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.
