Summary
Our investigation into the risk of retinal vasculitis and/or
retinal occlusive vasculitis in patients being treated with faricimab (Vabysmo)
found that stronger warnings regarding this risk were needed in the Product Information (PI) and Consumer Medicine Information (CMI).
Sections 4.4 and 4.8 of the Vabysmo PI were updated to reflect
the additional safety information and a Dear Health Care Professional letter
was sent to ophthalmologists who prescribe intravitreal injections. The CMI was
updated to reflect the changes.
What health professionals should do
Health professionals should be alert to the updated warnings
and should inform patients and carers of the potential retinal vasculitis
and/or retinal occlusive vasculitis risk associated with faricimab use.
See the full article on the TGA website.
Reproduced with
permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 20
March 2024.
