The FDA ( Food and Drug Administration ) is requiring all drugs called Erythropoiesis-Stimulating Agents ( ESAs ) to be prescribed and used under a risk management program, known as a risk evaluation and mitigation strategy ( REMS ), to ensure the safe use of these drugs. The ESAs that are part of the REMS are marketed under the names Epogen, Procrit, and Aranesp.
FDA required Amgen, the manufacturer of these products, to develop a risk management program because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products.
Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

ESAs work by stimulating the bone marrow to produce red blood cells. ESAs are approved for the treatment of anemia resulting from chronic kidney failure, chemotherapy, certain treatments for Human Immunodeficiency Virus ( HIV ), and also to reduce the number of blood transfusions during and after certain major surgeries.

As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. In addition to the Medication Guide, Amgen was required to develop the ESA APPRISE ( Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs ) Oncology program for healthcare professionals who prescribe ESAs to patients with cancer.

Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program.

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancer.
To decrease the risks of ESAs, the lowest dose needed should be used to avoid red blood cell transfusion.
ESAs should be discontinued following completion of a chemotherapy course of treatment.

Aranesp ( Darbepoetin alfa ) is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy, based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies.

Epogen / Procrit ( Epoetin alfa ) is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy, based on studies that have shown a reduction in the need for red blood cell transfusions in patients with metastatic, non-myeloid malignancies receiving chemotherapy for a minimum of 2 months.

ESAs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
ESA use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.

Source: FDA, 2010

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