BEOVU (brolucizumab-dbll)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Ocular infection

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Ocular inflammation
Pregnancy

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Ocular hypertension

There are 18 severe adverse reactions.

More Frequent	Less Frequent
Cataracts	Corneal abrasion Hypersensitivity drug reaction Punctate keratitis Retinal hemorrhage Retinal tear Retinal vascular occlusion Tear of retinal pigment epithelium Transient blindness Vitreous detachment

Rare/Very Rare
Amaurosis Arterial thrombosis Endophthalmitis Ocular hypertension Retinal detachment Retinal pigment epithelial detachment Retinal vasculitis Vitreous hemorrhage

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Blurred vision Conjunctival hemorrhage Ocular pain Vitreous floater	Conjunctival hyperemia Conjunctivitis Erythema Eye tearing Foreign body sensation of eye Ocular inflammation Pruritus of skin Skin rash Urticaria

Rare/Very Rare
Scleritis

There are no adequate and well-controlled studies of brolucizumab in pregnant women. Based on its mechanism of action, brolucizumab may adversely affect embryofetal development or reproductive capacity. In animal studies, VEGF inhibition has been shown to cause malformations, embryofetal resorption, and decreased fetal weight and also to affect follicular development, corpus luteum function, and fertility.

Brolucizumab should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Women of reproductive potential should be advised to use highly effective methods of contraception during brolucizumab therapy and for at least one month after the last dose of the drug.

It is not known whether brolucizumab distributes into human milk, affects the breast-fed infant, or affects milk production. Breast-feeding is not recommended during brolucizumab therapy and for at least one month after the last dose of the drug.

In clinical trials, approximately 90% of patients receiving brolucizumab-dbll were 65 years of age or older and 60% were 75 years of age or older. No substantial differences in efficacy or safety were observed with increasing age in these studies. No dosage adjustment is required in patients 65 years of age or older.