Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
PATIENT COUNSELING INFORMATION
Patients should be informed that:
- LUPRON DEPOT is usually continued, often with additional medication, after the development of metastatic castration-resistant prostate cancer. (addition)
WARNINGS AND PRECAUTIONS
Effect on QT/QTc Interval
- Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Changes in Bone Density
- Table 4 is revised to add the 95% confidence intervals (CIs) for the mean percent change from baseline in bone mineral density of lumbar spine in women treated with Lupron alone or Lupron plus norethindrone acetate.
- minor editorial/formatting changes