Endophthalmitis, retinal detachment, retinal vasculitis and/or retinal vascular occlusion: Intravitreal injections, including those with Brolucizumab (Vsiqq), have been associated with endophthalmitis and retinal detachment. Proper aseptic injection techniques must always be used when administering Brolucizumab (Vsiqq).
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Brolucizumab (Vsiqq). These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with Brolucizumab (Vsiqq) in patients who develop these events. Patients treated with Brolucizumab (Vsiqq) who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored (see CONTRAINDICATIONS and ADVERSE REACTIONS).
Patients should be instructed to report any symptoms suggestive of the previously mentioned events without delay.
In a Phase IIIa clinical study (MERLIN), patients with nAMD who received Brolucizumab (Vsiqq) every 4 week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received Brolucizumab (Vsiqq) every 8 or 12 week maintenance dosing in the pivotal Phase III clinical studies (HAWK and HARRIER). The interval between two Vsiqq doses during maintenance treatment should not be less than 8 weeks (see DOSAGE & ADMINISTRATION).
Intraocular pressure increases: Transient increases in intraocular pressure have been seen within 30 minutes of injection, similar to those observed with intravitreal administration of other VEGF inhibitors (see ADVERSE REACTIONS). Sustained intraocular pressure increases have also been reported with Brolucizumab (Vsiqq). Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately.
Driving and using machines: Patients may experience temporary visual disturbances after an intravitreal injection with Brolucizumab (Vsiqq) and the associated eye examination, and should therefore be advised not to drive or use machinery until visual function has recovered sufficiently.
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