Amgen and Centocor Ortho Biotech Products Finalize ESA Risk Evaluation and Mitigation Strategy (REMS) With FDA
--Medication Guide Available For All Indications
THOUSAND OAKS, Calif., Feb 16, 2010 /PRNewswire via COMTEX/ -- Amgen Inc. (Nasdaq: AMGN) and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp(R) (darbepoetin alfa), EPOGEN(R) (Epoetin alfa) and PROCRIT(R) (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.
As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. To ensure continued access to ESAs for healthcare providers who prescribe, or prescribe and dispense, ESAs to patients with cancer, providers are required to train and enroll in the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program and to document that a discussion about the risks of ESAs took place with each patient prior to the initiation of each new course of ESA therapy. The ESA APPRISE Oncology Program will be launched on March 24, 2010. Direct patient registration or approval prior to ESA administration is not required through the ESA APPRISE Oncology Program.
The goal of the ESA REMS is to support informed decisions between patients and their healthcare providers (HCPs) who are considering treatment with Aranesp, EPOGEN or PROCRIT educating them on the risks of ESAs. For treatment of patients with cancer, the goal of the REMS, as implemented through the ESA APPRISE Oncology Program, is to mitigate the risk of decreased survival and/or poorer tumor outcomes.
"The ESA REMS represents our continued commitment to patient education and safety," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "This program supports a thoughtful dialogue between healthcare providers and patients when considering ESA treatment."
To support the implementation of the ESA APPRISE Oncology Program, Amgen and Centocor Ortho Biotech Products will distribute a Dear Healthcare Provider letter introducing the program, providing the rationale, program objectives, training and enrollment requirements and consequences for non-enrollment. Beginning March 24, healthcare providers who prescribe, or prescribe and dispense ESAs for patients with cancer and hospitals that dispense ESAs for patients with cancer will be able to train and enroll in the ESA APPRISE Oncology Program by contacting their local Amgen or Centocor Ortho Biotech Products field representative or by accessing the ESA APPRISE Oncology Program Website, www.esa-apprise.com.
For information about the complete ESA APPRISE Oncology program, please visit http://wwwext.amgen.com/media/amgen_esa_risk_evaluation.html or http://www.centocororthobiotech.com/. For full prescribing information and medication guides, please visit http://www.aranesp.com/, http://www.epogen.com/, and http://www.procrit.com/.
IMPORTANT SAFETY INFORMATION
Aranesp is indicated for the treatment of anemia in patients with most types of cancer receiving chemotherapy as well as in patients with chronic renal failure (CRF), including patients on dialysis and patients not on dialysis.
EPOGEN is indicated for the treatment of anemia in patients with CRF on dialysis. EPOGEN is indicated to elevate or maintain the red blood cell (RBC) level and to decrease the need for transfusions in these patients.
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.
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Chronic Renal Failure:
- In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
- Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp, EPOGEN or PROCRIT to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit http://www.esa-apprise.com/ or call 1-866-284-8089 for further assistance.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: Epogen / Procrit increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
- ESAs are contraindicated in patients with uncontrolled hypertension.
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