Published: May 2009

Avastin - "off label" intraoccular administration

Prescriber Update 30(2): 10
May 2009

An increase in eye-related adverse reactions has been identified following administration of Avastin into the vitreous humour.

Avastin is an antineoplastic agent containing bevacizumab. Bevacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutrialises the biological activity of human vascular endothelial growth factor (VEGF).

Avastin is approved in New Zealand for the treatment of:

In addition to the indications listed above, Medsafe understands that intraocular Avastin is also widely used throughout New Zealand for the treatment of neovascular age-related macular degeneration (AMD).

The manufacturer of Avastin has reported two clusters of eye-related adverse reactions following intraoccular administration in Canada (25 reports in total). In addition, five reports of eye-related adverse reactions following the use of intraoccular Avastin have been received in New Zealand. Reports include reactions such as eye inflammation, endophthalmitis, blurred vision, and the presence of “floaters”. Although a causal relationship is yet to be proven, the manipulation of Avastin single use vials into multiple aliquots for intraoccular administration may increase the risk of contamination.

Prescribers are reminded that the use of intraoccular Avastin for the treatment of AMD is not approved in New Zealand and constitutes “off-label” use. As adverse reactions to medicines used off-label are under-reported, emerging safety signals can be difficult to identify. Prescribers are asked to report all adverse reactions to CARM.

Medsafe will continue to monitor eye-related adverse reactions associated with the use of Avastin and communicate further advice to prescribers as necessary.