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Food effects: Food increases blood levels of Tasigna. Patients should avoid food 2 hours before and 1 hour after taking 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 Tasigna is administered to a pregnant woman. Women should be advised not to become pregnant when taking Tasigna.
Adverse reactions
In chronic phase patients, the most commonly reported adverse reactions ( >10%) were rash (33%), pruritus (29%), nausea (31%), fatigue (28%), headache (31%), constipation (21%), diarrhea (22%), and vomiting (21%). The most common ( >10%) Grade 3/4 adverse reactions were thrombocytopenia (28%), neutropenia (28%), elevated lipase (15%), and hyperglycemia (11%). In accelerated phase patients, the most commonly reported adverse reactions ( >10%) were rash (28%), pruritus (20%), and constipation (18%). The most common ( >10%) Grade 3/4 adverse reactions were thrombocytopenia (37%), neutropenia (37%), anemia (23%), and elevated lipase (17%). Other serious adverse reactions included pneumonia, febrile neutropenia, leukopenia, intracranial hemorrhage, and pyrexia (Grade 3/4: 2%).
Dose adjustments or modifications: Tasigna may need to be temporarily
withheld and/or dose reduced for QT prolongation, hematological toxicities
that are not related to underlying leukemia, clinically significant
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| SOURCE Novartis Pharmaceuticals Corporation Copyright©2008 PR Newswire. All rights reserved |