Beovu · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-098901 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile Wet AMD For wet AMD, a total of 1 088 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 730 patients were treated with the recommended dose of 6 mg. 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%). DME For DME, a total of 558 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 368 patients were treated with the recommended dose of 6 mg. The most frequently reported adverse reactions were cataract (9.0%), conjunctival haemorrhage (6.5%) and intraocular pressure increased (5.4%). The most serious adverse reactions were cataract (9.0%), retinal vascular occlusion (1.1%), retinal artery occlusion (0.8%), and endophthalmitis (0.5%). Tabulated list of adverse reactions The adverse reactions experienced following administration of Beovu in clinical studies are summarised in Table 1 below. Adverse reactions (Table 1) 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. Table 1 Frequencies of adverse reactions in clinical studies MedDRA System organ class Frequency category* Immune system disorders Hypersensitivity (including urticaria, rash, pruritus, Common erythema) Eye disorders Visual acuity reduced Common Retinal haemorrhage Common Uveitis Common Iridocyclitis Common Iritis Common Retinal vascular occlusion Common Vitreous haemorrha

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HOS-098897 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with active or suspected ocular or periocular infections. Patients with active intraocular inflammation.

HOS-098896 · has-indication-information · PDF-Seite 2

Beovu is indicated in adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1). 2

HOS-098899 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed.

HOS-098900 · has-pregnancy-information · PDF-Seite 7

Women of childbearing potential Women of childbearing potential should use effective contraception during treatment with brolucizumab and for at least one month after the last dose when stopping treatment with brolucizumab. Pregnancy There are no or limited amount of data from the use of brolucizumab in pregnant women. A study in pregnant cynomolgus monkeys did not indicate any harmful effects with respect to reproductive toxicity. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Although the systemic exposure after ocular administration is very low due to its mechanism of action, there is a potential risk to embryofoetal development. Therefore, brolucizumab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. Breast-feeding It is unknown whether brolucizumab is excreted in human milk. In a reproductive toxicity study, brolucizumab was not detected in the maternal milk or infant serum of cynomolgus monkeys (see section 5.3). A risk to the breast-fed newborn/infant cannot be excluded. Brolucizumab is not recommended during breast-feeding and breast-feeding should not be started for at least one month after the last dose when stopping treatment with brolucizumab. A decision must be made whether to discontinue breast-feeding or to abstain from brolucizumab therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility No reproductive or fertility studies have been conducted. VEGF inhibition has been shown to affect follicular development, corpus luteum function and fertility. Based on the mechanism of action of VEGF inhibitors, there is a potential risk for female reproduction.

HOS-098898 · has-warning-information · PDF-Seite 5

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Endophthalmitis, intraocular inflammation, traumatic cataract, retinal detachment, retinal tear, retinal vasculitis, and/or retinal vascular occlusion Intravitreal injections, including those with Beovu, have been associated with endophthalmitis, intraocular inflammation, traumatic cataract, retinal detachment and retinal tear (see section 4.8). Proper aseptic injection techniques must always be used when administering Beovu. Patients should be instructed to report any symptoms suggestive of the above-mentioned events without delay. Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, has been reported with the use of Beovu (see sections 4.3 and 4.8). A higher number of intraocular inflammation events were observed among patients with treatment-emergent antibodies. After investigation, retinal vasculitis and/or retinal vascular occlusion were found to be immune-mediated events. Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, may occur following the first intravitreal injection and at any time of treatment. These events were observed more frequently at the beginning of the treatment. Based on clinical studies these events were more frequent in female patients treated with Beovu than male patients (e.g. 5.3% females vs. 3.2% males in HAWK and HARRIER) and in Japanese patients. In patients developing these events, treatment with Beovu should be discontinued and the events should be promptly managed. Patients treated with Beovu with a medical history of intraocular inflammation and/or retinal vascular occlusion (within 12 months prior to the first brolucizumab injection) should be closely monitored, since they are at increased risk of developing retinal vasculitis and/or retinal vascular occlusion. The interval between two Beovu doses during maintenance treatment should not be less than 8 weeks considering that a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion was reported in patients with nAMD who received Beovu every 4 week maintenance dosing in a clinical study compared to patients who received Beovu every 8 or 12 week maintenance dosing in the pivotal Phase

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