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Association of TARCEVA (erlotinib) with cases of gastrointestinal perforation, Stevens-Johnson syndrome, and corneal perforation - For Health Professionals

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Contact: Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)

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This is duplicated text of a letter from Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on TARCEVA (erlotinib)

May 8, 2009

Subject: Information on the association of TARCEVA^® (erlotinib) with cases of gastrointestinal perforation, Stevens-Johnson syndrome, and corneal perforation

Dear Health Care Professional,

Hoffmann-La Roche Limited, in consultation with Health Canada would like to inform prescribers of important new safety information regarding the use of TARCEVA^® (erlotinib). Roche is issuing this letter to ensure that you have the most recent information available when considering TARCEVA as a treatment option for its approved uses.

TARCEVA is a Human Epidermal Growth Factor Receptor Type 1/Epidermal Growth Factor Receptor (HER1/EGFR) tyrosine kinase inhibitor. It is authorized as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown.

As part of routine pharmacovigilance activities, Roche has evaluated signals generated by its internal signal detection system pertaining to gastrointestinal disorders, skin toxicities and ocular disorders reported from clinical trials, spontaneous reports, and literature. Based on these evaluations, the following recommendations are made:

Gastrointestinal Perforation:
Rare cases of gastrointestinal perforations (115) have been reported in patients treated with TARCEVA from clinical trials, spontaneous reports, and literature. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at greater risk for developing gastrointestinal perforation. Treatment with TARCEVA should be interrupted or discontinued in patients who develop gastrointestinal perforation.

Bullous and exfoliative skin disorders:
Very rare cases of bullous, blistering, or exfoliating skin conditions suggestive of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (10), which in some cases were fatal, have been reported in patients treated with TARCEVA from clinical trials and spontaneous reports. TARCEVA treatment should be interrupted or discontinued in patients who develop severe bullous, blistering, or exfoliating skin conditions.

Ocular Disorders:
Very rare cases of corneal perforation (6) have been reported in patients treated with TARCEVA from clinical trials and spontaneous reports. Corneal ulceration is a known adverse event associated with TARCEVA and has previously been documented within the current Product Monograph. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis have also been reported with TARCEVA treatment, which are risk factors for corneal perforation/ulceration. TARCEVA therapy should be interrupted or discontinued in patients who develop acute/worsening ocular disorders (e.g., eye pain).

The TARCEVA Product Monograph is currently being reviewed by Health Canada in conjunction with the manufacturer regarding the above mentioned safety concerns and will be updated accordingly.

Managing marketed health product related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients receiving TARCEVA should be reported to Hoffmann-La Roche Limited, or Health Canada at the following addresses:

Should you have any questions or require additional information regarding the use of TARCEVA, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.

Sincerely,

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited