Other safety alerts
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| Australia: Updated warnings of faricimab (Vabysmo): retinal vasculitis risk |
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Therapeutic Goods Administration (TGA) announces that TGA’s 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).
TGA’s Pharmacovigilance Branch undertook a signal investigation in Nov 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.
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 therapies.
A search of TGA’s Adverse Events Management System database on 19 Dec 2023 for ‘faricimab’ and reaction terms ‘vasculitis’ and ‘retinal vasculitis’ returned 3 related adverse event reports.
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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/updated-warnings-faricimab-vabysmo-retinal-vasculitis-risk
In Hong Kong, there is one registered pharmaceutical product containing faricimab, namely Vabysmo Solution For Intravitreal Injection 6mg/0.05ml (HK-67656). The product is registered by Roche Hong Kong Limited. It is a prescription-only medicine. So far, the Department of Health (DH) has received 5 cases of adverse drug reaction related to faricimab, but these cases were not related to retinal vasculitis or retinal occlusive vasculitis. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Mar 21, 2024
Issued at HKT 15:30
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