文档介绍：HIGHLIGHTS OF PRESCRIBING INFORMATION
strong CYP3A4 inhibitors. () Use with caution in patients with
These highlights do not include all the information needed to use Tasigna hepatic impairment (). Obtain ECGs at baseline, seven days after
safely and effectively. See full prescribing information for Tasigna. initiation, and periodically thereafter, as well as following any dose
Tasigna® (nilotinib) Capsules adjustments. (, , , )
• Sudden deaths: Sudden deaths have been reported in patients with
Initial . Approval: 2007 resistant or intolerant Ph+ CML receiving nilotinib. Ventricular
WARNING: QT PROLONGATION AND SUDDEN DEATHS repolarization abnormalities may have contributed to their occurrence.
• Elevated serum lipase: Check serum lipase periodically. In case lipase
See full prescribing information for complete boxed warning. elevations are accompanied by abdominal symptoms, interrupt doses and
Tasigna prolongs the QT interval (). Sudden deaths have been consider appropriate diagnostics to exclude pancreatitis. Caution is
reported in patients receiving nilotinib (). Tasigna should not be used recommended in patients with history of pancreatitis. ()
in patients with hypokalemia, hypomagnesemia, or long QT syndrome • Liver function abnormality: Tasigna may result in elevations in
(4). Hypokalemia or hypomagnesemia must be corrected prior to Tasigna bilirubin, AST/ALT, and alkaline phosphat