Drugs List

Therapeutic Indications

Uses

Treatment of neovascular age-related macular degeneration
Treatment of visual impairment due to diabetic macular oedema

Administration

For intravitreal injection only.

The intravitreal injection should be carried out under aseptic conditions.

The interval between doses during maintenance treatment should not be less than 8 weeks to reduce the risk of intraocular inflammation including retinal vasculitis and retinal vascular occlusion, which has a higher incidence with shorter dosing intervals.

Contraindications

Children under 18 years
Breastfeeding
Ocular infection
Ocular inflammation
Periocular infection
Recent ocular surgery

Precautions and Warnings

Females of childbearing potential
Risk factors for retinal pigment epithelial tears
History of cerebrovascular accident
History of transient ischaemic attack
Pregnancy
Uncontrolled glaucoma
Within 3 months of a myocardial infarction

Suspend treatment if planned surgery within next 28 days
Advise visual disturbances may affect ability to drive or operate machinery
Aseptic technique should be used throughout
Do not start therapy for 28 days post surgery, or until wound has healed
Protect anaesthetised eye from dust and bacterial contamination
Record name and batch number of administered product
Treatment to be administered by or under supervision of specialist
Vary injection site during prolonged therapy
Monitor intra-ocular pressure post injection and manage appropriately
Monitor visual acuity during and after treatment
Advise patient to report any symptoms of endophthalmitis immediately
Advise patient to report any symptoms of retinal detachment immediately
Advise patient to report any unexpected changes in eye symptoms immediately
Discontinue if intraocular inflammation or retinal vascular occlusion occur
Discontinue if rhegmatogenous retinal detachment or stage 3/4 macular holes
Suspend if best-corrected visual activity declines by 30 letters or more
Suspend treatment if central foveal haemorrhage
Suspend treatment if foveal haemorrhage >50% of the total lesion area
Suspend treatment if intraocular pressure of >29 mmHg
Suspend treatment if retinal break or tear develops
Female: May cause infertility
Female: Contraception required during and for 1 month after treatment
Breastfeeding: Do not breastfeed during & for 1 month after treatment

Brolucizumab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).

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 treatment.

Pregnancy and Lactation

Pregnancy

Use brolucizumab with caution during pregnancy.

The manufacturer recommends brolucizumab is not used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. There are no or limited amount of data from the use of brolucizumab in pregnant women. Animal studies are insufficient to determine reproductive toxicity. After ocular use, systemic exposure to brolucizumab is low, but there is a potential risk to embryofoetal development. Brolucizumab should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

Lactation

Brolucizumab is contraindicated during breastfeeding.

The manufacturer advises that brolucizumab is not recommended when breastfeeding and for at least 1 month after the final dose. It is not known whether brolucizumab is excreted in human milk, therefore a risk to the infant cannot be excluded.

Side Effects

Abnormal sensation in eye
Anterior chamber flare
Anterior chamber inflammation
Blindness
Blurred vision
Cataracts
Conjunctival haemorrhage
Conjunctival hyperaemia
Conjunctivitis
Corneal abrasion
Corneal oedema
Detachment of the retinal pigment epithelium
Endophthalmitis
Erythema
Eye pain
Floaters
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Iridocyclitis
Iritis
Ocular inflammation
Pruritus
Punctate keratitis
Rash
Reduced visual acuity
Retinal artery occlusion
Retinal detachment
Retinal haemorrhage
Retinal pigment epithelial tear
Retinal tear
Retinal vascular occlusion
Retinal vasculitis
Urticaria
Uveitis
Vitreous detachment
Vitreous haemorrhage
Vitritis

Presentation

Single use pre-filled syringe containing brolucizumab.

Drugs List

Therapeutic Indications

Uses

Treatment of neovascular age-related macular degeneration
Treatment of visual impairment due to diabetic macular oedema

Dosage

Adults

Administration

For intravitreal injection only.

The intravitreal injection should be carried out under aseptic conditions.

The interval between doses during maintenance treatment should not be less than 8 weeks to reduce the risk of intraocular inflammation including retinal vasculitis and retinal vascular occlusion, which has a higher incidence with shorter dosing intervals.

Contraindications

Children under 18 years
Breastfeeding
Ocular infection
Ocular inflammation
Periocular infection
Recent ocular surgery

Precautions and Warnings

Females of childbearing potential
Risk factors for retinal pigment epithelial tears
History of cerebrovascular accident
History of transient ischaemic attack
Pregnancy
Uncontrolled glaucoma
Within 3 months of a myocardial infarction

Suspend treatment if planned surgery within next 28 days
Advise visual disturbances may affect ability to drive or operate machinery
Aseptic technique should be used throughout
Do not start therapy for 28 days post surgery, or until wound has healed
Protect anaesthetised eye from dust and bacterial contamination
Record name and batch number of administered product
Treatment to be administered by or under supervision of specialist
Vary injection site during prolonged therapy
Monitor intra-ocular pressure post injection and manage appropriately
Monitor visual acuity during and after treatment
Advise patient to report any symptoms of endophthalmitis immediately
Advise patient to report any symptoms of retinal detachment immediately
Advise patient to report any unexpected changes in eye symptoms immediately
Discontinue if intraocular inflammation or retinal vascular occlusion occur
Discontinue if rhegmatogenous retinal detachment or stage 3/4 macular holes
Suspend if best-corrected visual activity declines by 30 letters or more
Suspend treatment if central foveal haemorrhage
Suspend treatment if foveal haemorrhage >50% of the total lesion area
Suspend treatment if intraocular pressure of >29 mmHg
Suspend treatment if retinal break or tear develops
Female: May cause infertility
Female: Contraception required during and for 1 month after treatment
Breastfeeding: Do not breastfeed during & for 1 month after treatment

Brolucizumab should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).

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 treatment.

Pregnancy and Lactation

Pregnancy

Use brolucizumab with caution during pregnancy.

The manufacturer recommends brolucizumab is not used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. There are no or limited amount of data from the use of brolucizumab in pregnant women. Animal studies are insufficient to determine reproductive toxicity. After ocular use, systemic exposure to brolucizumab is low, but there is a potential risk to embryofoetal development. Brolucizumab should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.

Lactation

Brolucizumab is contraindicated during breastfeeding.

The manufacturer advises that brolucizumab is not recommended when breastfeeding and for at least 1 month after the final dose. It is not known whether brolucizumab is excreted in human milk, therefore a risk to the infant cannot be excluded.

Side Effects

Abnormal sensation in eye
Anterior chamber flare
Anterior chamber inflammation
Blindness
Blurred vision
Cataracts
Conjunctival haemorrhage
Conjunctival hyperaemia
Conjunctivitis
Corneal abrasion
Corneal oedema
Detachment of the retinal pigment epithelium
Endophthalmitis
Erythema
Eye pain
Floaters
Hypersensitivity reactions
Increased intra-ocular pressure
Increased lacrimation
Iridocyclitis
Iritis
Ocular inflammation
Pruritus
Punctate keratitis
Rash
Reduced visual acuity
Retinal artery occlusion
Retinal detachment
Retinal haemorrhage
Retinal pigment epithelial tear
Retinal tear
Retinal vascular occlusion
Retinal vasculitis
Urticaria
Uveitis
Vitreous detachment
Vitreous haemorrhage
Vitritis

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2021

Reference Sources

Summary of Product Characteristics: Beovu 120 mg/ml solution for injection in pre-filled syringe. Novartis Pharmaceuticals UK Ltd. Revised April 2022.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 December 2022