BEOVU SIDE EFFECTS
- Generic Name: brolucizumab-dbll for intravitreal injection
- Brand Name: Beovu
- Drug Class: Macular Degeneration Agents
The following potentially serious adverse reactions are described elsewhere in the labeling:
- Endophthalmitis and Retinal Detachment.
- Retinal Vasculitis and/or Retinal Vascular Occlusion.
- Increase in Intraocular Pressure.
- Thromboembolic Events.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
A total of 1088 patients, treated with brolucizumab, constituted the safety population in the two controlled neovascular AMD Phase 3 studies (HAWK and HARRIER) with a cumulative 96 week exposure to BEOVU, and 730 patients treated with the recommended dose of 6 mg.
Adverse reactions reported to occur in ≥ 1% of patients who received treatment with BEOVU pooled across HAWK and HARRIER, are listed below in Table 1.
Table 1: Common Adverse Reactions (≥ 1%) in the HAWK and HARRIER wet AMD Clinical Trials
|Adverse Drug Reactions||BEOVU
(N = 730)
|Active Control (aflibercept)
(N = 729)
|Intraocular pressure increased||4%||5%|
|Retinal pigment epithelial tear||3%||1%|
|Retinal artery occlusion||1%||< 1%|
|Retinal detachment||1%||< 1%|
|Abnormal sensation in eye||1%||2%|
|Detachment of retinal pigment epithelium||1%||< 1%|
|aIncluding vision blurred, visual acuity reduced, visual acuity reduced transiently, and visual impairment.
bIncluding anterior chamber cell, anterior chamber flare, anterior chamber inflammation, chorioretinitis, eye inflammation, iridocyclitis, iritis, retinal vasculitis, retinal vascular occlusion, uveitis, vitreous haze, vitritis.
cIncluding urticaria, rash, pruritus, erythema.
dIncluding blindness, blindness transient, amaurosis, and amaurosis fugax.
In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (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 two BEOVU doses during maintenance treatment should not be less than 8 weeks.
As with all therapeutic proteins, there is a potential for an immune response in patients treated with BEOVU. The immunogenicity of BEOVU was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to BEOVU in immunoassays. The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to BEOVU with the incidence of antibodies to other products may be misleading.
Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 52% of treatment naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 67% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune mediated adverse events related to exposure to BEOVU. This treatment emergent antibody response may develop following the first intravitreal injection.
Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.
SRC: NLM .