Tuesday, October 4, 2011

Bevacizumab- change in label

On 30th September, 2011, US FDA informed that changes in bevacizumab (Avastin, Genentech, Inc.) package insert regarding: risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event have been made.
These changes include the following:
  • Warning subsection added- increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy. It also states a recommendation that females of reproductive potential be informed of the increased risk of ovarian failure prior to starting treatment with bevacizumab,
  • Osteonecrosis of the jaw is an adverse reaction of bevacizumab,
  • new information regarding the risks of venous thromboembolic events and bleeding in patients receiving anti-coagulation therapy after first VTE event while receiving bevacizumab.