Clinical Safety Profile
Common adverse drug reactions (≥1%) in HAWK and HARRIER (pooled data) through Week 961*
*Data for BEOVU 6 mg. BEOVU 6 mg is the only dose available for commercial use.
†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
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:
Patients with ocular or periocular infections
Patients with active intraocular inflammation
Patients with known hypersensitivity to brolucizumab or any of the excipients in BEOVU
Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation
Advise patients there is a risk of developing endophthalmitis, retinal detachment, retinal vasculitis, and/or retinal vascular occlusion in the days following BEOVU administration
Reports of retinal vasculitis and/or retinal vascular occlusion typically occurred in the presence of intraocular inflammation
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
These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored.
Patients should be instructed to seek immediate care from their ophthalmologist if they experience any of the following symptoms or any change in vision1:
¶This is a subset of information from the Prescribing Information. As always, please review the full Prescribing Information.
The Vision Monitoring Guide was developed to help your patients monitor their vision at home and know what to do if they experience changes in vision.
References: 1. BEOVU [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2022. 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. 4. ASRS Member Update: Novartis-Appointed Safety Review Committee Reports Initial Brolucizumab Findings. Preliminary report available June 4, 2020. https://www.asrs.org/clinical/clinical-updates. Accessed on November 18th, 2020.