Topic: Erlotinib Linked to Deaths in Patients With Hepatic Impairment...

Erlotinib Linked to Deaths in Patients With Hepatic Impairment, Advanced Solid Tumours

OTTAWA, Ontario -- December 17, 2008 -- Hoffmann-La Roche Limited, in consultation with Health Canada, is informing healthcare professionals of important new safety information regarding the use of erlotinib (Tarceva) in patients with moderate hepatic impairment and advanced solid tumours.

Based on review of a pharmacokinetic study in patients with advanced solid tumours comparing patients with moderate hepatic impairment (Child-Pugh Score 7-9) and those with normal hepatic function:

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