new FDA warnung re lung complications from Tykerb

[Lani]

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

[Lani]

please see FDA warning above

[hutchibk]

Thanks Lani - I just emailed my doc a minute ago to see what we need to do...

[pattyz]

Brenda,
I'd be interested in what your onc says...

xopattyz

[hutchibk]

He says it appears to be fairly uncommon, but is something to watch out for. We will monitor for a persistent cough and shortness of breath. I will ask him more details when I see him in a few weeks.