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 erlotinib |
| Tarceva |
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Pharmaceutical
company:
OSI Pharmaceuticals
www.osip.com |
NEW WARNING
OSI Pharmaceuticals and Genentech have issued a "Dear Health Care Professional" letter about updates to prescribing information for their epidermal growth factor receptor inhibitor, erlotinib (Tarceva). The new prescribing information warns that GI perforation (including fatalities); bullous, blistering, and exfoliative skin conditions; and ocular disorders, including corneal perforation or ulceration, abnormal eyelash growth, keratoconjunctivitis sicca, and keratitis, have been reported in patients receiving the drug.
Patients receiving concomitant anti-angiogenic agents, corticosteroids, nonsteroidal anti-inflammatory drugs, or taxane-based chemotherapy agents or those with a history of peptic ulcer disease or diverticular disease are at increased risk for GI perforation. Erlotinib should be permanently discontinued in patients who develop GI perforation.
Health care professionals are also advised to interrupt or discontinue treatment with erlotinib in patients who experience bullous, blistering, or exfoliative skin conditions such as Stevens-Johnson syndrome and in those with ocular eye disorders.
Erlotinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one previous chemotherapy regimen and for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer. Adverse events can be reported by calling 1-877-TARCEVA (1-877-827-2382).
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