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U.S. Department of Health and Human Services


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Hycamtin (topotecan hydrochloride) capsules

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

Summary View


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.


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