Cardiac toxicity: Lapatinib has been associated with reports of decreases in LVEF. Lapatinib has not been evaluated in patients with symptomatic cardiac failure. Caution should be taken if lapatinib is to be administered to patients with conditions that could impair left ventricular function (including co-administration with potentially cardiotoxic medicinal products). There has been no dedicated study to assess the potential for lapatinib to prolong the QT interval. A small, concentration dependent increase in QTc interval was observed in an uncontrolled, open-label dose escalation study of lapatinib in advanced cancer patients, such that an effect on QT interval cannot be ruled out.¹

Interstitial lung disease and pneumonitis: Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis.¹

Hepatotoxicity: Hepatotoxicity has occurred with lapatinib use and may in rare cases be fatal. The hepatotoxicity may occur days to several months after initiation of treatment. ¹

Diarrhoea: Diarrhoea, including severe diarrhoea, has been reported with lapatinib treatment. Diarrhoea can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances and fatal cases have been reported.¹

Detailed information on the use of lapatinib in combination with trastuzumab and its safety profile, including routine monitoring and other management requirements, are described in the Summary of Product Characteristics, which can be accessed on the EMA website, together with the European Public Assessment Report (http://www.ema.europa.eu) and in the Community Register of Medicinal Products on the European Commission’s website (http://ec.europa.eu/health/documents/community-register/html/index_en.htm).