Lupron Depot (leuprolide acetate) for depot suspension

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

June 2016

Summary View


Patients should be informed that:

  • LUPRON DEPOT is usually continued, often with additional medication, after the development of metastatic castration-resistant prostate cancer. (addition)


June 2014

Summary View

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.


June 2011

Summary View


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


Page Last Updated: 07/07/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English