Label Changes for:

Velcade (bortezomib) for injection

December 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009

WARNINGS and PRECAUTIONS

Hepatic Impairment
  • Bortezomib is metabolized by liver enzymes.  Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with Velcade at reduced starting doses and closely monitored for toxicities

USE IN SPECIFIC POPULATIONS

Patients with Hepatic Impairment
  • The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients.  
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