Drugs List

Therapeutic Indications

Uses

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

Administration

For intravitreal use only.

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 disorder
History of myocardial infarction
History of transient ischaemic attack
Pregnancy
Uncontrolled glaucoma

Suspend treatment if planned surgery within next 28 days
Advise patient blurred vision may affect ability to drive/operate machinery
Treatment to be prescribed and administered by a specialist
Contains polysorbate
Discard any unused portion
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Monitor and manage perfusion of optic nerve head
Monitor intra-ocular pressure post injection and manage appropriately
Advise patient to report any symptoms of endophthalmitis immediately
Advise patient to report any unexpected changes in eye symptoms immediately
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 retinal break or tear develops
Female: Contraception required during and for 3 months after treatment

Arterial thromboembolic events (ATE's): Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors, including faricimab, and there is a theoretical risk that these may be related to VEGF inhibition.

There is a potential for immunogenicity with faricimab. Patients should be instructed to inform their physician of any signs or symptoms of intraocular inflammation such as vision loss, eye pain, increased sensitivity to light, floaters or worsening eye redness, which may be a clinical sign attributable to hypersensitivity.

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

Pregnancy and Lactation

Pregnancy

Use faricimab with caution during pregnancy.

The manufacturer advises that as a precautionary measure it is preferable to avoid the use of faricimab during pregnancy unless the potential benefit outweighs the potential risk to the fetus. At the time of writing, there is no or limited amount of data from the use of faricimab in pregnant women. Systemic exposure after ocular administration of faricimab is very low. Animal studies in pregnant cynomolgus monkeys did not indicate direct or indirect harmful effects with respect to reproductive toxicity including embryo-fetal development.

Lactation

Faricimab is contraindicated during breastfeeding.

The manufacturer advises that a decision must be made whether to discontinue breastfeeding or to discontinue faricimab treatment taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women. It is unknown whether faricimab is excreted in human milk. A risk to the breastfed infant/newborn cannot be excluded.

Side Effects

Abnormal vision
Arterial thrombosis
Blurred vision
Cataracts
Conjunctival haemorrhage
Conjunctival hyperaemia
Corneal abrasion
Endophthalmitis
Eye disorder
Eye irritation
Eye pain
Eye pruritus
Haemorrhage
Increased intra-ocular pressure
Increased lacrimation
Iridocyclitis
Iritis
Ocular discomfort
Ocular hyperaemia
Ocular inflammation
Reduced visual acuity
Retinal detachment
Retinal pigment epithelial tear
Retinal tear
Sensation of foreign body in eye
Uveitis
Vitreous floaters
Vitreous haemorrhage
Vitritis

Presentation

Intravitreal injection of faricimab.

These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.

Drugs List

Therapeutic Indications

Uses

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

Dosage

Faricimab is intended for long-term treatment.

Adults

Administration

For intravitreal use only.

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 disorder
History of myocardial infarction
History of transient ischaemic attack
Pregnancy
Uncontrolled glaucoma

Suspend treatment if planned surgery within next 28 days
Advise patient blurred vision may affect ability to drive/operate machinery
Treatment to be prescribed and administered by a specialist
Contains polysorbate
Discard any unused portion
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Monitor and manage perfusion of optic nerve head
Monitor intra-ocular pressure post injection and manage appropriately
Advise patient to report any symptoms of endophthalmitis immediately
Advise patient to report any unexpected changes in eye symptoms immediately
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 retinal break or tear develops
Female: Contraception required during and for 3 months after treatment

Arterial thromboembolic events (ATE's): Systemic adverse events including arterial thromboembolic events have been reported following intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors, including faricimab, and there is a theoretical risk that these may be related to VEGF inhibition.

There is a potential for immunogenicity with faricimab. Patients should be instructed to inform their physician of any signs or symptoms of intraocular inflammation such as vision loss, eye pain, increased sensitivity to light, floaters or worsening eye redness, which may be a clinical sign attributable to hypersensitivity.

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

Pregnancy and Lactation

Pregnancy

Use faricimab with caution during pregnancy.

The manufacturer advises that as a precautionary measure it is preferable to avoid the use of faricimab during pregnancy unless the potential benefit outweighs the potential risk to the fetus. At the time of writing, there is no or limited amount of data from the use of faricimab in pregnant women. Systemic exposure after ocular administration of faricimab is very low. Animal studies in pregnant cynomolgus monkeys did not indicate direct or indirect harmful effects with respect to reproductive toxicity including embryo-fetal development.

Lactation

Faricimab is contraindicated during breastfeeding.

The manufacturer advises that a decision must be made whether to discontinue breastfeeding or to discontinue faricimab treatment taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women. It is unknown whether faricimab is excreted in human milk. A risk to the breastfed infant/newborn cannot be excluded.

Side Effects

Abnormal vision
Arterial thrombosis
Blurred vision
Cataracts
Conjunctival haemorrhage
Conjunctival hyperaemia
Corneal abrasion
Endophthalmitis
Eye disorder
Eye irritation
Eye pain
Eye pruritus
Haemorrhage
Increased intra-ocular pressure
Increased lacrimation
Iridocyclitis
Iritis
Ocular discomfort
Ocular hyperaemia
Ocular inflammation
Reduced visual acuity
Retinal detachment
Retinal pigment epithelial tear
Retinal tear
Sensation of foreign body in eye
Uveitis
Vitreous floaters
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: August 2022

Reference Sources

Summary of Product Characteristics: Vabysmo 120mg/ml solution for injection. Roche Products Limited. Revised May 2022.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2022