Lapatinib (Tykerb) Linked to Risk for Interstitial Lung Disease and Pneumonitis
On August 20, the FDA approved safety labeling revisions for lapatinib (Tykerb tablets; GlaxoSmithKline) to warn of the risk for interstitial lung disease and pneumonitis when used alone or in combination with other chemotherapies.
Interstitial lung disease refers to a group of lung conditions affecting the alveolar epithelium, pulmonary capillary endothelium, basement membrane, and perivascular and perilymphatic tissues.
Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease and pneumonitis. Discontinuation of therapy is indicated for those with severe symptoms (? grade 3, as evaluated with use of the National Cancer Institute's Common Technology Criteria for Adverse Events).
Lapatinib is indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress the human epidermal growth factor receptor 2 and who have received previous therapy including an anthracycline, a taxane, and trastuzumab.
http://www.fda.gov/medwatch/safety/2..._quickview.htm
http://www.fda.gov/medwatch/safety/2.../Tykerb_PI.pdf