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Video and Photo: Tasigna(R) Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients With Resistance or Intolerance to Existing Therapies
Date:10/29/2007

QT interval. Sudden deaths have been reported in patients receiving Tasigna. Tasigna should not be used in patients with hypokalemia (low potassium levels), hypomagnesemia (low magnesium levels), or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to Tasigna administration and should be periodically monitored. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food two hours before and one hour after taking dose. Use with caution in patients with hepatic impairment. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

Warnings and precautions

Myelosuppression: Associated with neutropenia, thrombocytopenia and anemia. CBC should be done every 2 weeks for the first 2 months, then monthly. Reversible by withholding dose. Dose reduction may be required.

QT Prolongation: Tasigna prolongs the QT interval. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically. Avoid drugs known to prolong the QT interval and strong CYP3A4 inhibitors. Use caution in patients with hepatic impairment. Obtain ECGs at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

Sudden deaths: There were sudden deaths reported in the safety population and the expanded access program. Ventricular repolarization abnormalities may have contributed to their occurrence.

Elevated serum lipase: Caution is recommended in patients with history of pancreatitis. Check serum lipase periodically.

Liver function abnormality: Tasigna may result in elevations in bilirubin, AST/ALT, and alkaline phosphatase. Check hepatic function tests periodically.

Electrolyte abnormalities: Tasigna can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities pri
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