Label Changes for:

Hycamtin (topotecan hydrochloride) capsules

June 2010

Changes have been made to the 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) – June 2010

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease
  • Hycamtin has been associated with reports of interstitial lung disease (ILD), some of which have been fatal. Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation, and use of pneumotoxic drugs and/or colony stimulating factors. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e.g., cough, fever, dyspnea, and/or hypoxia), and Hycamtin should be discontinued if a new diagnosis of ILD is confirmed.

ADVERSE REACTIONS

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