Beovu

Beovu Adverse Reactions

brolucizumab

Manufacturer:

Alcon-Couvreur

Distributor:

Zuellig
/
Firma Chun Cheong

Marketer:

Novartis
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: The most frequently reported adverse reactions were reduced visual acuity (7.3%), cataract (7.0%), conjunctival haemorrhage (6.3%) and vitreous floaters (5.1%).
The most serious adverse reactions were blindness (0.8%), endophthalmitis (0.7%), retinal artery occlusion (0.8%) and retinal detachment (0.7%).
Tabulated list of adverse reactions: Adverse reactions (Table 2) are listed according to the MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories for each adverse reaction are based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 2.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Immunogenicity: There is a potential for an immune response in patients treated with Beovu. After dosing with Beovu for 88 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 23-25% of patients. Among patients with treatment-emergent antibodies, a higher number of intraocular inflammation adverse reactions were observed. The clinical significance of anti-brolucizumab antibodies on safety is unclear at this time. Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.
Product-class-related adverse reactions: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors. A low incidence rate of arterial thromboembolic events was observed in the brolucizumab clinical studies in patients with AMD. There were no major notable differences between the groups treated with brolucizumab and comparator.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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