Tyverb®
Active ingredient: Lapatinib
Marketing authorisation holder: Glaxo Group Ltd
Availability: Private Sector
Variations: The conditional marketing authorisation of Tyverb® was renewed as its benefit-risk assessment
remained positive.
An open-label, single sequence study was carried out to evaluate the effect of elevated pH brought by
esomeprazole (a proton-pump inhibitor) on the relative bioavailability of lapatinib in patients with metastatic
ErbB2 positive breast cancer. When patients were pre-treated with esomeprazole, lapatinib exposure declined by
about 27% (range: 6% to 49%). Such effect may be minimised with increasing age (40 to 60 years). Drugs that
elevate pH must not be administered concomitantly since lapatinib solubility and absorption may be decreased.
Reference: European Medicines Agency. Tyverb. [online]. 2011 Aug 9 [cited 2011 Aug 23]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000795/human_med_001120.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124