
BEOVU DATA
Safety Profile
Common adverse drug reactions (≥1%) in HAWK and HARRIER (pooled data) through Week 961


*Including vision blurred, visual acuity reduced, visual acuity reduced transiently, and visual impairment.1
†Including anterior chamber cell, anterior chamber flare, anterior chamber inflammation, chorioretinitis, eye inflammation, iridocyclitis, iritis, retinal vasculitis, retinal vascular occlusion, uveitis, vitreous haze, vitritis.1
‡Including urticaria, rash, pruritus, erythema.1
§Including blindness, blindness transient, amaurosis, and amaurosis fugax.1
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In HAWK, 3.1% of patients in the BEOVU arm discontinued due to ocular adverse events
vs 3.3% for aflibercept2 -
In HARRIER, 3.5% of patients in the BEOVU arm discontinued due to ocular adverse events
vs 1.6% for aflibercept3
Patient monitoring and counseling*
BEOVU is contraindicated in1:
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Patients with ocular or periocular infections
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Patients with active intraocular inflammation
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Patients with known hypersensitivity to brolucizumab or any of the excipients in BEOVU
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Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation
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Guidance1:
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Advise patients there is a risk of developing endophthalmitis, retinal detachment, retinal vasculitis, and/or retinal vascular occlusion in the days following BEOVU administration
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Reports of retinal vasculitis and/or retinal vascular occlusion typically occurred in the presence of intraocular inflammation
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Patients should be monitored for increased intraocular pressure immediately following the intravitreal injection. Monitoring may include checking for perfusion of the optic nerve head or tonometry
Patients should be instructed to seek immediate care from an ophthalmologist if the eye becomes:
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Red
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Sensitive to light
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Painful
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Or if any change in vision develops
*This is a subset of information from the Prescribing Information. As always, please review the full Prescribing Information.
References: 1. BEOVU [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2020. 2. Data on file. RTH258-C001 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018. 3. Data on file. RTH258-C002 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018.