Label Changes for:

Hycamtin (topotecan) capsules

June 2014

Changes have been made to the PRECAUTIONS sections of the safety label.

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

 

June 2014

USE IN SPECIFIC POPULATIONS

Renal Impairment
  • The systemic exposure to both topotecan lactone and total topotecan increased in patients with renal impairment compared with that in patients with normal renal function. No dosage adjustment is recommended for patients with mild renal impairment (CLcr = 50-79 mL/min). Adjust the dose of Hycamtin capsules in patients with moderate (CLcr = 30-49 mL/min) and severe (CLcr <30 mL/min) renal impairment. 

 

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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