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Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings


Data from five studies sponsored by Ortho Biotech Products, L.P. will be presented at the National Kidney Foundation (NKF) 2008 Spring Clinical Meetings from
April 2 – 6, 2008; three utilization studies involve PROCRIT® (Epoetin alfa).

The data include studies that compare drug utilization patterns and costs of PROCRIT® (EPO) and darbepoetin alfa (DARB), evaluate medical costs related to chronic kidney disease (CKD) patients with hypertension or diabetes, and show the impact on hemoglobin (Hb) control using a software-based management tool. These retrospective analyses used data from actual clinical practice.

Data on Drug Utilization Patterns and Costs of Epoetin Alfa and Darbepoetin Alfa

* Abstract: Assessment of Drug Utilization Patterns and Costs for Erythropoietic Stimulating Agents in Patients with Chronic Kidney Disease
Patrick Lefebvre, M.A., Groupe d’analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of medical claims was conducted using the Ingenix Impact National Managed Care Database to examine recent EPO and DARB treatment patterns and corresponding drug costs in newly-initiated CKD patients treated with EPO (n=1,110) or DARB (n=723) not receiving dialysis.bMean cumulative dose was used to calculate drug costs based on October 2007 wholesale acquisition unit prices.

* Abstract: Drug Utilization and Cost Considerations of Predialysis Chronic Kidney Disease Patients Receiving Erythropoietic Stimulating Agents Through Pharmacy Benefits
François Laliberté, M.A., Groupe d’analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of pharmacy claims using the PharMetrics Patient-Centric Database, which represents approximately 85 managed healthcare plans, was conducted to compare drug utilization patterns and costs of a newly-initiated, managed care predialysis chronic kidney disease population receiving EPO (n=1,066) or DARB (n=375) through a pharmacy benefit. Drug cost was based on cumulative dose and October 2007 wholesale acquisition cost.

Data on Medical Costs Related to Chronic Kidney Disease Patients with Hypertension or Diabetes

* Abstract: Medical Costs of Chronic Kidney Disease in Patients with Diabetes: A Managed Care Perspective
François Laliberté, M.A., Groupe d’analyse, Ltée, Montréal, Québec, Canada
A retrospective analysis of medical claims and laboratory data from a large managed care database was conducted to quantify the incremental direct healthcare costs of CKD in patients with diabetes. Analyses compared diabetes patients who developed CKD versus those who did not for yearly direct healthcare costs, which consisted of outpatient services, inpatient services and pharmacy dispensing claims. A total of 30,480 patients with diabetes were identified, of whom 859 developed CKD during the study period.

* Abstract: The Effect of Anemia in Hypertensive Patients with Chronic Kidney Disease: Hospital Costs and Length of Stay
Sandra Sulsky, M.P.H, Ph.D., ENVIRON International Corporation, Amherst, MA
A retrospective analysis of hospital discharge records from the 2004 Nationwide Inpatient Sample of the Hospital Cost and Utilization Project, which comprises approximately 90 percent of all hospital discharges in the U.S., was conducted to determine the effect of anemia on hospital costs and length of stay in hypertensive patients with CKD. Analyses were adjusted for age, gender, income level, severity of disease, and hospital characteristics to control for the confounding effects of anemia, CKD and a combination of both on study outcomes.

Data on the Impact on Hemoglobin Control Using a Software-Based Management Tool

* Abstract: Use of Epoetin Alfa in Maintaining Hemoglobin Control Through a Software-Based Management Tool in a Community Nephrology Setting
Craig Kleinmann, D.O., Nephrology Associates, Mobile, AL
A retrospective, observational chart review from a large U.S. nephrology clinic was conducted in May 2007 to analyze the impact of EPO on mean Hb over time as well as subsequent dose holds in anemic non-dialysis CKD patients in a community practice setting using TrakAnemia, a software-based tool. Eighty-seven patients who had a documented diagnosis of anemia due to non-dialysis CKD, initiated EPO, and had greater than or equal to six months of follow-up data were included in the final analysis.

About PROCRIT® (Epoetin alfa)

PROCRIT® is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT®


Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.


* ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of - 12 g/dL.
* The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to target a hemoglobin of - 12 g/dL.
* To minimize these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusions.
* Use only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
* Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT® increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.

PROCRIT® is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

Additional Important Safety Information

* The dose of PROCRIT should be titrated for each patient to achieve and maintain the following hemoglobin levels:
o Chronic renal failure patients – hemoglobin levels between 10 to 12 g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL despite 12 weeks of appropriate PROCRIT® therapy, see DOSAGE and ADMINISTRATION in the PROCRIT® Prescribing Information.
o Cancer or HIV patients – the lowest hemoglobin level sufficient to avoid transfusion and not to exceed 12 g/dL.
* Monitor hemoglobin regularly during therapy, more frequently following a dosage adjustment or until hemoglobin becomes stable.
* Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin have been reported in patients with chronic renal failure receiving PROCRIT® by subcutaneous administration. If any patient develops a sudden loss of response to PROCRIT® , accompanied by severe anemia and low reticulocyte count, and anti-erythropoietin antibody-associated anemia is suspected, withhold PROCRIT® and other erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or 1-888-227-5624) to perform assays for binding and neutralizing antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT® should be permanently discontinued and patients should not be switched to other erythropoietic proteins.
* The safety and efficacy of PROCRIT® therapy have not been established in patients with a known history of a seizure disorder or underlying hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes or hypercoagulable disorders).
* In some female patients, menses have resumed following PROCRIT® therapy; the possibility of pregnancy should be discussed and the need for contraception evaluated.
* Prior to and regularly during PROCRIT® therapy monitor iron status; transferrin saturation should be ³ 20% and ferritin should be ³ 100 ng/mL. During therapy absolute or functional iron deficiency may develop and all patients will eventually require supplemental iron to adequately support erythropoiesis stimulated by PROCRIT®.
* During PROCRIT® therapy, blood pressure should be monitored carefully and aggressively managed, particularly in patients with an underlying history of hypertension or cardiovascular disease.
* In studies, the most common side effects included fever (pyrexia), diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or loss of strength or weakness (asthenia, fatigue), shortness of breath, high blood pressure, headache, joint pain (arthralgias), abnormal skin sensations (as tingling or tickling or itching or burning; paresthesia), rash, constipation and upper respiratory infection.

Please visit for the full Prescribing Information, including the Boxed WARNINGS.


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