Updated warnings of faricimab (Vabysmo) retinal vasculitis risk

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 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.