• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Zolinza (vorinostat) capsules

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

 

Summary View

 

WARNINGS AND PRECAUTIONS

QTC Prolongation (removed)

CLINICAL PHARMACOLOGY

Pharmacodynamics
  • A randomized, partially-blind, placebo-controlled, 2-period crossover study was performed to assess the...
  • In clinical studies in patients with CTCL, three of 86 CTCL patients exposed to 400 mg once daily had Grade 1 (>450-470 msec) or 2 (>470-500 msec or increase of >60 msec above baseline) clinical adverse..