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Label Changes for:

Tarceva (erlotinib) Tablets

April 2009

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

Sections added

  • Gastrointestinal Perforation
  • Bullous and Exfoliative Skin Disorders
  • Ocular Disorders

WARNINGS and PRECAUTIONS

  • Gastrointestinal Perforation
    • Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva.  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 increased risk.  Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
  • Bullous and Exfoliative Skin Disorders
    • 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.
  • Ocular Disorders
    • Corneal perforation and 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.

ADVERSE REACTIONS

  • Gastrointestinal Disorders
    • Gastrointestinal perforations have been reported in patients in clinical studies and during post-marketing use of Tarceva.
  • Ocular Disorders
    • Corneal ulcerations or perforations have been reported in patients receiving Tarceva treatment. Abnormal eyelash growth including in-growing eyelashes, excessive growth and thickening of the eyelashes have been reported and are risk factors for corneal ulceration/perforation. 
  • Skin, Hair and Nail Disorders
    • Bullous, blistering and exfoliative skin conditions have been reported, including cases suggestive of Stevens-Johnson syndrome/Toxic epidermal necrolysis.
    • ...Skin reactions may occur or worsen in sun exposed areas; therefore, the use of sunscreen or avoidance of sun exposure is recommended...Also, hyperpigmentation..
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