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Oncologic Drugs Advisory Committee (ODAC) Materials
March 13, 2008
Ortho Biotech
Food and Drug Administration
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PROCRIT (Epoetin alfa) Media Site
Press Releases:
Ortho Biotech Modifies Prescribing Information for PROCRIT® (Epoetin alfa)
Release Date: March 7, 2008
Ortho Biotech Modifies Prescribing Information for PROCRIT® (Epoetin alfa)
Release Date: November 8, 2007
ORTHO BIOTECH SUPPORTS FDA ADVISORY COMMITTEES' RECOMMENDATIONSON USE OF ESAs IN CHRONIC RENAL FAILURE PATIENTS
Release Date: September 11, 2007
Ortho Biotech Reiterates Confidence in PROCRIT® (Epoetin alfa) Safety and Efficacy When Used According to Label
Release Date: September 11, 2007
Ortho Biotech Revises Prescribing Information for PROCRIT® (Epoetin alfa)
Release Date: March 9, 2007
Other PROCRIT® Resources
Letter to Healthcare Professionals (March 2008)
Letter to Healthcare Professionals (November 2007)
Letter to Healthcare Professionals (March 2007)
Statement to Healthcare Professionals Concerning CMS Proposal for ESA Coverage
FDA Public Health Advisory
Patient Package Insert
Full Prescribing Information
Helpful Links:
FDA Office of Oncology Drug Products
American Society Clinical Oncology
American Society of Hematology
National Comprehensive Cancer Network
American Society of Nephrology
National Kidney Foundation
Johnson & Johnson
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 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.
(See WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events, WARNINGS: Increased Mortality and/or Tumor Progression, and DOSAGE AND ADMINISTRATION.)
Please see Full Prescribing Information, including Boxed WARNINGS for more details.
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