Beovu
1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

2 

This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 

See section 4.8 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Beovu 120 mg/ml solution for injection in pre-filled syringe 

Beovu 120 mg/ml solution for injection 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

One ml solution for injection contains 120 mg of brolucizumab*. 

 

* Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment produced in 

Escherichia coli cells by recombinant DNA technology. 

 

Beovu 120 mg/ml solution for injection in pre-filled syringe 

 

Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml solution. This provides a usable 

amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab. 

 

Beovu 120 mg/ml solution for injection 

 

Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This provides a usable amount to deliver 

a single dose of 0.05 ml solution containing 6 mg of brolucizumab. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Solution for injection (injection). 

 

Clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 
 

Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration 

(AMD). 

 



 

3 

4.2 Posology and method of administration 

 

Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections. 

 

Posology 

 

The recommended dose is 6 mg brolucizumab (0.05 ml solution) administered by intravitreal injection 

every 4 weeks (monthly) for the first 3 doses. Thereafter, the physician may individualise treatment 

intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. A 

disease activity assessment is suggested 16 weeks (4 months) after treatment start. In patients without 

disease activity, treatment every 12 weeks (3 months) should be considered. In patients with disease 

activity, treatment every 8 weeks (2 months) should be considered. The physician may further 

individualise treatment intervals based on disease activity. 

 

If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, 

Beovu should be discontinued. 

 

Special populations 

Elderly 

No dosage adjustment is required in patients aged 65 years or above (see section 5.2). 

 

Renal impairment 

No dosage adjustment is required in patients with renal impairment (see section 5.2). 

 

Hepatic impairment 

Brolucizumab has not been studied in patients with hepatic impairment. No dosage adjustment is 

required in patients with hepatic impairment (see section 5.2). 

 

Paediatric population 

The safety and efficacy of brolucizumab in children and adolescents below 18 years of age have not 

been established. No data are available. 

 

Method of administration 

 

Beovu is for intravitreal use only. 

 

The solution for injection should be inspected visually prior to administration (see section 6.6). 

 

The intravitreal injection procedure should be carried out under aseptic conditions, which includes the 

use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or 

equivalent). Sterile paracentesis equipment should be available as a precautionary measure. The 

patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to 

performing the intravitreal procedure (see section 4.3). Adequate anaesthesia and a broad-spectrum 

topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered 

prior to the injection. 

 

The injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, 

avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 

0.05 ml is then delivered slowly; a different scleral site should be used for subsequent injections. 

 

Immediately following the intravitreal injection, patients should be monitored for elevation in 

intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve 

head or tonometry. If required, sterile equipment for paracentesis should be available. 

 

Following intravitreal injection patients should be instructed to report any symptoms suggestive of 

endophthalmitis (e.g. eye pain, redness of the eye, photophobia, blurring of vision) without delay. 

 



 

4 

Pre-filled syringe 

The pre-filled syringe is for single use only. Each pre-filled syringe should only be used for the 

treatment of a single eye. 

 

Since the volume contained in the pre-filled syringe (0.165 ml) is greater than the recommended dose 

(0.05 ml), a portion of the volume contained in the pre-filled syringe must be discarded prior to 

administration. 

 

Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble 

along with excess medicinal product, the plunger should be slowly depressed until the edge below the 

dome of the rubber stopper is aligned with the 0.05 ml dose mark (equivalent to 50 µl, i.e. 6 mg 

brolucizumab). 

 

Vial 

The vial is for single use only. Each vial should only be used for the treatment of a single eye. 

 

Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml), a 

portion of the volume contained in the vial must be discarded prior to administration. 

 

Injecting the entire volume of the vial could result in overdose. To expel the air bubble along with 

excess medicinal product, the air should be carefully expelled from the syringe and the dose adjusted 

to the 0.05 ml mark (equivalent to 50 µl, i.e. 6 mg brolucizumab). 

 

For instructions on preparation of the medicinal product before administration, see section 6.6. 

 

4.3 Contraindications 
 

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. 

 

4.4 Special warnings and precautions for use 

 

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 vasculitis, 

and/or retinal vascular occlusion 

 

Intravitreal injections, including those with Beovu, have been associated with endophthalmitis, 

intraocular inflammation, traumatic cataract and retinal detachment (see section 4.8). Proper aseptic 

injection techniques must always be used when administering Beovu. 

 

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular 

inflammation, have been reported with the use of Beovu (see sections 4.3 and 4.8).In patients 

developing these events, treatment with Beovu should be discontinued and the events should be 

promptly managed. 

 

Patients should be instructed to report any symptoms suggestive of the above-mentioned events 

without delay. 

 



 

5 

Intraocular pressure increases 

 

Transient increases in intraocular pressure have been seen within 30 minutes of intravitreal injection 

with vascular endothelial growth factor (VEGF) inhibitors, including brolucizumab (see section 4.8). 

Special precaution is needed in patients with poorly controlled glaucoma (do not inject Beovu while 

the intraocular pressure is ≥30 mmHg). Both intraocular pressure and perfusion of the optic nerve head 

must be monitored and managed appropriately. 

 

Bilateral treatment 

 

The safety and efficacy of brolucizumab administered in both eyes concurrently have not been studied. 

 

Immunogenicity 

 

As this is a therapeutic protein, there is a potential for immunogenicity with brolucizumab (see 

section 4.8). Patients should be instructed to inform their physician if they develop symptoms such as 

eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased 

number of small particles in their vision, or increased sensitivity to light (see section 4.8). 

 

Concomitant use of other anti-VEGF 

 

There are no data available on the concomitant use of Beovu with other anti-VEGF medicinal products 

in the same eye. Brolucizumab should not be administered concurrently with other anti-VEGF 

medicinal products (systemic or ocular). 

 

Withholding treatment 

 

In intravitreal anti-VEGF treatments, the dose should be withheld and treatment should not be 

resumed earlier than the next scheduled treatment in the event of: 

 a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last 

assessment of visual acuity; 

 a retinal break; 

 a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is 

≥50% of the total lesion area; 

 performed or planned intraocular surgery within the previous or next 28 days. 

 

Retinal pigment epithelial tear 

 

Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF 

therapy for wet AMD include a large and/or high pigment epithelial retinal detachment. When 

initiating brolucizumab therapy, caution should be used in patients with these risk factors for retinal 

pigment epithelial tears. 

 

Rhegmatogenous retinal detachment or macular holes 

 

Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 

macular holes. 

 

Systemic effects following intravitreal use 

 

Systemic adverse events, including non-ocular haemorrhages and arterial thromboembolic events, 

have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk 

that these may relate to VEGF inhibition. There are limited data on safety in the treatment of patients 

with AMD with a history of stroke, transient ischaemic attacks or myocardial infarction within the last 

3 months. Caution should be exercised when treating such patients. 

 



 

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Sodium content 

 

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 

“sodium-free”. 

 

4.5 Interaction with other medicinal products and other forms of interaction 
 

No interaction studies have been performed. 

 

4.6 Fertility, pregnancy and lactation 
 

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. Animal 

studies are insufficient with respect to reproductive toxicity (see section 5.3). Although the systemic 

exposure after ocular administration is very low, 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. 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 inhibitiors, there is a potential risk for female reproduction, and to embryofoetal development. 

 

4.7 Effects on ability to drive and use machines 
 

Beovu has a minor influence on the ability to drive and use machines due to possible temporary visual 

disturbances following the intravitreal injection and the associated eye examination. Patients should 

not drive or use machines until visual function has recovered sufficiently. 

 

4.8 Undesirable effects 

 

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%). 

 



 

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Tabulated list of adverse reactions 

 

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 and post-marketing experience 

 

MedDRA System organ class Frequency category 

Immune system disorders 

Hypersensitivity (including urticaria, rash, pruritus, 

erythema) 

Common 

Eye disorders 

Visual acuity reduced Common 

Retinal haemorrhage Common 

Uveitis  Common 

Iritis  Common 

Vitreous detachment Common 

Retinal tear Common 

Cataract Common 

Conjunctival haemorrhage Common 

Vitreous floaters Common 

Eye pain Common 

Intraocular pressure increase Common 

Conjunctivitis Common 

Retinal pigment epithelial tear Common 

Vision blurred Common 

Corneal abrasion Common 

Punctate keratitis Common 

Blindness Uncommon 

Endophthalmitis Uncommon 

Retinal artery occlusion Uncommon 

Retinal detachment Uncommon 

Conjunctival hyperaemia Uncommon 

Lacrimation increased Uncommon 

Abnormal sensation in eye Uncommon 

Detachment of retinal pigment epithelium Uncommon 

Vitritis Uncommon 

Anterior chamber inflammation Uncommon 

Iridocyclitis Uncommon 

Anterior chamber flare Uncommon 

Corneal oedema Uncommon 

Vitreous haemorrhage Uncommon 

Retinal vascular occlusion Not known 

Retinal vasculitis Not known 

 



 

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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 via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 
 

Overdosing with greater than recommended injection volume may increase intraocular pressure. In the 

event of overdose, intraocular pressure should therefore be monitored and, if deemed necessary by the 

treating physician, appropriate treatment should be initiated. 

 

 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents, ATC code: S01LA06 

 

Mechanism of action 

 

Brolucizumab is a humanised monoclonal single chain Fv (scFv) antibody fragment with a molecular 

weight of ~26 kDa. 

 

Increased levels of signalling through the vascular endothelial growth factor A (VEGF-A) pathway are 

associated with pathological ocular angiogenesis and retinal oedema. Brolucizumab binds with high 

affinity to VEGF-A isoforms (e.g. VEGF110, VEGF121, and VEGF165), thereby preventing binding of 

VEGF-A to its receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A binding, brolucizumab 

suppresses endothelial cell proliferation, thereby reducing pathological neovascularisation and 

decreasing vascular permeability. 

 

  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

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Pharmacodynamic effects 

 

Neovascular (wet) age-related macular degeneration (AMD) is characterised by pathological choroidal 

neovascularisation (CNV). Leakage of blood and fluid from CNV may cause retinal thickening or 

oedema and/or intraretinal/subretinal haemorrhage, resulting in loss of visual acuity. 

 

In the HAWK and HARRIER studies, related anatomical parameters were part of the disease activity 

assessments guiding treatment decisions. Reductions in central subfield thickness (CST) and in 

presence of intraretinal/subretinal fluid (IRF/SRF) or sub-retinal pigment epithelium (sub-RPE) fluid 

were observed in patients treated with Beovu as early as 4 weeks after treatment initiation and up to 

week 48 and week 96. 

 

At week 16, the reduction in CST was statistically significant on Beovu versus aflibercept in both 

studies (HAWK: -161 vs. -134 microns; HARRIER: -174 vs. -134 microns). This decrease from 

baseline in CST was also statistically significant at week 48 (HAWK: -173 vs. -144 microns; 

HARRIER: -194 vs. -144 microns), and maintained to the end of each study at week 96 (HAWK: -175 

vs. -149 microns; HARRIER: -198 vs. -155 microns). 

 

At week 16, the percentage difference in patients with IRF and/or SRF fluid was statistically 

significant on Beovu versus aflibercept in both studies (HAWK: 34% vs. 52%; HARRIER: 29% vs. 

45%). This difference was also statistically significant at week 48 (HAWK: 31% vs. 45%; HARRIER: 

26% vs. 44%), and maintained to the end of each study at week 96 (HAWK: 24% vs. 37%; 

HARRIER: 24% vs. 39%). 

 

At week 16, the percentage difference in patients with sub-RPE fluid was statistically significant on 

Beovu versus aflibercept in both studies (HAWK: 19% vs. 27%; HARRIER: 16% vs. 24%). This 

difference was also statistically significant at week 48 (HAWK: 14% vs. 22%; HARRIER: 13% vs. 

22%), and maintained to the end of each study at week 96 (HAWK: 11% vs. 15%; HARRIER: 17% 

vs. 22%). 

 

In these studies, for patients treated with Beovu, reductions in CNV lesion size were observed as early 

as 12 weeks, and at weeks 48 and 96 after treatment initiation. 

 

Clinical efficacy and safety 

 

The efficacy and safety of Beovu were assessed in two randomised, multicentre, double-masked, 

active-controlled Phase III studies (HAWK and HARRIER) in patients with neovascular (wet) AMD. 

A total of 1,817 patients were treated in these studies for two years (1,088 on Beovu and 729 on 

comparator aflibercept). Patient ages ranged from 50 to 97 years, with a mean age of 76 years. 

 

In both studies, after the first three monthly doses (weeks 0, 4 and 8), brolucizumab patients were 

treated every 12 weeks, with the option of adjusting to a dosing interval every 8 weeks based on 

disease activity. Disease activity was assessed by a physician during the first 12-week interval (at 

weeks 16 and 20) and at each subsequent scheduled 12-weekly treatment visit. Patients who showed 

disease activity (e.g. decreased visual acuity, increased CST and/or presence of IRF/SRF or sub-RPE 

fluid) at any of these visits were adjusted to an 8-weekly treatment interval. The comparator 

aflibercept was administered every 8 weeks after the first 3 monthly doses. 

 

  



 

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Results 

The primary efficacy endpoint for the studies was the change from baseline in best corrected visual 

acuity (BCVA) to week 48, as measured by the early treatment diabetic retinopathy study (ETDRS) 

letter score, with the primary objective being to demonstrate non-inferiority of Beovu versus 

aflibercept. In both studies, Beovu (administered in an every 12 weeks or an every 8 weeks regimen) 

demonstrated non-inferior efficacy to aflibercept 2 mg (administered every 8 weeks). The visual acuity 

gains observed in the first year were maintained in the second year. 

 

Detailed results of both studies are shown in Table 2 and in Figure 1 below. 

 

Table 2 Visual acuity outcomes at weeks 48 and 96 in Phase III - HAWK and HARRIER 

studies 
 

  HAWK HARRIER 

Efficacy outcome Week Beovu 

6 mg 

(n=360) 

Aflibercept 

2 mg 

(n=360) 

Difference 

(95% CI) 

brolucizumab 

– aflibercept 

Beovu 

6 mg 

(n=370) 

Aflibercept 

2 mg 

(n=369) 

Difference 

(95% CI) 

brolucizumab 

– aflibercept 

Mean change from 

baseline in BCVA 

(measured by 

ETDRS letters score) 

48 6.6 

(SE=0.71) 

6.8 

(SE=0.71) 

-0.2 

(-2.1, 1.8) 

P<0.0001 a) 

6.9 

(SE=0.61) 

7.6 

(SE=0.61) 

-0.7 

(-2.4, 1.0) 

P <0.0001 a) 

36 – 

48 b) 

6.7 

(SE=0.68) 

6.7 

(SE=0.68) 

0.0 

(-1.9, 1.9) 

P<0.0001 a) 

6.5 

(SE=0.58) 

7.7 

(SE=0.58) 

-1.2 

(-2.8, 0.4) 

P=0.0003 a) 

96 5.9 

(SE=0.78) 

5.3 

(SE=0.78) 

0.5 

(-1.6, 2.7) 

6.1 

(SE=0.73) 

6.6 

(SE=0.73) 

-0.4 

(-2.5,1.6) 

% of patients who 

gained at least 

15 letters of vision 

48 33.6 25.4 8.2 

(2.2, 15.0) 

29.3 29.9 -0.6 

(-7.1, 5.8) 

96 34.2 27.0 7.2 

(1.4, 13.8) 

29.1 31.5 -2.4 

(-8.8, 4.1) 

% of patients who 

lost visual acuity (%) 

(≥15 letters of BCVA 

loss) 

48 6.4 5.5 0.9 

(-2.7, 4.3) 

3.8 4.8 -1.0 

(-3.9, 2.2) 

96 8.1 7.4 0.7 

(-3.6, 4.6) 

7.1 7.5 -0.4 

(-3.8, 3.3) 

BCVA: best corrected visual acuity; missing data are imputed using last observation carried forward (LOCF) method 

ETDRS: early treatment diabetic retinopathy study 
a) P-value referring to the non-inferiority hypothesis with a non-interiority margin of 4.0 letters. 
b) Key secondary endpoint, accounting for differences in timing of Beovu and aflibercept treatments. 

 



 

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Figure 1 Mean change in visual acuity from baseline to week 96 in HAWK and HARRIER 

studies 

 

HAWK 
 

 
HARRIER 

 

 
 

These visual acuity gains were achieved with 56% and 51% of patients treated with Beovu 6 mg on a 

12-weekly dosing interval at week 48, and with 45% and 39% of patients at week 96 in HAWK and 

HARRIER, respectively. Among patients identified as eligible for the 12-weekly regimen during the 

first 12-week interval, 85% and 82% remained on the 12-weekly dosing interval up to week 48. Of 

patients on the 12-weekly interval at week 48, 82% and 75% remained on the 12-weekly dosing 

interval up to week 96. 

 

0

1

2

3

4

5

6

7

8

9

10

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96

V
A

 c
h

an
ge

 f
ro

m
 b

as
el

in
e 

(l
et

te
rs

) 

Time (weeks)

Beovu 6 mg (n=360) aflibercept 2 mg (n=360)

0

1

2

3

4

5

6

7

8

9

10

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96

V
A

 c
h

an
ge

 f
ro

m
 b

as
el

in
e 

(l
et

te
rs

) 

Time (weeks)

Beovu 6 mg (n=370) aflibercept 2 mg (n=369)



 

12 

Treatment effects in evaluable subgroups (e.g. age, gender, race, baseline visual acuity, baseline 

retinal thickness, lesion type, lesion size, fluid status) in each study were generally consistent with the 

results in the overall populations. 

 

Disease activity was assessed by changes in visual acuity and/or anatomical parameters, including 

CST and/or presence of IRF/SRF or sub-RPE. Disease activity was assessed throughout the studies. 

Anatomical parameters of disease activity were decreased at week 48 and at week 96 for Beovu 

compared to aflibercept (see “Pharmacodynamic effects”). 

 

The percentage difference in patients with disease activity at week 16 was statistically significant on 

Beovu versus aflibercept (24% vs 35% in HAWK, p=0.0013; 23% vs 32% in HARRIER, p=0.0021). 

 

In both studies, Beovu demonstrated clinically meaningful increases from baseline in the pre-specified 

secondary efficacy endpoint of patient-reported outcomes, reported through the National Eye Institute 

Visual Function Questionnaire (NEI VFQ-25). The magnitude of these changes was similar to that 

seen in published studies, which corresponded to a 15-letter gain in BCVA. Patient-reported outcome 

benefits were maintained in the second year. 

 

No clinically meaningful differences were found between Beovu and aflibercept in changes from 

baseline to week 48 in NEI VFQ-25 total score and subscales (general vision, ocular pain, near 

activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, 

colour vision and peripheral vision). 

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

Beovu in all subsets of the paediatric population in neovascular AMD (see section 4.2 for information 

on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

Beovu is administered directly into the vitreous to exert local effects in the eye. 

 

Absorption and distribution 

 

After intravitreal administration of 6 mg brolucizumab per eye to patients with nAMD, the geometirc 

mean Cmax of free brolucizumab in the plasma was 49.0 ng/ml (range: 8.97 to 548 ng/ml) and was 

attained in 1 day. 

 

Biotransformation and elimination 

 

Brolucizumab is a monoclonal antibody fragment and no metabolism studies have been conducted. As 

a single-chain antibody fragment, free brolucizumab is expected to undergo elimination through both 

target-mediated disposition via binding to free endogenous VEGF, passive renal elimination and 

metabolism via proteolysis. 

 

After intravitreal injections, brolucizumab was eliminated with an apparent systemic half-life of 

4.4 days. Concentrations were generally near or below the quantitation limit (<0.5 ng/ml) 

approximately 4 weeks after dosing in most patients. Brolucizumab did not accumulate in the serum 

when administered intravitreally every 4 weeks. 

 

Special populations 

 

Elderly 

There were no relevant differences in systemic pharmacokinetics following intravitreal injection in a 

study with 22 patients aged 65 to 74 years, 18 patients aged 75 to 84 years and 3 patients aged 

≥85 years. 



 

13 

 

Renal impairment 

The systemic pharmacokinetics of brolucizumab was evaluated in nAMD patients with normal renal 

function (≥90 ml/min [n=21]), with mild (60 to <90 ml/min [n=22]) or moderate (30 to <60 ml/min 

[n=7]) renal impairment. While the mean systemic clearance values for patients with mild or moderate 

renal impairment were generally lower than patients with normal renal function, no significant impact 

of mild and moderate renal impairment on the overall systemic exposure to brolucizumab was 

observed. No patients with severe (<30 ml/min) renal impairment were studied. 

 

Hepatic impairment 

Brolucizumab has not been studied in patients with hepatic impairment. Mild to severe hepatic 

impairment should have no impact on the overall systemic exposure to brolucizumab, because 

metabolism occurs via proteolysis and does not depend on hepatic function. 

 

5.3 Preclinical safety data 
 

No studies have been conducted on the carcinogenic or mutagenic potential of brolucizumab. 

 

No animal reproduction studies have been conducted. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Sodium citrate 

Sucrose 

Polysorbate 80 

Water for injections 

 

6.2 Incompatibilities 
 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products. 

 

6.3 Shelf life 
 

Pre-filled syringe: 2 years 

Vial: 2 years 

 

6.4 Special precautions for storage 

 

Pre-filled syringe 

 

Store in a refrigerator (2°C - 8°C). 
Do not freeze. 

Keep the pre-filled syringe in its sealed blister and in the outer carton in order to protect from light. 

Prior to use, the unopened blister may be kept at room temperature (below 25°C) for up to 24 hours. 

 

Vial 

 

Store in a refrigerator (2°C - 8°C). 
Do not freeze. 

Keep the vial in the outer carton in order to protect from light. 

Prior to use, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours. 

 



 

14 

6.5 Nature and contents of container 

 

Pre-filled syringe 

 

0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper 

and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip 

cap including a Luer lock adapter. The pre-filled syringe has a plunger rod and a purple finger grip, 

and is packed in a sealed blister. 

 

Pack size of 1 pre-filled syringe. 

 

Vial 

 

0.230 ml sterile solution in a glass vial with a coated rubber stopper sealed with an aluminium cap 

with a purple plastic flip-off disk. 

 

Pack size of 1 vial and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 μm). 

 

6.6 Special precautions for disposal and other handling 

 

Pre-filled syringe 

 

The pre-filled syringe contains more than the recommended dose of 6 mg. The extractable volume of 

the pre-filled syringe (0.165 ml) is not to be used in total. The excess volume should be expelled prior 

to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the 

air bubble along with the excess medicinal product, slowly push the plunger until the edge below the 

dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, 

i.e., 6 mg brolucizumab). 

 

The solution should be inspected visually upon removal from the refrigerator and prior to 

administration. If particulates or cloudiness are visible, the pre-filled syringe must not be used and 

appropriate replacement procedures followed. 

 

The pre-filled syringe is sterile and for single use only. Do not use if the packaging, or pre-filled 

syringe are damaged or expired. Detailed instructions for use are provided in the package leaflet. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

regulations. 

 

Vial 

 

The vial contains more than the recommended dose of 6 mg. The extractable volume of the vial 

(0.23 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting 

the entire volume of the vial could result in overdose. The injection dose must be set to the 0.05 ml 

dose mark, i.e. 6 mg brolucizumab. 

 

The solution should be inspected visually upon removal from the refrigerator and prior to 

administration. If particulates or cloudiness are visible, the vial must not be used, and appropriate 

replacement procedures must be followed. 

 

The content of the vial and the filter needle are sterile and for single use only. Do not use if the 

packaging, vial and/or filter needle are damaged or expired. Detailed instructions for use are provided 

in the package leaflet. 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 



 

15 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/19/1417/001-002 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

13 February 2020 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 

  

http://www.ema.europa.eu/


 

16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 

FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



 

17 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 

SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR 

BATCH RELEASE 
 

Name and address of the manufacturer(s) of the biological active substance(s) 

 

Sandoz GmbH 

Biochemiestrasse 10 

6250 Kundl 

Austria 

 

Name and address of the manufacturer(s) responsible for batch release 

 

S.A. Alcon-Couvreur N.V. 

Rijksweg 14 

2870 Puurs 

Belgium 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 

Characteristics, section 4.2). 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

 Periodic safety update reports (PSURs) 

 

The requirements for submission of PSURs for this medicinal product are set out in the list of 

Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 

and any subsequent updates published on the European medicines web-portal. 

 

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 

6 months following authorisation. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 Risk management plan (RMP) 

 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 

activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 

marketing authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

 

  



 

18 

 Additional risk minimisation measures 

 

Prior to launch in each Member State the MAH shall agree the final educational material with the 

National Competent Authority. 

 

The MAH shall ensure that, following discussions and agreements with the National Competent 

Authority in each Member State where Beovu is marketed, all ophthalmological clinics where Beovu 

is expected to be used are provided with a patient guide in written and audio format, including the 

following key elements: 

 What is neovascular (wet) age-related macular degeneration 

 What is Beovu, how does it work, how is it administered and what to expect from the treatment 

 What are the steps following treatment with Beovu 

 Description of the risks, including increased intraocular pressure, intraocular inflammation, 

retinal vasculitis and/or retinal vascular occlusion, retinal detachment & retinal tear and 

endophthalmitis, and their key signs and symptoms; signs and symptoms of immunogenicity 

 Recommendations for monitoring and required examinations: Following intravitreal injection: 

measurement of increased intraocular pressure and perfusion of the optic nerve 

 When and how to seek urgent attention from the health care provider 

 

  



 

19 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



 

20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
  



 

21 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON – PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Beovu 120 mg/ml solution for injection in pre-filled syringe 

brolucizumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each pre-filled syringe of 0.165 ml solution contains 19.8 mg brolucizmab (120 mg/ml). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains: sodium citrate, sucrose, polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1x 0.165 ml pre-filled syringe 

Delivers a single dose of 6 mg/0.05 ml. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Intravitreal use 

For single use only. 

After opening the sterile sealed blister, proceed under aseptic conditions. 

Set dose to 0.05 ml dose mark. 

Excess volume to be expelled prior to injection. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

22 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

Do not freeze. 

Keep the pre-filled syringe in its sealed blister and in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/19/1417/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted. 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 

  



 

23 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

PEEL-OFF LABEL AFFIXED TO INNER LID OF CARTON – PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Beovu 

 

 

2. EXPIRY DATE 

 

EXP 

 

 

3. BATCH NUMBER 

 

Lot 

 

  



 

24 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER FOIL – PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Beovu 120 mg/ml solution for injection in pre-filled syringe 

brolucizumab 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

0.165 ml 

  



 

25 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

LABEL – PRE-FILLED SYRINGE 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Beovu 120 mg/ml injection 

brolucizumab 

Intravitreal use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

19.8 mg/0.165 ml 

 

 

6. OTHER 

 

  



 

26 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON – VIAL 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Beovu 120 mg/ml solution for injection 

brolucizumab 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each vial of 0.23 ml solution contains 27.6 mg brolucizmab (120 mg/ml). 

 

 

3. LIST OF EXCIPIENTS 

 

Contains: sodium citrate, sucrose, polysorbate 80, water for injections. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Solution for injection 

 

1x 0.23 ml vial, 1 filter needle. 

Delivers a single dose of 6 mg/0.05 ml. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Intravitreal use 

For single use only. 

After opening the vial, proceed under aseptic conditions. 

Set dose to 0.05 ml. 

Excess volume to be expelled prior to injection. 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

 

 



 

27 

9. SPECIAL STORAGE CONDITIONS 

 

Store in a refrigerator. 

Do not freeze. 

Keep the vial in the outer carton in order to protect from light. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/19/1417/002 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted. 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN 

  



 

28 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

LABEL - VIAL 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Beovu 120 mg/ml injection 

brolucizumab 

Intravitreal use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

27.6 mg/0.23 ml 

 

 

6. OTHER 

 

  



 

29 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

30 

Package leaflet: Information for the patient 
 

Beovu 120 mg/ml solution for injection in pre-filled syringe 

brolucizumab 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you are given this medicine because it contains important 

information for you. 
- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor. 

- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What Beovu is and what it is used for 

2. What you need to know before you are given Beovu 

3. How Beovu is given 

4. Possible side effects 

5. How to store Beovu 

6. Contents of the pack and other information 

 

 

1. What Beovu is and what it is used for 

 

What Beovu is 

Beovu contains the active substance brolucizumab, which belongs to a group of medicines called 

antineovascularisation agents. Beovu is injected into the eye by your doctor to treat an eye disorder 

called neovascular (wet) age-related macular degeneration (AMD). 

 

 
 

What Beovu is used for 

Beovu is used to treat neovascular wet AMD in adults, which occurs when abnormal blood vessels 

form and grow underneath the macula. The macula, which is at the back of the eye, is responsible for 

clear vision. The abnormal blood vessels may leak fluid or blood into the eye and interfere with the 

macula’s function, resulting in decreased vision. 

 

How Beovu works 

A substance called vascular endothelial growth factor A (VEGF-A) causes the growth of blood vessels 

in the eye. By attaching to VEGF-A, Beovu blocks its effect and so reduces the growth of abnormal 

blood vessels in AMD, which in turn reduces the leakage of fluid or blood in the eye. 

 

Beovu may slow down disease progression and thereby maintain, or even improve, your vision. 

 

 

Abnormal blood vessels 

that leak fluid or blood 

into the macula 



 

31 

 

2. What you need to know before you are given Beovu 

 

You must not be given Beovu: 
- if you are allergic to brolucizumab or any of the other ingredients of this medicine (listed in 

section 6). 

- if you have an active or suspected infection in or around the eye. 

- if you have pain or redness in your eye (eye inflammation). 

If any of these applies to you, tell your doctor. You should not be given Beovu. 

 

Warnings and precautions 

Talk to your doctor before you are given Beovu if any of the following applies to you: 

- if you have glaucoma (an eye condition usually caused by high pressure in the eye). 

- if you have a history of seeing flashes of light or floaters (dark floating spots) and if you have a 

sudden increase in the size and number of floaters. 

- if you have had eye surgery in the last 4 weeks or if eye surgery is planned in the next four 

weeks. 

- if you have ever had any eye diseases or eye treatments. 

 

Tell your doctor immediately if you: 

- develop redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or 

decreased vision, an increased number of small particles in your vision, increased sensitivity to 

light. 

- develop sudden vision loss, which could be a sign of retinal vascular occlusion. 

 

Furthermore it is important for you to know that: 

- the safety and efficacy of Beovu when administered to both eyes at the same time has not been 

studied and use in this way may lead to an increased risk of experiencing side effects. 

- injections with Beovu may cause an increase in eye pressure (intraocular pressure) in some 

patients within 30 minutes of the injection. Your doctor will monitor this after each injection. 

- your doctor will check whether you have other risk factors that may increase the chance of a 

tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and 

retinal pigment epithelial detachment or tear), in which case Beovu must be given with caution. 

 

The systemic use of VEGF inhibitors, substances similar to those contained in Beovu, is potentially 

related to the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may 

lead to heart attack or stroke. There is a theoretical risk of such events following injection of Beovu 

into the eye. 

 

Children and adolescents 

Beovu is not used in children and adolescents, because wet AMD occurs only in adults. 

 

Other medicines and Beovu 
Tell your doctor if you are using, have recently used or might use any other medicines. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, 

ask your doctor for advice before this medicine is given to you. 

 

Breast-feeding is not recommended during treatment with Beovu and for at least one month after 

stopping treatment with Beovu because it is not known whether Beovu passes into human milk. 

 

Women who could become pregnant must use an effective method of birth control during treatment 

and for at least one month after stopping treatment with Beovu. If you become pregnant or think you 

are pregnant during treatment, tell your doctor right away. 

 



 

32 

Driving and using machines 

After your injection with Beovu, you may have temporary vision problems (for example blurred 

vision). Do not drive or use machines as long as these last. 

 

Beovu contains sodium 

The medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 

“sodium-free”. 

 

 

3. How Beovu is given 
 

How much and how often Beovu is given 

The recommended dose is 6 mg brolucizumab. 

 

- You will be treated with one injection every month for the first 3 months. 

- After that, you may get one injection every 3 months. Your doctor will determine your 

treatment interval based on the condition of your eye; some patients may need treatment every 

2 months. 

 

 

 

 

 

 

 

 

 

 

 

Method of administration 

Beovu is given as an injection into your eye (intravitreal use) by an eye doctor. 

 

Before the injection, your doctor will clean your eye carefully, to prevent infection. Your doctor will 

also give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the 

injection. 

 

How long does Beovu treatment last for 

Wet AMD is a chronic disease and it therefore needs long-term treatment with this medicine, possibly 

continuing for months or years. Your doctor will check that the treatment is working during your 

regular scheduled visits. Your doctor may also check on your eyes between injections. If you have 

questions about how long you will receive Beovu, talk to your doctor. 

 

Before stopping Beovu treatment 

Speak with your doctor before stopping treatment. Stopping treatment may increase your risk of vision 

loss and your vision may worsen. 

 

If you have any further questions on the use of this medicine, ask your doctor. 

 

 

  

   For the first                                          Then, 

      3 months 

1 injection 

per month 

1 injection 

every 3 months or as 

recommended by your doctor 



 

33 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side 

effects with Beovu injection are either from the medicine itself or from the injection procedure and 

they mostly affect the eye. 

 

Some side effects could be serious 

Get immediate medical help if you have any of the following, which are signs of allergic reactions, 

inflammations or infections: 

 a sudden decrease or change in vision 

 pain, increased discomfort, worsening eye redness 

 

If you have any serious side effects, tell your doctor immediately. 

 

Other possible side effects 
Other side effects which may occur after Beovu treatment include those listed below. 

 

Most of the side effects are mild to moderate and will generally disappear within a week after each 

injection. 

 

If these side effects become severe, please tell your doctor. 

 

Common: may affect up to 1 in every 10 people 

 inflammation of the middle layer of the eye wall (uveitis) 

 detachment of the gel-like substance inside the eye (vitreous detachment) 

 tearing of the retina (the part at the back of the eye that detects light) or one of its layers (retinal 

pigment epithelial tear) 

 reduced sharpness of vision (reduced visual acuity) 

 bleeding in the retina (retinal haemorrhage) 

 inflammation of the iris, the coloured part of the eye (iritis) 

 clouding of the lens of the eye (cataract) 

 bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage) 

 moving spots in your vision (vitreous floaters) 

 eye pain 

 increase in pressure inside the eye (intraocular pressure increase) 

 redness in the white of the eye (conjunctivitis) 

 blurred or unclear vision 

 scratched cornea, damage to the clear layer of the eyeball that covers the iris (corneal abrasion) 

 damage to the clear layer of the eyeball that covers the iris (punctuate keratitis) 

 allergic reactions (hypersensitivity) 

 

Uncommon: may affect up to 1 in every 100 people 

 severe inflammation inside the eye (endophthalmitis) 

 blindness 

 sudden vision loss due to blockage of an artery in the eye (retinal artery occlusion) 

 detachment of the retina (retinal detachment) 

 redness of the eye (conjunctival hyperaemia) 

 increased tear production (lacrimation increased) 

 abnormal feeling in the eye 

 detachment of one of the layers of the retina (detachment of retinal pigment epithelium) 

 inflammation of the gel-like substance inside the eye (vitritis) 

 inflammation of the front of the eye (anterior chamber inflammation or flare) 

 inflammation in the iris and its adjacent tissue in the eye (iridocyclitis) 

 swelling of the cornea, the clear layer of the eyeball (corneal oedema) 

 bleeding in the eye (vitreous haemorrhage) 



 

34 

 

Not known: frequency cannot be estimated from the available data 

 sudden vision loss due to blockage of blood vessels in the back of the eye (retinal vascular 

occlusion) 

 inflammation of blood vessels in the back of the eye (retinal vasculitis) 

 

Reporting of side effects 

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 

By reporting side effects you can help provide more information on the safety of this medicine. 

 

 

5. How to store Beovu 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The 

expiry date refers to the last day of that month. 

 

Store in a refrigerator (2°C - 8°C). 

 

Do not freeze. 

 

Keep the pre-filled syringe in the sealed blister and in the outer carton in order to protect from light. 

 

Prior to use, the unopened blister with the pre-filled syringe may be kept at room temperature (below 

25°C) for up to 24 hours. 

 

 

6. Contents of the pack and other information 

 

What Beovu contains 

- The active substance is brolucizumab. One ml solution for injection contains 120 mg 

brolucizumab. Each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml solution. This 

provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of 

brolucizumab. 

- The other ingredients are: sodium citrate, sucrose, polysorbate 80, water for injections. 

 

What Beovu looks like and contents of the pack 

Beovu 120 mg/ml solution for injection in a pre-filled syringe (injection) is a clear to slightly 

opalescent, colourless to slightly brownish-yellow aqueous solution. 

 

Pack size of 1 pre-filled syringe for single use only. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 
S.A. ALCON-COUVREUR N.V. 

Rijksweg 14 

2870 Puurs 

Belgium 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

35 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 
Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 



 

36 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 
 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 



 

37 

The following information is intended for healthcare professionals only: 

 

Instruction for use of pre-filled syringe 

 

Storage and inspection 

 

 

Store Beovu in the refrigerator (2°C - 8°C). Do not freeze. Keep the 

pre-filled syringe in its sealed blister and the outer carton in order to 

protect from light. 

 

Prior to use, the unopened blister with the pre-filled syringe of Beovu 

may be kept at room temperature (below 25°C) for up to 24 hours. 

Make sure that your pack contains a sterile pre-filled syringe in a 

sealed blister. After opening the blister pack, proceed under aseptic 

conditions. 

 

Beovu is a clear to slightly opalescent and colourless to slightly 

brownish-yellow aqueous solution. 

 

The solution should be inspected visually upon removal from the 

refrigerator and prior to administration. If particulates or cloudiness 

are visible, the pre-filled syringe must not be used and appropriate 

replacement procedures followed. 

The pre-filled syringe is sterile and for single use only. Do not use if 

the packaging or pre-filled syringe are damaged or expired. 

 

How to prepare and administer Beovu 

 

The pre-filled syringe contains more than the recommended dose of 6 mg. The extractable volume of 

the pre-filled syringe (0.165 ml) is not to be used in total. The excess volume should be expelled prior 

to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. 

 

The intravitreal injection procedure must be carried out under aseptic conditions, which includes the 

use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or 

equivalent) and the availability of sterile paracentesis equipment (if required). 

 

Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid 

and ocular surface should be administered prior to the injection. 

 

For intravitreal injection, use a 30G x ½” sterile injection needle. The injection needle is not included 

in the Beovu pack. 

 

Ensure that the injection is given immediately after preparation of the dose (step 5). 

 

Note: The dose must be set to 0.05 ml. 
 



 

38 

 
 

Injection procedure 

 

1. Peel the lid off the syringe blister and, using aseptic 

technique, remove the syringe. 

2. 

 

Snap off (do not turn or twist) the syringe cap. 

3. Aseptically and firmly assemble a 30G x ½” injection needle 

onto the syringe. 

4. 

 

To check for air bubbles, hold the syringe with the needle 

pointing up. If there are any air bubbles, gently tap the syringe 

with your finger until the bubbles rise to the top. 

Carefully remove the needle cap by pulling it straight off. 

5. 

  

Hold the syringe at eye level and carefully push the plunger 

until the edge below the dome of the rubber stopper is aligned 

with the 0.05 ml dose mark. This will expel the air and the 

excess solution and set the dose to 0.05 ml. The syringe is 

ready for the injection. 

6. Inject slowly until the rubber stopper reaches the end of the 

syringe to deliver the volume of 0.05 ml. Confirm delivery of 

the full dose by checking that the rubber stopper has reached 

the end of the syringe barrel. 

 

Note: Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

Syringe cap Finger grip 

Luer lock 

0.05 ml dose mark 

Rubber stopper 
Plunger rod 



 

39 

 

Commonly asked questions and answers 

Q: What if I cannot remove all the air bubbles from the liquid? 

A: It is important that the liquid is air free. However, tiny air bubbles that are attached to the stopper 

usually do not detach from the stopper during the injection and therefore do not affect the dose 

volume. 

  



 

40 

Package leaflet: Information for the patient 
 

Beovu 120 mg/ml solution for injection 

brolucizumab 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you are given this medicine because it contains important 

information for you. 
- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor. 

- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What Beovu is and what it is used for 

2. What you need to know before you are given Beovu 

3. How Beovu is given 

4. Possible side effects 

5. How to store Beovu 

6. Contents of the pack and other information 

 

 

1. What Beovu is and what it is used for 

 

What Beovu is 

Beovu contains the active substance brolucizumab, which belongs to a group of medicines called 

antineovascularisation agents. Beovu is injected into the eye by your doctor to treat an eye disorder 

called neovascular (wet) age-related macular degeneration (AMD). 

 

 
 

What Beovu is used for 

Beovu is used to treat neovascular wet AMD in adults, which occurs when abnormal blood vessels 

form and grow underneath the macula. The macula, which is at the back of the eye, is responsible for 

clear vision. The abnormal blood vessels may leak fluid or blood into the eye and interfere with the 

macula’s function, resulting in decreased vision. 

 

How Beovu works 

A substance called vascular endothelial growth factor A (VEGF-A) causes the growth of blood vessels 

in the eye. By attaching to VEGF-A, Beovu blocks its effect and so reduces the growth of abnormal 

blood vessels in AMD, which in turn reduces the leakage of fluid or blood in the eye. 

 

Beovu may slow down disease progression and thereby maintain, or even improve, your vision. 

 

 

Abnormal blood vessels 

that leak fluid or blood 

into the macula 



 

41 

 

2. What you need to know before you are given Beovu 

 

You must not be given Beovu: 
- if you are allergic to brolucizumab or any of the other ingredients of this medicine (listed in 

section 6). 

- if you have an active or suspected infection in or around the eye. 

- if you have pain or redness in your eye (eye inflammation). 

If any of these applies to you, tell your doctor. You should not be given Beovu. 

 

Warnings and precautions 

Talk to your doctor before you are given Beovu if any of the following applies to you: 

- if you have glaucoma (an eye condition usually caused by high pressure in the eye). 

- if you have a history of seeing flashes of light or floaters (dark floating spots) and if you have a 

sudden increase in the size and number of floaters. 

- if you have had eye surgery in the last 4 weeks or if eye surgery is planned in the next four 

weeks. 

- if you have ever had any eye diseases or eye treatments. 

 

Tell your doctor immediately if you: 

- develop redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or 

decreased vision, an increased number of small particles in your vision, increased sensitivity to 

light. 

- develop sudden vision loss, which could be a sign of retinal vascular occlusion. 

 

Furthermore it is important for you to know that: 

- the safety and efficacy of Beovu when administered to both eyes at the same time has not been 

studied and use in this way may lead to an increased risk of experiencing side effects. 

- injections with Beovu may cause an increase in eye pressure (intraocular pressure) in some 

patients within 30 minutes of the injection. Your doctor will monitor this after each injection. 

- your doctor will check whether you have other risk factors that may increase the chance of a 

tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and 

retinal pigment epithelial detachment or tear), in which case Beovu must be given with caution. 

 

The systemic use of VEGF inhibitors, substances similar to those contained in Beovu, is potentially 

related to the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may 

lead to heart attack or stroke. There is a theoretical risk of such events following injection of Beovu 

into the eye. 

 

Children and adolescents 

Beovu is not used in children and adolescents, because wet AMD occurs only in adults. 

 

Other medicines and Beovu 
Tell your doctor if you are using, have recently used or might use any other medicines. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, 

ask your doctor for advice before this medicine is given to you. 

 

Breast-feeding is not recommended during treatment with Beovu and for at least one month after 

stopping treatment with Beovu because it is not known whether Beovu passes into human milk. 

 

Women who could become pregnant must use an effective method of birth control during treatment 

and for at least one month after stopping treatment with Beovu. If you become pregnant or think you 

are pregnant during treatment, tell your doctor right away. 

 



 

42 

Driving and using machines 

After your injection with Beovu, you may have temporary vision problems (for example blurred 

vision). Do not drive or use machines as long as these last. 

 

Beovu contains sodium 

The medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 

“sodium-free”. 

 

 

3. How Beovu is given 
 

How much and how often Beovu is given 

The recommended dose is 6 mg brolucizumab. 

 

- You will be treated with one injection every month for the first 3 months. 

- After that, you may get one injection every 3 months. Your doctor will determine your 

treatment interval based on the condition of your eye; some patients may need treatment every 

2 months. 

 

 

 

 

 

 

 

 

 

 

 

Method of administration 

Beovu is given as an injection into your eye (intravitreal use) by an eye doctor. 

 

Before the injection, your doctor will clean your eye carefully, to prevent infection. Your doctor will 

also give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the 

injection. 

 

How long does Beovu treatment last for 

Wet AMD is a chronic disease and it therefore needs long-term treatment with this medicine, possibly 

continuing for months or years. Your doctor will check that the treatment is working during your 

regular scheduled visits. Your doctor may also check on your eyes between injections. If you have 

questions about how long you will receive Beovu, talk to your doctor. 

 

Before stopping Beovu treatment 

Speak with your doctor before stopping treatment. Stopping treatment may increase your risk of vision 

loss and your vision may worsen. 

 

If you have any further questions on the use of this medicine, ask your doctor. 

 

 

  

   For the first                                          Then, 

      3 months 

1 injection 

per month 

1 injection 

every 3 months or as 

recommended by your doctor 



 

43 

4. Possible side effects 
 

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side 

effects with Beovu injection are either from the medicine itself or from the injection procedure and 

they mostly affect the eye. 

 

Some side effects could be serious 

Get immediate medical help if you have any of the following, which are signs of allergic reactions, 

inflammations or infections: 

 a sudden decrease or change in vision 

 pain, increased discomfort, worsening eye redness 

 

If you have any serious side effects, tell your doctor immediately. 

 

Other possible side effects 
Other side effects which may occur after Beovu treatment include those listed below. 

 

Most of the side effects are mild to moderate and will generally disappear within a week after each 

injection. 

 

If these side effects become severe, please tell your doctor. 

 

Common: may affect up to 1 in every 10 people 

 inflammation of the middle layer of the eye wall (uveitis) 

 detachment of the gel-like substance inside the eye (vitreous detachment) 

 tearing of the retina (the part at the back of the eye that detects light) or one of its layers (retinal 

pigment epithelial tear) 

 reduced sharpness of vision (reduced visual acuity) 

 bleeding in the retina (retinal haemorrhage) 

 inflammation of the iris, the coloured part of the eye (iritis) 

 clouding of the lens of the eye (cataract) 

 bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage) 

 moving spots in your vision (vitreous floaters) 

 eye pain 

 increase in pressure inside the eye (intraocular pressure increase) 

 redness in the white of the eye (conjunctivitis) 

 blurred or unclear vision 

 scratched cornea, damage to the clear layer of the eyeball that covers the iris (corneal abrasion) 

 damage to the clear layer of the eyeball that covers the iris (punctuate keratitis) 

 allergic reactions (hypersensitivity) 

 

Uncommon: may affect up to 1 in every 100 people 

 severe inflammation inside the eye (endophthalmitis) 

 blindness 

 sudden vision loss due to blockage of an artery in the eye (retinal artery occlusion) 

 detachment of the retina (retinal detachment) 

 redness of the eye (conjunctival hyperaemia) 

 increased tear production (lacrimation increased) 

 abnormal feeling in the eye 

 detachment of one of the layers of the retina (detachment of retinal pigment epithelium) 

 inflammation of the gel-like substance inside the eye (vitritis) 

 inflammation of the front of the eye (anterior chamber inflammation or flare) 

 inflammation in the iris and its adjacent tissue in the eye (iridocyclitis) 

 swelling of the cornea, the clear layer of the eyeball (corneal oedema) 

 bleeding in the eye (vitreous haemorrhage) 



 

44 

 

Not known: frequency cannot be estimated from the available data 

 sudden vision loss due to blockage of blood vessels in the back of the eye (retinal vascular 

occlusion) 

 inflammation of blood vessels in the back of the eye (retinal vasculitis) 

 

Reporting of side effects 

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 

By reporting side effects you can help provide more information on the safety of this medicine. 

 

 

5. How to store Beovu 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The 

expiry date refers to the last day of that month. 

 

Store in a refrigerator (2°C - 8°C). 

 

Do not freeze. 

 

Keep the vial in the outer carton in order to protect from light. 

 

Prior to use, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours. 

 

 

6. Contents of the pack and other information 

 

What Beovu contains 

- The active substance is brolucizumab. One ml solution for injection contains 120 mg 

brolucizumab.Each vial contains 27.6 mg brolucizumab in 0.23 ml solution. This provides a 

usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab. 

- The other ingredients are: sodium citrate, sucrose, polysorbate 80, water for injections. 

 

What Beovu looks like and contents of the pack 

Beovu 120 mg/ml solution for injection (injection) is a clear to slightly opalescent, colourless to 

slightly brownish-yellow aqueous solution. 

 

Pack size of 1 vial and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 μm) for single use only. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 
S.A. ALCON-COUVREUR N.V. 

Rijksweg 14 

2870 Puurs 

Belgium 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

45 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 

Novartis Pharma B.V. 

Tel: +31 88 04 52 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 

Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 



 

46 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 
 

This leaflet was last revised in 
 

 

Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 



 

47 

The following information is intended for healthcare professionals only: 

 

Instructions for use of vial 

 

Storage and inspection 

 

 

Store Beovu in the refrigerator (2°C - 8°C). Do not freeze. Keep the vial 

in the outer carton in order to protect from light. 

 

Prior to use, the unopened vial of Beovu may be kept at room 

temperature (below 25°C) for up to 24 hours. After opening the vial, 

proceed under aseptic conditions. 

 

Beovu is a clear to slightly opalescent and colourless to slightly 

brownish-yellow aqueous solution. 

 

The solution should be inspected visually upon removal from the 

refrigerator and prior to administration. If particulates or cloudiness are 

visible, the vial must not be used and appropriate replacement procedures 

followed. 

The contents of the vial and the filter needle are sterile and for single use 

only. Do not use if the packaging, vial and/or filter needle are damaged 

or expired. 

 

How to prepare and administer Beovu 

 

The vial contains more than the recommended dose of 6 mg. The extractable volume of the vial 

(0.23 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting 

the entire volume of the vial could result in overdose. 

 

The intravitreal injection procedure must be carried out under aseptic conditions, which includes the 

use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or 

equivalent) and the availability of sterile paracentesis equipment (if required). 

 

Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid 

and ocular surface should be administered prior to the injection. 

 

For preparation and intravitreal injection, the following single-use medical devices are needed: 

 A 30G x ½” injection needle, sterile. 

 A 1 ml syringe with a 0.05 ml dose mark, sterile. 

 The 5 μm blunt filter needle (18G x 1½”, 1.2 mm x 40 mm), sterile. 

 

The injection needle and the syringe are not included in the Beovu pack. 

 

Ensure that the injection is given immediately after preparation of the dose (step 8). 

 

Note: The dose must be set to 0.05 ml. 

 



 

48 

Injection procedure 

 

1. 

  

Remove the vial cap and clean the vial septum (e.g. with 

70% alcohol swab). 

2. Assemble the filter needle onto a 1 ml syringe using aseptic 

technique. 

3. Push the filter needle into the centre of the vial septum until 

the needle touches the bottom of the vial. 

 

4. 

  

To withdraw the liquid, hold the vial slightly inclined and 

slowly withdraw all the liquid from the vial and filter needle. 

Ensure that the plunger rod is drawn sufficiently back when 

emptying the vial in order to completely empty the filter 

needle. 

 

5. Disconnect the filter needle from the syringe in an aseptic 

manner and dispose of it. The filter needle is not to be used 

for intravitreal injection. 

 

6. Aseptically and firmly assemble a 30G x ½” injection needle 

onto the syringe. 

 

7. 

  

To check for air bubbles, hold the syringe with the needle 

pointing up. If there are any air bubbles, gently tap the 

syringe with your finger until the bubbles rise to the top. 

 



 

49 

8. 

  

Hold the syringe at eye level and carefully push the plunger 

to expel the air along with the excess solution from the 

syringe and adjust the dose to the 0.05 ml mark. The syringe 

is ready for the injection. 

 

9. Inject slowly until the rubber stopper reaches the end of the 

syringe to deliver the volume of 0.05 ml. Confirm delivery 

of the full dose by checking that the rubber stopper has 

reached the end of the syringe barrel. 

 

 

Note: Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

Commonly asked questions and answers 

Q: What if I have difficulty withdrawing sufficient liquid from the vial? 

A: Do not shake the vial before withdrawal but let the liquid settle to the bottom of the vial. Ensure the 

vial is in an upright, slightly inclined position. Slowly withdraw the plunger and wait for the liquid to 

appear in the syringe barrel. Continue to withdraw slowly to completely empty the vial and the filter 

needle. 

 

Q: What if I cannot remove all the air bubbles from the liquid? 

A: It is important that the liquid is air free. However, tiny air bubbles that are attached to the stopper 

usually do not detach from the stopper during the injection and therefore do not affect the dose 

volume. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what beovu is and what it is used for', 'Section_Content': "what beovu is beovu contains the active substance brolucizumab, which belongs to a group of medicines called antineovascularisation agents. beovu is injected into the eye by your doctor to treat an eye disorder called neovascular (wet) age-related macular degeneration (amd). what beovu is used for beovu is used to treat neovascular wet amd in adults, which occurs when abnormal blood vessels form and grow underneath the macula. the macula, which is at the back of the eye, is responsible for clear vision. the abnormal blood vessels may leak fluid or blood into the eye and interfere with the macula's function, resulting in decreased vision. how beovu works a substance called vascular endothelial growth factor a (vegf-a) causes the growth of blood vessels in the eye. by attaching to vegf-a, beovu blocks its effect and so reduces the growth of abnormal blood vessels in amd, which in turn reduces the leakage of fluid or blood in the eye. beovu may slow down disease progression and thereby maintain, or even improve, your vision. abnormal blood vessels that leak fluid or blood into the macula 31", 'Entity_Recognition': [{'Text': 'beovu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 16, 'BeginOffset': 50, 'EndOffset': 62, 'Score': 0.8224484324455261, 'Text': 'brolucizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a group of medicines', 'Type': 'TREATMENT', 'BeginOffset': 81, 'EndOffset': 101}, {'Text': 'antineovascularisation agents', 'Type': 'TREATMENT', 'BeginOffset': 109, 'EndOffset': 138}, {'Id': 0, 'BeginOffset': 167, 'EndOffset': 170, 'Score': 0.810910165309906, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'an eye disorder', 'Type': 'PROBLEM', 'BeginOffset': 195, 'EndOffset': 210}, {'Text': 'neovascular (wet) age', 'Type': 'PROBLEM', 'BeginOffset': 218, 'EndOffset': 239}, {'Id': 19, 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{'Title': '2. what you need to know before you are given beovu', 'Section_Content': 'you must not be given beovu: - if you are allergic to brolucizumab or any of the other ingredients of this medicine (listed in section 6). - if you have an active or suspected infection in or around the eye. - if you have pain or redness in your eye (eye inflammation). if any of these applies to you, tell your doctor. you should not be given beovu. warnings and precautions talk to your doctor before you are given beovu if any of the following applies to you: - if you have glaucoma (an eye condition usually caused by high pressure in the eye). - if you have a history of seeing flashes of light or floaters (dark floating spots) and if you have a sudden increase in the size and number of floaters. - if you have had eye surgery in the last 4 weeks or if eye surgery is planned in the next four weeks. - if you have ever had any eye diseases or eye treatments. tell your doctor immediately if you: - develop redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision, increased sensitivity to light. - develop sudden vision loss, which could be a sign of retinal vascular occlusion. furthermore it is important for you to know that: - the safety and efficacy of beovu when administered to both eyes at the same time has not been studied and use in this way may lead to an increased risk of experiencing side effects. - injections with beovu may cause an increase in eye pressure (intraocular pressure) in some patients within 30 minutes of the injection. your doctor will monitor this after each injection. - your doctor will check whether you have other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment or tear), in which case beovu must be given with caution. the systemic use of vegf inhibitors, substances similar to those contained in beovu, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. there is a theoretical risk of such events following injection of beovu into the eye. children and adolescents beovu is not used in children and adolescents, because wet amd occurs only in adults. other medicines and beovu tell your doctor if you are using, have recently used or might use any other medicines. pregnancy and breast-feeding if you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you. breast-feeding is not recommended during treatment with beovu and for at least one month after stopping treatment with beovu because it is not known whether beovu passes into human milk. women who could become pregnant must use an effective method of birth control during treatment and for at least one month after stopping treatment with beovu. if you become pregnant or think you are pregnant during treatment, tell your doctor right away. driving and using machines after your injection with beovu, you may have temporary vision problems (for example blurred vision). do not drive or use machines as long as these last. beovu contains sodium the medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free".', 'Entity_Recognition': [{'Text': 'beovu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 42, 'EndOffset': 50}, {'Id': 18, 'BeginOffset': 54, 'EndOffset': 66, 'Score': 0.8939749002456665, 'Text': 'brolucizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 102, 'EndOffset': 115}, {'Text': 'an active or suspected infection', 'Type': 'PROBLEM', 'BeginOffset': 153, 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{'Title': '3. how beovu is given', 'Section_Content': 'how much and how often beovu is given the recommended dose is 6 mg brolucizumab. - you will be treated with one injection every month for the first 3 months. - after that, you may get one injection every 3 months. your doctor will determine your treatment interval based on the condition of your eye; some patients may need treatment every 2 months. method of administration beovu is given as an injection into your eye (intravitreal use) by an eye doctor. before the injection, your doctor will clean your eye carefully, to prevent infection. your doctor will also give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the injection. how long does beovu treatment last for wet amd is a chronic disease and it therefore needs long-term treatment with this medicine, possibly continuing for months or years. your doctor will check that the treatment is working during your regular scheduled visits. your doctor may also check on your eyes between injections. if you have questions about how long you will receive beovu, talk to your doctor. before stopping beovu treatment speak with your doctor before stopping treatment. stopping treatment may increase your risk of vision loss and your vision may worsen. if you have any further questions on the use of this medicine, ask your doctor. for the first then, 3 months 1 injection per month 1 injection every 3 months or as recommended by your doctor 33', 'Entity_Recognition': [{'Text': 'beovu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 62, 'EndOffset': 63}, {'Id': 8, 'BeginOffset': 67, 'EndOffset': 79, 'Score': 0.9982324242591858, 'Text': 'brolucizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9651308059692383, 'RelationshipScore': 0.9999895095825195, 'RelationshipType': 'DOSAGE', 'Id': 7, 'BeginOffset': 62, 'EndOffset': 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. the side effects with beovu injection are either from the medicine itself or from the injection procedure and they mostly affect the eye. some side effects could be serious get immediate medical help if you have any of the following, which are signs of allergic reactions, inflammations or infections: a sudden decrease or change in vision pain, increased discomfort, worsening eye redness if you have any serious side effects, tell your doctor immediately. other possible side effects other side effects which may occur after beovu treatment include those listed below. most of the side effects are mild to moderate and will generally disappear within a week after each injection. if these side effects become severe, please tell your doctor. common: may affect up to 1 in every 10 people inflammation of the middle layer of the eye wall (uveitis) detachment of the gel-like substance inside the eye (vitreous detachment) tearing of the retina (the part at the back of the eye that detects light) or one of its layers (retinal pigment epithelial tear) reduced sharpness of vision (reduced visual acuity) bleeding in the retina (retinal haemorrhage) inflammation of the iris, the coloured part of the eye (iritis) clouding of the lens of the eye (cataract) bleeding from small blood vessels in the outer layer of the eye (conjunctival haemorrhage) moving spots in your vision (vitreous floaters) eye pain increase in pressure inside the eye (intraocular pressure increase) redness in the white of the eye (conjunctivitis) blurred or unclear vision scratched cornea, damage to the clear layer of the eyeball that covers the iris (corneal abrasion) damage to the clear layer of the eyeball that covers the iris (punctuate keratitis) allergic reactions (hypersensitivity) uncommon: may affect up to 1 in every 100 people severe inflammation inside the eye (endophthalmitis) blindness sudden vision loss due to blockage of an artery in the eye (retinal artery occlusion) detachment of the retina (retinal detachment) redness of the eye (conjunctival hyperaemia) increased tear production (lacrimation increased) abnormal feeling in the eye detachment of one of the layers of the retina (detachment of retinal pigment epithelium) inflammation of the gel-like substance inside the eye (vitritis) inflammation of the front of the eye (anterior chamber inflammation or flare) inflammation in the iris and its adjacent tissue in the eye (iridocyclitis) swelling of the cornea, the clear layer of the eyeball (corneal oedema) bleeding in the eye (vitreous haemorrhage) 34 not known: frequency cannot be estimated from the available data sudden vision loss due to blockage of blood vessels in the back of the eye (retinal vascular occlusion) inflammation of blood vessels in the back of the eye (retinal vasculitis) reporting of side effects if you get any 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{'Title': '5. how to store beovu', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton and label after exp. the expiry date refers to the last day of that month. store in a refrigerator (2 - 8). do not freeze. keep the pre-filled syringe in the sealed blister and in the outer carton in order to protect from light. prior to use, the unopened blister with the pre-filled syringe may be kept at room temperature (below 25) for up to 24 hours.', 'Entity_Recognition': [{'Text': 'beovu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 70, 'EndOffset': 83}, {'Text': 'the pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 264, 'EndOffset': 286}, {'Text': 'the sealed blister', 'Type': 'TREATMENT', 'BeginOffset': 290, 'EndOffset': 308}, {'Text': 'the outer carton', 'Type': 'TREATMENT', 'BeginOffset': 316, 'EndOffset': 332}, {'Text': 'the unopened blister', 'Type': 'PROBLEM', 'BeginOffset': 379, 'EndOffset': 399}, {'Text': 'the pre-filled syringe', 'Type': 'TREATMENT', 'BeginOffset': 405, 'EndOffset': 427}, {'Text': '25', 'Type': 'NUMBER', 'BeginOffset': 467, 'EndOffset': 469}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 481, 'EndOffset': 483}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what beovu contains - the active substance is brolucizumab. one ml solution for injection contains 120 mg brolucizumab. each pre-filled syringe contains 19.8 mg brolucizumab in 0.165 ml solution. this provides a usable amount to deliver a single dose of 0.05 ml solution containing 6 mg of brolucizumab. - the other ingredients are: sodium citrate, sucrose, polysorbate 80, water for injections. what beovu looks like and contents of the pack beovu 120 mg/ml solution for injection in a pre-filled syringe (injection) is a clear to slightly opalescent, colourless to slightly brownish-yellow aqueous solution. pack size of 1 pre-filled syringe for single use only.', 'Entity_Recognition': [{'Text': 'beovu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 46, 'EndOffset': 58, 'Score': 0.9897342920303345, 'Text': 'brolucizumab', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 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