Bevacizumab (Avastin®) and Risk of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) and Nasal Septum Perforation
September 27, 2006
Genentech updated the labeling to the bevacizumab (Avastin®) prescribing information to include warnings regarding a rare brain-capillary leak syndrome [reversible posterior leukoencephalopathy syndrome (RPLS)] and nasal septum perforation. Clinical studies and post-marketing data reveal that RPLS occurs at a rate of <0.1%. Signs and symptoms of RPLS include headache, seizure, lethargy, confusion, blindness, and hypertension. Discontinue bevacizumab in patients with magnetic resonance imaging-confirmed RPLS and treat hypertension if necessary.
Cases of nasal septal perforation have also been reported in post-marketing data. Changes to the Adverse Events section of the prescribing information now reflect this new information.
Additional information is available at the following links:
- MedWatch Alert:
- Letter to Healthcare Professionals:
- Revised Product Information:
September 27, 2006; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.