Genentech and OSI Pharmaceuticals have informed Healthcare Professionals of new safety information regarding Tarceva ( Erlotinib ).
Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
In combination with Gemcitabine ( Gemzar ), Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.
This new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports.
The following new information has been added to the Warnings and Precautions section in the full prescribing information:
Gastrointestinal perforation ( including fatalities ) has been reported in patients receiving Tarceva. Patients receiving concomitant anti-angiogenic agents, corticosteroids, non-steroidal anti-inflammatory drugs ( NSAIDs ), and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
Bullous, blistering and exfoliative skin conditions have been reported, including cases suggestive of Stevens-Johnson syndrome / toxic epidermal necrolysis, which in some cases were fatal. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
Corneal perforation or ulceration have been reported during use of Tarceva. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis have been observed with Tarceva treatment and are known risk factors for corneal ulceration / perforation. Interrupt or discontinue Tarceva therapy if patients present with acute / worsening ocular disorders such as eye pain.
Source: FDA, 2009
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