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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 [see Warnings and PRECAUTIONS].

Cancer: Mircera (methoxy polyethylene glycol-epoetin beta) is not indicated for the treatment of anemia due to cancer chemotherapy. A dose- ranging study of Mircera (methoxy polyethylene glycol-epoetin beta) was terminated early because of significantly more deaths among patients receiving Mircera (methoxy polyethylene glycol-epoetin beta) than another ESA. In other studies of ESAs in patients with 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 dose to a target hemoglobin of ≥ 12 g/dL.
• The risks of shortened survival and tumor promotion have not been excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL [see Warnings and PRECAUTIONS].