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U.S. Department of Health and Human Services


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Tykerb (lapatinib) tablets

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


Summary View



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


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