Safety Profile

Side effects were generally manageable – discontinuation was minimal among patients with metastatic disease

  • 1.5% of patients in the pivotal trial discontinued treatment with PROVENGE due to adverse events1
Most Common Adverse Events (≥15%) Reported in the PROVENGE Group1*
Adverse Events

*All grades reported in ≥15% of patients randomized to PROVENGE; the safety analysis is based on 601 patients with prostate cancer in the PROVENGE group who underwent at least one leukapheresis procedure in phase 3 clinical trials.1

Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting

  • Most common acute infusion reactions (≥ 20%) were chills, fever, and fatigue1
  • 95.1% of acute infusion reactions were mild or moderate in severity1

PROVENGE does not require dosage adjustments, monitoring of liver/kidney functions, or concomitant steroids