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Chemotherapy

Amgen Announces Update To U.S. Prescribing Information for Aranesp and EPOGEN

Published in Blood Weekly, March 29th, 2007

Shortened overall survival and increased deaths attributed to disease progression at four months in patients with metastatic breast cancer receiving chemotherapy.

Cardiovascular events and tumor progression have been moved to the "Warnings" section from the "Precautions" section of all ESA labels.

The new boxed warning also states that ESAs increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population. In addition, for patients receiving ESAs pre-operatively for reduction of allogeneic blood...

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