WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS, AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease [see Warnings and Precautions (5.1)]
• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular
reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a
hemoglobin level of greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase
these risks.
• Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer [see Warnings and Precautions (5.2)]
• Mircera is not indicated and is not recommended for the treatment of anemia due to cancer
chemotherapy. A dose-ranging study of Mircera was terminated early because of more deaths among
patients receiving Mircera than another ESA.
• ESAs have shown 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 cancers.