TYVERB has been approved in more than 15 countries, and marketing applications for TYKERB/TYVERB have been filed around the world.
Important Safety Information*
As with other therapies for HER2 overexpression, Tykerb has been associated with reports of decreases in left ventricular ejection fraction (LVEF). Caution should be taken if Tykerb is to be administered to patients with pre-existing cardiac conditions, including uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. LVEF should be evaluated in all patients prior to and during treatment with Tykerb.
A dose reduction should be considered for patients with severe hepatic impairment.
Diarrhea was the most common adverse event resulting in discontinuation of study medication. Proactive management of diarrhea with anti-diarrheal agents is important, and severe cases of diarrhea may require administration of oral or intravenous electrolytes and fluids and interruption or discontinuation of therapy with Tykerb.
Tykerb has been associated with interstitial lung disease and pneumonitis. Discontinue Tykerb if patients experience severe pulmonary symptoms.*
Tykerb prolongs the QT interval in some patients. Consider ECG and electrolyte monitoring.
Fetal harm can occur when administered to a pregnant woman. Women should be advised not to become pregnant when taking Tykerb.
The most common adverse events (>20 percent) during treatment with Tykerb plus capecitabine were diarrhea, vomiting, nausea, fatigue, palmar-plantar erythrodysethesia, and rash.
*Please see full prescribing information.
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