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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

or to initiating Tasigna and monitor periodically during therapy.

Hepatic impairment: Tasigna has not been investigated in patients with hepatic impairment. Caution is recommended in these patients and QT interval should be monitored closely.

Drug interactions: Avoid concomitant use of strong inhibitors or inducers of CYP3A4. If patients must be co-administered a strong CYP3A4 inhibitor, dose reduction should be considered and the QT interval should be monitored closely.

Food Effects: Food increases blood levels of Tasigna. Avoid food 2 hours before and 1 hour after a dose.

Since the capsules contain lactose, Tasigna is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption.

Pregnancy: Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking Tasigna.

Adverse reactions

In chronic-phase CML patients, the most commonly reported drug-related adverse reactions (>10%) were rash, pruritis, nausea, fatigue, headache, constipation, diarrhea and vomiting. The common serious drug-related adverse reactions were thrombocytopenia and neutropenia. In accelerated-phase CML patients, the most commonly reported drug-related adverse reactions (>10%) were rash, pruritus and constipation. The common serious drug-related adverse reactions were thrombocytopenia, neutropenia, pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage, elevated lipase and pyrexia.

Tasigna may need to be withheld and/or dose reduced for QT interval prolongation, myelosuppression, and certain non-hematologic laboratory abnormalities (e.g., Grade greater than or equal to 3 elevated serum lipase or amylase, bilirubin and hepatic transaminases) as well as for other non- hematologic toxicities. Therapy with Tasigna was discontinued for drug-related adverse reactions in 11% and 8% of chronic-phase and acc
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SOURCE Novartis
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