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Hepatotoxicity: Asymptomatic increases in liver transaminases have been observed in Erlotinib treated patients; therefore, periodic liver function testing (transaminases, bilirubin, and alkaline phosphate) should be considered.
Patients with Hepatic Impairment: In vitro and in vivo evidence suggest that erlotinib is cleared primarily by the liver.
Therefore, erlotinib exposures may be increased in patients with hepatic dysfunction.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Erlotinib has been tested for genotoxicity in a series of in vitro assays (bacterial mutation, human lymphocyte chromosome aberration, ad mammalian cell mutation) and in vivo mouse bone marrow micronucleus test and did not cause genetic damage. Erlotinib did not impair fertility in either male or female rats.
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