The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%- 49%), and rash and related terms (36%-47%). ** +
Supportive care may help management of some mild-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.
Gleevec tablets should be taken with food and a large glass of water to minimize GI irritation. Gleevec tablets should not be taken with grapefruit juice and other foods known to inhibit CYP3A4.
Patients should be informed to take Gleevec exactly as prescribed, not to change their dose or stop taking Gleevec unless they are told to do so by their doctor. If patients miss a dose, they should be advised to take their dose as soon as possible unless it is almost time for their next dose, in which case the missed dose should not be taken. A double dose should not be taken to make up for any missed dose.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "should," "can," "expected,"
"may" or similar expressions, or by express or implied discussions
regarding potential regulatory approvals, new indications or labeling for,
or potential future sales of, Gleevec or Tasigna. Such forward-looking
statements reflect the current views of Novartis regarding future events,
and involve known and unknown risks, uncertainties and other factors that
may cause actual results with Gleevec or Tasigna to be materially different
from any future results, performance or achievements expressed or imp
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