ALVOCEVA FILM-COATED TABLETS 100MG

TABLET, FILM COATED

**4.2 Posology and method of administration** Erlotinib treatment should be supervised by a physician experienced in the use of anti-cancer therapies. Posology **General** _Non-Small Cell Lung Cancer_ EGFR mutation testing should be performed prior to initiation of erlotinib as first-line or maintenance therapy in patients with locally advanced or metastatic NSCLC. The recommended daily dose of erlotinib is 150 mg taken at least one hour before or two hours after the ingestion of food. _Pancreatic cancer_ The recommended daily dose of erlotinib is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication). **Special Dosage Instructions** Drug Interactions: Concomitant use of CYP 3A4 substrates and modulators may require dose adjustment. _Hepatic impairment_ Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7–9) compared with patients with adequate hepatic function, caution should be used when administering erlotinib to patients with hepatic impairment. Dose reduction or interruption of erlotinib should be considered if severe adverse reactions occur. Safety and efficacy have not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Smokers: Cigarette smoking has been shown to reduce erlotinib exposure by 50–60%. The maximum tolerated dose of erlotinib in NSCLC patients who currently smoke cigarettes was 300 mg. The 300 mg dose did not show improved efficacy in second-line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes (see sections 4.5 and section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment_ The safety and efficacy of erlotinib has not been studied in patients with renal impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Based on pharmacokinetic data, no dose adjustments appear necessary in patients with mild or moderate renal impairment. Use of erlotinib in patients with severe renal impairment is not recommended. _Paediatric population_ The safety and efficacy of erlotinib, in the approved indications has not been established in patients under the age of 18 years. When dose adjustment is necessary, it is recommended to reduce in 50 mg steps (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Method of administration For oral use.