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New warning, safety information issued for erlotinib
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FDA MedWatch informed health care professionals on Friday of new safety information added to the warnings and precautions portion of the prescribing information for erlotinib, based on an April letter from OSI Pharmaceuticals and Genentech informing health care professionals of the important changes.
Pharmacovigilence activities conducted in clinical study and postmarketing reports led to the addition of new information.
The use of erlotinib (Tarceva, OSI/Genentech) has been associated with reports of gastrointestinal perforation, including some fatalities. According to the letter, patients taking concomitant anti-angiogenic agents, corticosteroids, NSAIDs and/or taxane-based chemotherapy or those who have a history of peptic ulceration or diverticular disease are at an increased risk for gastrointestinal perforation.
Other reports include bullous, blistering and exfoliative skin conditions suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis. The letter recommends interrupting or discontinuing treatment if a patient develops severe symptoms.
Additionally, ocular disorders, such as corneal perforation or ulceration, have been reported while using erlotinib. Risk factors for corneal ulceration or perforation, including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis, were also reported. Patients who present with acute or worsening ocular disorders like eye pain should interrupt or discontinue treatment.
Erlotinib is indicated as monotherapy in patients with locally advanced or metastatic non–small cell lung cancer who have failed at least one prior chemotherapy regimen. The drug is also indicated for first-line treatment of patients with locally advanced, unresectable or mestatatic pancreatic cancer when used in combination with gemcitabine.