Dear Healthcare Professional Letter on new information regarding the safety of Tarceva (erlotinib)
25.05.2009
In cooperation with the Agency for Medicinal Products and Medical Devices, on 25 May 2009, Roche d.o.o. sent a Dear Healthcare Professional Letter to prescribing physicians regarding the new information on safety of Tarceva film tablets (erlotinib).
Erlotinib is an inhibitor of the epidermal growth factor inhibitor tyrosine kinase (EFGR, known as HER1). Tarceva is indicated in the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Also, in combination with gemcitabine, Tarceva is indicated for treatment of patients with a metastatic pancreatic cancer.
The letters are meant to inform physicians about the new concerns and precautions in use of the active substance erlotinib.
Gastrointestinal perforation
The patients treated with Tarceva are at increased risk of developing gastrointestinal perforations, which nevertheless occur only rarely.
The increased risk is observed in patients concomitantly taking antiangiogenetic agents, corticosteroids, non-steroid anti-inflammatory medicines and/or chemotherapy based on taxanes and in patients with a history of peptic ulcer or diverticular disease. In patients developing a gastrointestinal perforation, the treatment of Tarceva should be discontinued.
Bullous and exfoliative skin disorders
Bullous and exfoliative skin changes have been observed, including very rare cases (less than 1 per 10000 patients) suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis, which in some cases had a fatal outcome.
The treatment with Tarceva should be interrupted or discontinued if the patient develops serious bullous or exfoliative skin changes.
Ocular disorders
Very rare cases of corneal perforation or ulceration have been reported during use of Tarceva. Other ocular disorders such as abnormal eyelash growth, keratoconjuctivitis sicca or keratitis observed during Tarceva treatment represent risk factors for corneal perforation or ulceration. The treatment with Tarceva should be interrupted or discontinued if patients experience acute or worsening ocular disorders, such as eye pain.
The Summary of Product Characteristics will be amended with appropriate information which have been reviewed and endorsed by EMEA's CHMP and approved by the Agency for Medicinal Products and Medical Devices.
The text of the letter can be found below:
"New safety information on use of Tarceva (erlotinib)"
