Assessment of EGFR mutation status: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false-negative or
false-positive determinations. 
ILD/Pneumonitis: Severe and fatal ILD/pneumonitis occurred in patients treated with DACOPLICE^® and occurred in 0.5 % of the 394 DACOPLICE^®-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold DACOPLICE^® and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g. dyspnoea, cough and fever). Permanently discontinue DACOPLICE® if ILD is confirmed.
Diarrhoea: Severe and fatal diarrhoea occurred in patients treated with DACOPLICE^®. Diarrhoea occurred in 86% of the 394 DACOPLICE^®-treated patients; Grade 3 or 4 diarrhoea was reported in 11% of patients and 0.3% of cases were fatal. Withhold DACOPLICE^® for Grade 2 or greater diarrhoea until recovery to less than or equal to Grade 1 severity, then resume DACOPLICE^® at the same or a reduced dose depending on the severity of diarrhoea [see Sections 4.2. Posology and method of administration and 4.8. Clinical trial experience]. Promptly initiate anti-diarrhoeal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhoea.
Skin-related adverse reactions: Rash and exfoliative skin reactions occurred in patients treated with DACOPLICE^®. Rash occurred in 78% of the 394 DACOPLICE^®-treated patients; Grade 3 or 4 rash was reported in 21% of patients. Exfoliative skin reactions of any severity were reported in 7% of patients. Grade 3 or 4 exfoliative skin reactions were reported in 1.8% of patients. Withhold DACOPLICE^® for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse reaction until recovery to less than or equal to Grade 1 severity, then resume DACOPLICE^® at the same or a reduced dose depending on the severity of the dermatologic adverse reaction. Posology and method of administration and clinical trial experience]. The incidence and severity of rash and exfoliative skin reactions may increase with sun exposure. At the time of initiation of DACOPLICE^®, initiate use of moisturizers and appropriate measures to limit sun exposure. Upon development of Grade 1 rash, initiate treatment with topical antibiotics and topical steroids. Initiate oral antibiotics for Grade 2 or more severe dermatologic adverse reactions.
Embryo-foetal Toxicity: Based on findings from animal studies and its mechanism of action, DACOPLICE^® can cause foetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of dacomitinib to pregnant rats during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced foetal body weight at doses resulting in exposures near the exposure at the 45 mg human dose. The absence of EGFR sign align has been shown to result in embryo lethality as well as post-natal death in animals. Advise pregnant women of the potential risk to the foetus. Advise females of reproductive potential to use effective contraception during treatment with DACOPLICE^® and for at least 17 days after the final dose.