Brolucizumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 7, 2026🚩 Report this page

Brolucizumab

Antineovascularisation Agents

Sold as BEOVU

CA Health CanadaGB MHRAEU EMA

Drug class: Antineovascularisation Agents
Availability: See label
Routes: Intravitreal
Markets covered: 3
Products on record: 5

Overview

Brolucizumab is an active pharmaceutical ingredient in the Antineovascularisation Agents group (S01LA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	2	March 19, 2026
GB United Kingdom	MHRA	2	February 27, 2026
EU European Union	EMA	1	May 7, 2026

CACanada· Health Canada

2 products

Uses

CAOfficial regulatory label· revised March 19, 2026[1]

BEOVU® (brolucizumab injection) is indicated for: • The treatment of neovascular (wet) age-related macular degeneration (AMD). • The treatment of diabetic macular edema (DME). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Recommended Dose and Dosage Adjustment, Special Populations).

How to take

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised February 27, 2026[2]

1).

How to take

GBOfficial regulatory label· revised February 27, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 7, 2026[3]

1). 3

How to take

EUOfficial regulatory label· revised May 7, 2026

Sources & citations

[1]Health Canada (DPD) · 02496976 · revised March 19, 2026
[2]MHRA (UK) · PLGB001011211 · revised February 27, 2026
[3]European Medicines Agency · EMEA/H/C/004913 · revised May 7, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

1 Dosing Considerations • Single-use pre-filled syringe or single-use vial* for intravitreal injection only. • Each pre-filled syringe or vial should only be used for the treatment of a single eye. • Beovu must be administered by a qualified physician experienced in administering intravitreal injections.
• The safety and efficacy of Beovu administered in both eyes concurrently have not been studied. 05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first three doses. Thereafter, the physician may modify 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 and assessed regularly after that. In patients without disease activity, treatment up to every 12 weeks (3 months) could be considered. 1 Clinical Trials by Indication, Treatment of wet AMD); however, the interval between two doses should not be less than every 8 weeks (2 months) (see 7 WARNINGS AND PRECAUTIONS).
05 mL) administered by intravitreal injection every 6 weeks for the first five doses. Thereafter, the physician may modify treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. In patients without disease activity, treatment up to every 12 weeks (3 months) could be considered.
1 Clinical Trials by Indication, Treatment of DME); however, the interval between two doses should not be less than every 8 weeks (2 months) (see 7 WARNINGS AND PRECAUTIONS). Special populations Renal impairment (see 10 CLINICAL PHARMACOLOGY).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment (see 10 CLINICAL PHARMACOLOGY). Pediatric patients (below 18 years) The safety and efficacy of Beovu in pediatric patients have not been established.
No data are available to Health Canada. Geriatrics (65 years or above) In the HAWK and HARRIER clinical studies, approximately 90% (978/1088) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 60% (648/1088) were ≥ 75 years of age.
In the KESTREL and KITE clinical studies, approximately 45% (164/368) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 10% (37/368) were ≥ 75 years of age. No dosage regimen adjustment is required for geriatric use (see 10 CLINICAL PHARMACOLOGY).
4 Administration As with all medicinal products for intravitreal use, Beovu should be inspected visually prior to administration (see 12 SPECIAL HANDLING INSTRUCTIONS). The injection procedure must be carried out under aseptic conditions, which include 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. Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
Patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see 2 CONTRAINDICATIONS). 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. g. eye pain, redness of the eye, photophobia, blurring of vision) without delay. For information on preparation of Beovu, see Instructions for use below.
0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the center of the globe. 05 mL is then delivered slowly; a different scleral site should be used for subsequent injections. Instruction for use of the Beovu pre-filled syringe Storage and inspection Store Beovu in the refrigerator (2°C to 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 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 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 anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should […]

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 19, 2026[1]

). Proper aseptic injection techniques must always be used when administering Beovu. Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion Intraocular inflammation (IOI), including retinal vasculitis and/or retinal vascular occlusion, have been reported with the use of Beovu.
These immune mediated adverse events may occur following the first intravitreal injection and at any time of treatment. These events were observed more frequently at the beginning of the treatment. Discontinue treatment with Beovu in patients who develop these events.
Patients treated with Beovu who experience IOI may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored (see 2 CONTRAINDICATIONS and 8 ADVERSE REACTIONS). Patients treated with Beovu with a medical history of intraocular inflammation and/or retinal vascular occlusion (within 12 months prior to the first brolucizumab injection) should be closely monitored, since they are at increased risk of developing retinal vasculitis and/or retinal vascular occlusion.
Based on clinical studies, intraocular inflammation related adverse events, including retinal vasculitis and retinal vascular occlusion, were reported more frequently in female patients treated with Beovu than in male patients (see 8 ADVERSE REACTIONS).
2 Recommended Dose and Dosage Adjustment). 0%). The incidences of IOI and retinal vascular occlusion were also higher than what was previously observed in patients who received Beovu every 8 or 12 week maintenance dosing in the pivotal Phase III clinical studies (HAWK and HARRIER).
Patients should be instructed to report any symptoms suggestive of the above mentioned events without delay and should be managed appropriately. PrBEOVU® (brolucizumab injection) Page 12 of 35 Increase in Intraocular Pressure Transient increases in intraocular pressure have been seen within 30 minutes of intravitreal injection with VEGF inhibitors, including Beovu.
Sustained intraocular pressure increases have also been reported (see 8 ADVERSE REACTIONS). Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately. Beovu has not been studied in patients with poorly controlled glaucoma.
Do not inject Beovu while the intraocular pressure is ≥30 mmHg.
Reproductive Health:
Female and Male Potential Females of reproductive potential should use effective contraception (methods that result in less than 1 % pregnancy rates) during treatment with Beovu and for at least one month after the last dose when stopping treatment with Beovu.
• Fertility and Teratogenic Risk In an enhanced pre- and postnatal development (ePPND) study in pregnant cynomolgus monkeys, brolucizumab was administered to all animals by intravitreal (IVT) injection to one eye at doses of 3 or 6 mg once every 4 weeks until delivery.
One additional injection was administered to a subset of animals 28 days post-partum and had blood and milk collected for toxicokinetic evaluations. Second trimester-pregnancy fetal losses were observed in the 6 mg/eye group (10-fold the maximum recommended human dose [MRHD] on a mg/kg basis).
Fetal loss was not observed in the 3 mg/eye group. Bilateral absent metatarsal and absent distal tail were observed in a single stillborn infant at 6 mg/eye. The animal appeared to be partially cannibalized, however developmental malformation could not be ruled out.
VEGF inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility. Based on the mechanism of action of VEGF inhibitors, there is a potential risk to female reproduction and to embryo-fetal development.
Systemic effects following intravitreal use Thromboembolic Events and Non-ocular Hemorrhages There is a potential risk of arterial thromboembolic events (ATEs) and non-ocular hemorrhage following intravitreal use of VEGF inhibitors, including Beovu (see 8 ADVERSE REACTIONS).
ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). There are limited data on safety in the treatment of patients with AMD with a history of stroke, transient ischemic attacks or myocardial infarction within the last 3-6 months.
1 Pregnant Women There are no adequate and well-controlled studies of Beovu administration in pregnant women. The potential risk of use of Beovu in pregnancy is unknown. A study in pregnant cynomolgus monkeys showed fetal losses and a bilateral absent metatarsal in a single offspring at 10-fold MRHD on a mg/kg basis (see Fertility).
PrBEOVU® (brolucizumab injection) Page 13 of 35 Based on the anti-VEGF mechanism of action, brolucizumab must be regarded as potentially teratogenic and embryo-/fetotoxic. Therefore, Beovu should not be used during pregnancy unless the potential benefits outweigh the potential risks to the fetus.
2 Breast-feeding It is unknown if brolucizumab is transferred into human milk after administration of Beovu. There are no data on the effects of Beovu on the breastfed child or on milk production. Because of the potential for adverse drug reactions in the breastfed child, breastfeeding is not recommended during treatment with Beovu and for at least one month after the last dose when stopping treatment with Beovu.
3 […]

CAOfficial regulatory label· Warnings and precautions· revised March 19, 2026[1]

). 05 mL) administered by intravitreal injection every 6 weeks for the first five doses. Thereafter, the physician may modify treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. In patients without disease activity, treatment up to every 12 weeks (3 months) could be considered.
1 Clinical Trials by Indication, Treatment of DME); however, the interval between two doses should not be less than every 8 weeks (2 months) (see 7 WARNINGS AND PRECAUTIONS). Special populations Renal impairment (see 10 CLINICAL PHARMACOLOGY).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment (see 10 CLINICAL PHARMACOLOGY). Pediatric patients (below 18 years) The safety and efficacy of Beovu in pediatric patients have not been established.
No data are available to Health Canada. Geriatrics (65 years or above) In the HAWK and HARRIER clinical studies, approximately 90% (978/1088) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 60% (648/1088) were ≥ 75 years of age.
In the KESTREL and KITE clinical studies, approximately 45% (164/368) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 10% (37/368) were ≥ 75 years of age. No dosage regimen adjustment is required for geriatric use (see 10 CLINICAL PHARMACOLOGY).
4 Administration As with all medicinal products for intravitreal use, Beovu should be inspected visually prior to administration (see 12 SPECIAL HANDLING INSTRUCTIONS). The injection procedure must be carried out under aseptic conditions, which include 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. Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
Patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see 2 CONTRAINDICATIONS). Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.

This is not medical advice. Consult a qualified healthcare professional.

Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections. 05 ml solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses.. A disease activity assessment is suggested 16 weeks (4 months) after treatment start.
05 ml solution) may be administered every 6 weeks for the first 2 doses. A disease activity assessment is suggested 12 weeks (3 months) after treatment start. A third dose may be administered based on disease activity as assessed by visual acuity and/or anatomical parameters at week 12.
Maintenance treatment After the last loading dose, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. 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. If patients are being treated according to a treat-and-extend regimen and there are no signs of disease activity, the treatment intervals could be extended stepwise until signs of disease activity recur.
1). There are limited data on treatment intervals longer than 20 weeks (5 months). 4). If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. 05 ml solution) administered by intravitreal injection every 6 weeks for the first 5 doses.
Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. 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. 1). If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. 2). 2).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment. 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. 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. 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.
0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. 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. g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
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. 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. e. 6 mg brolucizumab).

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised February 27, 2026[2]

Summary of the safety profile Wet AMD For wet AMD, a total of 1 088 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 730 patients were treated with the recommended dose of 6 mg.
1%). 7%). DME For DME, a total of 558 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 368 patients were treated with the recommended dose of 6 mg. 4%). 5%). Tabulated list of adverse reactions The adverse reactions experienced following administration of Beovu in clinical studies are summarised in Table 1 below.
Adverse reactions (Table 1) are listed according to the MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories for each adverse reaction are based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 Frequencies of adverse reactions in clinical studies MedDRA System organ class Frequency category* Immune system disorders Hypersensitivity (including urticaria, rash, pruritus, erythema) Common Eye disorders Visual acuity reduced Common Retinal haemorrhage Common Uveitis Common Iridocyclitis Common Iritis Common Retinal vascular occlusion Common Vitreous haemorrhage 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 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 Anterior chamber flare Uncommon Corneal oedema Uncommon Retinal vasculitis Uncommon Scleritis** Uncommon *The frequency category for each adverse reaction is based on the most conservative incidence rate from either pooled nAMD or pooled DME Phase III pivotal studies.
**including episcleritis Description of selected adverse reactions Immunogenicity There is a potential for an immune response in patients treated with Beovu. Wet AMD After dosing with Beovu for 88 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 23–25% of patients.
DME After dosing with Beovu for 96 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 16-23% of patients. Among AMD and DME patients with treatment-emergent antibodies, a higher number of intraocular inflammation adverse reactions were observed.
4). 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 and DME. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised February 27, 2026[2]

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. 8). Proper aseptic injection techniques must always be used when administering Beovu.
Patients should be instructed to report any symptoms suggestive of the above- mentioned events without delay. 8). A higher number of intraocular inflammation events were observed among patients with treatment-emergent antibodies. After investigation, retinal vasculitis and/or retinal vascular occlusion were found to be immune-mediated events.
Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, may occur following the first intravitreal injection and at any time of treatment. These events were observed more frequently at the beginning of the treatment.
g. 3% females vs. 2% males in HAWK and HARRIER) and in Japanese patients. In patients developing these events, treatment with Beovu should be discontinued and the events should be promptly managed. Patients treated with Beovu with a medical history of intraocular inflammation and/or retinal vascular occlusion (within 12 months prior to the first brolucizumab injection) should be closely monitored, since they are at increased risk of developing retinal vasculitis and/or retinal vascular occlusion.
The interval between two Beovu doses during maintenance treatment should not be less than 8 weeks considering that a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion was reported in patients with nAMD who received Beovu every 4 week maintenance dosing in a clinical study compared to patients who received Beovu every 8 or 12 week maintenance dosing in the pivotal Phase III clinical studies.
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. 8). 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.

This is not medical advice. Consult a qualified healthcare professional.

Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections. 05 ml solution), administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. A disease activity assessment is suggested 16 weeks (4 months) after treatment start.
05 ml solution) may be administered every 6 weeks for the first 2 doses. A disease activity assessment is suggested 12 weeks (3 months) after treatment start. A third dose may be administered based on disease activity as assessed by visual acuity and/or anatomical parameters at week 12.
Maintenance treatment After the last loading dose, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. 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. If patients are being treated according to a treat-and- extend regimen and there are no signs of disease activity, the treatment intervals could be extended stepwise until signs of disease activity recur.
1). There are limited data on treatment intervals longer than 20 weeks (5 months). 4). If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. 05 ml solution) administered by intravitreal injection every 6 weeks for the first 5 doses.
Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. 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. 1). If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. 2). 2).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment. 2). 4 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. 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. 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.
0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. 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. g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
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. 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. 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. 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. e. 6 mg brolucizumab). 6. 5

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 7, 2026[3]

Summary of the safety profile Wet AMD For wet AMD, a total of 1 088 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 730 patients were treated with the recommended dose of 6 mg.
1%). 7%). DME For DME, a total of 558 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 368 patients were treated with the recommended dose of 6 mg. 4%). 5%). Tabulated list of adverse reactions The adverse reactions experienced following administration of Beovu in clinical studies are summarised in Table 1 below.
Adverse reactions (Table 1) are listed according to the MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories for each adverse reaction are based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 Frequencies of adverse reactions in clinical studies MedDRA System organ class Frequency category* Immune system disorders Hypersensitivity (including urticaria, rash, pruritus, erythema) Common Eye disorders Visual acuity reduced Common Retinal haemorrhage Common Uveitis Common Iridocyclitis Common Iritis Common Retinal vascular occlusion Common Vitreous haemorrhage Common Vitreous detachment Common Retinal tear Common Cataract Common Conjunctival haemorrhage Common Vitreous floaters Common Eye pain Common 9 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 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 Anterior chamber flare Uncommon Corneal oedema Uncommon Retinal vasculitis Uncommon Scleritis** Uncommon *The frequency category for each adverse reaction is based on the most conservative incidence rate from either pooled nAMD or pooled DME Phase III pivotal studies.
**including episcleritis Description of selected adverse reactions Immunogenicity There is a potential for an immune response in patients treated with Beovu. Wet AMD After dosing with Beovu for 88 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 23–25% of patients.
DME After dosing with Beovu for 96 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 16-23% of patients. Among AMD and DME patients with treatment-emergent antibodies, a higher number of intraocular inflammation adverse reactions were observed.
4). 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 and DME. 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.
10

EUOfficial regulatory label· Warnings and precautions· revised May 7, 2026[3]

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. 8). Proper aseptic injection techniques must always be used when administering Beovu.
Patients should be instructed to report any symptoms suggestive of the above-mentioned events without delay. 8). A higher number of intraocular inflammation events were observed among patients with treatment-emergent antibodies. After investigation, retinal vasculitis and/or retinal vascular occlusion were found to be immune-mediated events.
Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, may occur following the first intravitreal injection and at any time of treatment. These events were observed more frequently at the beginning of the treatment.
g. 3% females vs. 2% males in HAWK and HARRIER) and in Japanese patients. In patients developing these events, treatment with Beovu should be discontinued and the events should be promptly managed. Patients treated with Beovu with a medical history of intraocular inflammation and/or retinal vascular occlusion (within 12 months prior to the first brolucizumab injection) should be closely monitored, since they are at increased risk of developing retinal vasculitis and/or retinal vascular occlusion.
The interval between two Beovu doses during maintenance treatment should not be less than 8 weeks considering that a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion was reported in patients with nAMD who received Beovu every 4 week maintenance dosing in a clinical study compared to patients who received Beovu every 8 or 12 week maintenance dosing in the pivotal Phase III clinical studies.
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.
6 Bilateral treatment The safety and efficacy of brolucizumab administered in both eyes concurrently have not been studied. 8). 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.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

GBUnited Kingdom· MHRA

EUEuropean Union· EMA

Drugs in the same class

Sources & citations