Label Changes for:

Hycamtin (topotecan) Capsules

October 2011

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011

 

 

CONTRAINDICATIONS

  • ...should not be used in patients with severe bone marrow depression

 

WARNINGS AND PRECAUTIONS

Interstitial lung disease
  • interstitial lung disease..... added

 

ADVERSE REACTIONS

Postmarketing Experience
  • Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease.
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