The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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) - external site and Consumer Medicine Information (CMI) - external site.
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.
Background
Faricimab is indicated for:
- neovascular (wet) age-related macular degeneration (nAMD)
- diabetic macular oedema (DMO)
Faricimab 6 mg/0.05 mL intraocular injection, 0.05 mL vial is currently listed on the PBS - external site as an ocular vascular disorder agent with Authority Required (Streamlined).
Our Pharmacovigilance Branch undertook a signal investigation in November 2023 to assess the risk of retinal vasculitis and/or retinal occlusive vasculitis with faricimab.
Retinal vasculitis and retinal occlusive vasculitis are serious adverse events that could lead to permanent vision loss and require prompt diagnosis and management.
The US label for faricimab already includes ‘retinal vasculitis and/or retinal vascular occlusion’ in the respective warning and precaution section.
Additional warnings added to the Australian PI
4.4 Special warnings and precautions for use
Retinal Vasculitis and/or Retinal Occlusive Vasculitis
Retinal vasculitis and/or retinal occlusive vasculitis, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo in the postmarketing setting. Discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay (see section 4.8).
4.8 Adverse effects (undesirable effects)
Postmarketing Experience
Rare cases of retinal vasculitis and/or retinal occlusive vasculitis have been spontaneously reported in the postmarketing setting. Retinal vasculitis and retinal occlusive vasculitis have also been reported in patients treated with intravitreal (IVT) therapies.
Cases reported to us
A search of our Adverse Events Management System (AEMS) database on 19 December 2023 for ‘faricimab’ and reaction terms ‘vasculitis’ and ‘retinal vasculitis’ returned 3 related adverse event reports.