Procrit (Epoetin Alfa) Data to be Presented at American Society ofHematology Annual Meeting
ATLANTA, December 06, 2007 /PRNewswire/ -- Data from 11 PROCRIT(R) (Epoetin alfa) studies will be presented at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition December 8 - 11, 2007.
The data will provide important insights including: -- the potential impact on the nation's blood supply of limiting the use of erythropoiesis-stimulating agents (ESAs) for the treatment of chemotherapy-induced anemia (CIA); -- the use of PROCRIT in extended dosing regimens; -- the use of PROCRIT for treatment of transfusion-dependent anemia in patients with myelodysplastic syndromes (MDS); -- PROCRIT and real-world practice patterns; -- PROCRIT in managed care settings; and -- observational data from the Dosing Outcomes Study of Erythropoiesis- Stimulating Therapies (DOSE) Registry.
In some cases, the data are from investigational studies and do not reflect current U.S. Food and Drug Administration (FDA)-approved PROCRIT indications or recommended dosage and administration. Please note that all information presented at ASH is embargoed for media release until the data are made available to the public on the ASH Web site.
Data on the Potential Impact on Blood Supply of Limiting ESA Use for Chemotherapy Patients
-- Poster: Impact of Limiting Erythropoiesis-Stimulating Agent Use for Chemotherapy-Induced Anemia on the United States Blood Supply Francis Vekeman, M.A., Groupe d'analyse, Ltee, Montreal, Quebec, Canada Presentation: Monday, December 10, 2007; 5:00pm - 7:00pm; Hall B3 and B4 in the Georgia World Congress Center (Poster Board Number 115, Publication Number 2896) A modeling simulation was employed to estimate the impact of limiting the use of ESAs for CIA on the U.S. blood supply. The model used a top-down approach to compare the number of red blood cell units transfused in ESA-treated patients to the number of red blood cell units that would be transfused if ESAs were discontinued or limited in the same population. Data on PROCRIT Investigational Extended Dosing Regimens -- Abstract: Early vs. Standard Intervention With an Extended Epoetin alfa (EPO) Dose Regimen of 120,000 Units (U) Every 3 Weeks (Q3W) in Chemotherapy (CT)-Induced Anemia: Results for Elderly vs. Younger Patients in a Randomized Clinical Trial Veena Charu, M.D., Pacific Cancer Medical Center, Inc., Anaheim, CA Publication Number 3769 A retrospective subset analysis of a prospective, randomized, open- label, multi-center study compared key efficacy and safety results of elderly (n=62) and younger (n=73) patients with non-myeloid malignancy. Patients with chemotherapy planned for greater than or equal to 9 weeks and baseline hemoglobin greater than or equal to 11 and less than or equal to 12 grams per deciliter (g/dL) were randomized either to "early" intervention with Epoetin alfa or to "standard" intervention with Epoetin alfa when hemoglobin decreased to <11 g/dL. -- Abstract: Erythroid Response to Epoetin alfa (EPO) 120,000 Units (U) Every Three Weeks (Q3W) Initiated Early or at a Standard Threshold in Chemotherapy-Induced Anemia (CIA) Veena Charu, M.D., Pacific Cancer Medical Center, Inc., Anaheim, CA Publication Number 3770 A retrospective analysis of observed hematologic profiles from a 16- week, open-label, randomized study enrolled patients with non-myeloid malignancy, baseline hemoglobin greater than or equal to 11 and less than or equal to 12 g/dL, and chemotherapy planned for greater than or equal to 9 weeks to evaluate whether hemoglobin levels could be adequately maintained with Q3W Epoetin alfa initiation treatment. Patients were randomized according to study protocol to "early" or "standard" intervention groups (n=68 in each group). -- Abstract: Investigation of Epoetin alfa (EPO) 80,000 Units (U) Every 4 Weeks (Q4W) vs. 40,000 U Every 2 Weeks (Q2W) in Patients with Cancer Not Receiving Chemotherapy (CT) or Radiation Therapy (RT): Final Results Daniel Shasha, M.D., Beth Israel Medical Center, New York, NY Publication Number 3775 This prospective, randomized, open-label, multi-center pilot study with 100 patients with an active non-myeloid malignancy, baseline hemoglobin level less than or equal to 11 g/dL, and not receiving or planning to receive CT or RT during the course of the study, was designed to investigate two novel dosing regimens in this population. Based on recent safety concerns from studies with another ESA in cancer patients not receiving CT or RT, enrollment in this study was stopped prior to the planned enrollment.
Data on PROCRIT for the Investigational Treatment of Transfusion-Dependent Anemia in MDS Patients
-- Poster: Treatment of MDS Related Transfusion-Dependent Anemia With Epoetin alfa: A Meta-Analysis Perspective Suneel Mundle, Ph.D., Ortho Biotech Clinical Affairs, LLC, Bridgewater, NJ Presentation: Saturday, December 8, 2007; 5:30pm - 7:30pm; Hall B3 and B4 in the Georgia World Congress Center (Poster Board Number 625, Publication Number 1471) A meta-analysis of data extracted from studies found in PubMed, American Society of Clinical Oncology (ASCO) and ASH proceedings from 1990 to 2006 in transfusion-dependent MDS patients (n=578) treated with Epoetin alfa plus or minus granulocyte and granulocyte-macrophage colony stimulating factors (G/GM-CSF) assessed the efficacy of Epoetin alfa in achieving transfusion independence in transfusion-dependent MDS patients. -- Abstract: Drug Utilization and Cost Considerations of Erythropoiesis- Stimulating Agents in Patients with Myelodysplastic Syndromes Francois Laliberte, M.A., Groupe d'analyse, Ltee, Montreal, Quebec, Canada Publication Number 4611 A retrospective analysis of medical claims examined Epoetin alfa and darbepoetin alfa dosing patterns, ESA treatment costs and red blood cell transfusion use in order to characterize real-world utilization of ESAs in adult patients with MDS. -- Abstract: Assessment of Epoetin alfa in Patients with Myelodysplastic Syndrome Utilizing an Electronic Medical Record Database Bruce Feinberg, D.O., Georgia Cancer Center Oncology, Decatur, GA Publication Number 5180 A retrospective, observational study, using electronic medical record data from a large oncology/hematology practice in the southeastern United States, was conducted to gain a better understanding of the demographics, real-world treatment patterns and clinical outcomes for patients with MDS receiving Epoetin alfa. Data on PROCRIT and Real-World Practice Patterns -- Poster: Erythropoiesis-Stimulating Agents for Chemotherapy Induced Anemia: Analysis of an Electronic Medical Record Database within a Large Oncology/Hematology Practice Bruce Feinberg, D.O., Georgia Cancer Center Oncology, Decatur, GA Presentation: Saturday, December 8, 2007; 5:30pm - 7:30pm, Hall B3 and B4 in the Georgia World Congress Center (Poster Board Number 117, Publication Number 963) A retrospective, observational study using electronic medical record data from a large oncology/hematology practice in the southeastern United States was conducted to gain a better understanding of real- world treatment patterns and clinical outcomes in patients with cancer receiving chemotherapy and ESA therapy. Data on PROCRIT in Managed Care Settings -- Abstract: Drug Utilization Patterns and Cost Considerations for Erythropoiesis Stimulating Agents in Cancer Chemotherapy Patients in a Managed Care Setting Alyson Mandel, Ph.D., Medical Practice Data Corporation, Claverack, NY Publication Number 5157 A retrospective, observational analysis of ESA utilization in more than 4,100 chemotherapy patients using adjudicated medical claims between 2004 and 2006 from seven health plans was conducted to understand current utilization patterns. The study examined real-world dosing and drug costs for ESAs (Epoetin alfa and darbepoetin alfa) in cancer patients receiving chemotherapy. -- Abstract: Medical Visit Patterns in Cancer Chemotherapy Patients Receiving Erythropoiesis Stimulating Agents in a Managed Care Setting Alyson Mandel, Ph.D., Medical Practice Data Corporation, Claverack, NY Publication Number 5156 A retrospective analysis of medical claims between January 2004 and December 2005 using the Integrated Health Care Information Systems national database and representing more than 35 health plans was conducted to describe visit patterns and identify the proportion of medical visits made exclusively for ESA treatment in cancer chemotherapy patients. Observational Data from the DOSE Registry -- Abstract: Hemoglobin Levels Prior To Blood Transfusions In Oncology Patients Receiving Chemotherapy and Erythropoiesis-Stimulating Agents (ESAs): Observational Data from the DOSE Registry Kay Larholt, Sc.D., Abt Associates, Lexington, MA Publication Number 4019 A retrospective analysis of real-world data from ESA-treated oncology patients obtained from an ongoing prospective, observational registry, Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE), to characterize hemoglobin levels or transfusion triggers. Data were collected from participating hospital- and community-based outpatient practices between December 2003 and July 2007.
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
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR AND THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
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.
Cancer: -- ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with advanced breast, head and neck, lymphoid, and non-small cell lung malignancies when dosed to target a hemoglobin of greater than or equal to 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: -- 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. -- 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 greater than or equal to 20% and ferritin should be greater than or equal to 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 www.procrit.com for the full Prescribing Information, including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.
CONTACT: Stephanie Fagan, for Ortho Biotech, +1-908-541-4029, or cell,+1-201-572-9581, firstname.lastname@example.org
Web site: http://www.orthobiotech.com/
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Posted: December 2007