Faricimab intravitreal injection
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Intravitreal injection of faricimab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Treatment of neovascular age-related macular degeneration
Treatment of visual impairment due to diabetic macular oedema
Faricimab is intended for long-term treatment.
6mg (0.05ml solution) every 4 weeks for the first 4 doses.
Neovascular age-related macular degeneration (nAMD).
An assessment of disease activity based on anatomic and/or visual outcomes is recommended 20 and/or 24 weeks after treatment initiation so treatment can be individualised. In patients without disease activity, administration of faricimab every 16 weeks should be considered. In patients with disease activity, treatment every 8 weeks or 12 weeks should be considered.
Visual impairment due to diabetic macular oedema (DMO).
Treatment may be individualised using a treat-and-extend approach following an assessment of the individual patient's anatomic and visual outcomes. The dosing interval may be extended from every 4 to every 16 weeks, with extensions in increments of up to 4 weeks, based on the physician's judgement of the individual patient's anatomic and/or visual outcomes. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reductions of up to 8 weeks may be implemented if deemed necessary.
For intravitreal use only.
Children under 18 years
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
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
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
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.
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.
Increased intra-ocular pressure
Reduced visual acuity
Retinal pigment epithelial tear
Sensation of foreign body in eye
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 ).
Last Full Review Date: August 2022
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
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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