• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Tykerb (lapatinib) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

 

Summary View

 

CONTRAINDICATIONS 

  • Tykerb is contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components.

ADVERSE REACTIONS

Postmarketing Experience
  • Immune System Disorders: Hypersensitivity reactions including anaphylaxis
  • Skin and Subcutaneous Tissue Disorders: Nail disorders including paronychia