TGA Updated warnings of faricimab (Vabysmo) retinal vasculitis risk

TGA Updated warnings of faricimab (Vabysmo) retinal vasculitis risk

Faricimab is indicated for:

Neovascular (wet) age-related macular degeneration (nAMD) and 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).

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.

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.

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.

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.

Learn more at: Updated warnings of faricimab (Vabysmo) retinal vasculitis risk | Therapeutic Goods Administration (TGA)