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. 5,o_2&+PA1xRAag(sRVt?jN)r!ba,cKc$Z`6@5&ql~d:P /bc
yh{fM"fCCmF6TBxgE= Vue-#x4Bi8&ZC; administered less frequently. Check out recent approvals at the OCEs podcast, Drug Information Soundcast in Clinical Oncology. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAs MedWatch Reporting System or by calling 1-800-FDA-1088. 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. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation differentiation, and selected end-cell functions (including enhanced phagocytic ability priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and the increased expression of some cell surface antigens). Epub 2009 Aug 4. Key: Hgb = hemoglobin level, measured in . Nephrology (Carlton). 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. Careers. active than epoetin alfa, paradoxically was found to have less affinity
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. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Dosage adjustment: Goal: Dose should be adjusted to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. 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. 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. objective of the DUE was to trend usage patterns in the outpatient
The products discussed in this site may have different product labeling in different countries. for at least 3 weeks between July 2002 and July 2003. DOSAGE AND ADMINISTRATION Initial treatment: 0.04 mg/kg body weight administered once monthly. Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events (6.1). Refer to Table 1. response rates ranging from ~60% to 85%. There are independent nonprofit patient assistance programs that may be able to help patients afford the co-pay costs for their prescribed medicine. Bookshelf Mean baseline Hgb levels
Conclusion: In patients on hemodialysis receiving ESAs, conversion from epoetin alfa to darbepoetin alfa was associated with an approximate and persistent reduction of 65% of the required dose. Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis. Pull the plunger back to the number on the syringe that matches your dose. Conversion from another ESA: dose once monthly based on the total weekly epoetin or darbepoetin alfa dose at the time of conversion. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Estimated Aranesp Starting Doses (mcg/week) for Patients with CKD on Dialysis Based on Previous Epoetin alfa Dose (Units/week), Previous Weekly Epoetin alfa Dose (Units/week). 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. and approved an automatic therapeutic interchange to darbepoetin
Previous dosage of epoetin alfa: 90,000 units/week, then darbepoetin alfa dosage: 200 mcg/week. 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. The site is secure. Discard unused portion of Aranesp in vials or prefilled syringes. epoetin alfa and darbepoetin alfa for the management of CIA. General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies. similar over the course of therapy for both groups. 1121 0 obj These are recommended doses. HHS Vulnerability Disclosure, Help 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. CHO chains) has a 3-fold increase in half-life when compared to
Background: The recommended conversion dose for changing from epoetin alfa to darbepoetin alfa is 200 units to 1 microg. duration of therapy was 13.2 weeks and 13.6 weeks in the epoetin
0 Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 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. 2007 Apr;12(2):126-9. doi: 10.1111/j.1440-1797.2006.00762.x. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Children: 75-100 mcg/kg once daily for 10-21 days (until postnadir platelet count >/= 50,000 cells/ uL). AZT-treated, HIV infected patients: 100 units/kg IV/SC 3 times/week x 8 weeks. National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. However, this may result in the over treatment of uraemic anaemia. sharing sensitive information, make sure youre on a federal Unable to load your collection due to an error, Unable to load your delegates due to an error. See full prescribing information for RETACRIT. OHSU's formulary erythropoiesis stimulating agent (ESA) is darbepoetin alfa (ARANESP). Estimate the starting weekly dose of Aranesp for adults and pediatric patients on the basis of the weekly epoetin alfa dose at the time of substitution (see Table 1). Peripheral blood progenitor cell (PBPC) collection: 10 mcg/kg/day or 5-8 mcg/kg twice daily in donors. 4. Monitor platelets and hematocrit regularly. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Non-hematopoietic pathologic changes observed in animals include fibrosis of tendons and joint capsules, periosteal thickening, papilledema, and embryotoxicity. alfa-treated patients, respectively. -m]|;VB
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If patient does not respond, a response to higher doses is unlikely. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Aranesp. The approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity between Retacrit and U.S.-licensed Epogen/Procrit demonstrating that Retacrit is highly similar to US-licensed Epogen/Procrit and that there are no clinically meaningful differences between the products. 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. A single hemoglobin excursion may not require a dosing change. 2017 Jun 30;4:2054358117716461. doi: 10.1177/2054358117716461. The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned 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. 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. Supplied Injection, powder for reconstitution: 5 mg, INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 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. REASON FOR . Before sharing sensitive information, make sure you're on a federal government site. 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. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. Table 1. Evaluate the iron status in all patients before and during treatment. Check again for air bubbles. The
Note: In patients receiving epoetin alfa 2-3 times per week, darbepoetin alfa is administered once weekly. 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. Ms~hXb!X;i R9x9nt\z`g(!7E=Uf*U5 Methods: All in-centre haemodialysis patients (n = 60) were converted from an existing subcutaneous epoetin alfa regimen to weekly intravenous darbepoetin alfa. 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. official website and that any information you provide is encrypted Overall, in both groups iron studies were not conducted routinely. 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 . In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. U qjRO6nY>++xsR _:b*v fzMg918}jS\0^$ i~OG3!tRG`T(b>L&PeRj\L,F#f09w6aCN
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R5P-S&C>yxCDL{d^Nij:t5k!_ybecbXharWMmIAS|F7bmM+"qJz)!Yt!V\pz%6aE0oi4ciwy6d" A 30-day supply of Procrit costs well over $2,000 and prices for Epogen average around $600 per month. Bonafont X, Bock A, Carter D, Brunkhorst R, Carrera F, Iskedjian M, Molemans B, Dehmel B, Robbins S. NDT Plus. both groups iron studies were not conducted routinely. M(aOf}c^gw+&=s=O{+h5ACmVA;8*=vSO`8dmD}a"'3L
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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. 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. July/August 2004, Return to
dose of darbepoetin alfa for CIA is 200 mcg SC every-other-week
Hgb level. 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.
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