Label Changes for:

Sutent (Sunitinib Malate) Capsules

August 2013

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

August 2013

 

WARNINGS AND PRECAUTIONS

  • Thyroid Dysfunction - Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of Sutent treatment.
 
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