Clinical Safety Profile
Common Adverse Reactions (≥1%) in the AMD and DME
In a clinical study (MERLIN), patients with wet AMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of IOI (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8- or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between 2 BEOVU doses during maintenance treatment should not be less than 8 weeks.1
In KESTREL, 2.1% of patients in the BEOVU arm discontinued due to AEs vs 3.2% for aflibercept2
In KITE, 3.9% of patients in the BEOVU arm discontinued due to AEs vs 3.9% for aflibercept3
In KESTREL, 1 subject in the BEOVU 6 mg arm had both retinal vasculitis and retinal vascular occlusion; both events resolved without treatment4
In KITE, both retinal occlusion events were reported as retinal artery occlusion and were not associated with IOI or retinal vasculitis4
In patients developing these events, treatment with BEOVU should be discontinued and the events should be promptly managed
AE=adverse event; AMD=age-related macular degeneration; DME=diabetic macular edema; IOI=intraocular inflammation; VA=visual acuity.
aIncluding vision blurred, VA reduced, VA reduced transiently, and visual impairment.1
bIncluding anterior chamber cell, anterior chamber flare, anterior chamber inflammation, chorioretinitis, eye inflammation, iridocyclitis, iritis, retinal vasculitis, retinal vascular occlusion, uveitis, vitreous haze, and vitritis.1
cIncluding urticaria, rash, pruritus, and erythema.1
dIncluding blindness, blindness transient, amaurosis, and amaurosis fugax.1
Patient monitoring & 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. 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 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 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; May 2022. 2. Data on file. CRTH258B2301 FIR v1.0. Novartis Pharmaceuticals Corp; 2020. 3. Data on file. CRTH258B2302 FIR v2.0. Novartis Pharmaceuticals Corp; 2020. 4. Brown D, Wolf S, Garweg JG, et al. Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KESTREL & KITE studies. Presented at: ARVO; May 1-7, 2021.