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Novartis highlights extensive data on numerous compounds at ASCO in multiple cancers, including Phase III studies in GIST and myelofibrosis
Date:5/31/2011

ia (Ph+ CML) in chronic phase. The effectiveness of Tasigna for this indication is based on major molecular response and cytogenetic response rates at 12 months. The study is ongoing and further data will be required to determine long-term outcome.

Tasigna® (nilotinib) 200 mg capsules is also approved in more than 90 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. The effectiveness of Tasigna for this indication is based on hematologic and cytogenetic response rates.

TASIGNA BOXED WARNING and Additional Important Safety InformationTASIGNA (nilotinib) prolongs the QT interval. Sudden deaths have been reported in patients receiving TASIGNA. TASIGNA should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Hypokalemia or hypomagnesemia must be corrected prior to TASIGNA administration and should be periodically monitored. Drugs known to prolong QT interval and strong CYP3A4 inhibitors should be avoided. Patients should avoid food 2 hours before and 1 hour after taking dose. A dose reduction is recommended in patients with hepatic impairment.

ECGs should be obtained to monitor the QTc at baseline, 7 days after initiation and periodically thereafter, as well as following any dose adjustments.

  • Treatment with TASIGNA can cause Grade 3/4 thrombocytopenia, neutropenia and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months and then monthly thereafter.

  • Caution is recommended in patients with a history of pancreatitis.

  • The use of TASIGNA may result in elevations in bilirubin, AST/ALT and alkaline phosphatase.

  • TASIGNA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia and hyponatremia (see Boxed WARNING).

  • The concomitant use of strong CYP3A4 inhibitors or anti-arrhythmic drugs (includ
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