Aflibercept ocular
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection solution containing aflibercept.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) K1 cell lines.
Drugs List
Therapeutic Indications
Uses
Macular oedema following branch or central retinal vein occlusion
Treatment of neovascular age-related macular degeneration
Treatment of visual impairment due to diabetic macular oedema
Treatment of visual impairment due to myopic choroidal neovascularisation
Dosage
The dose should be withheld within the previous or next 28 days in the event of a performed or planned intraocular surgery.
Adults
wet AMD
Recommended dose: 2mg (50microlitres). Initiate with 1 injection per month for 3 consecutive doses, followed by 1 injection every 2 months. There is no requirement for monitoring between injections.
After the first 12 months of treatment, and based on visual and/or anatomic outcomes, the treatment interval may be extended such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased in 2 or 4 weekly increments to maintain stable visual and/or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly. The schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections.
Macular Oedema secondary to RVO (branch RVO or central RVO)
Recommended dose: 2mg (50microlitres). Monthly treatment continues until maximum visual acuity is achieved and/or there are no signs of disease activity. The interval between two doses should not be shorter than one month. 3 or more consecutive monthly injections may be needed.
Treatment may then be continued with a treat and extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly.
If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, this medication should be discontinued.
The monitoring and treatment schedule should be determined by the treating physician, based on the individual patient's response.
Diabetic Macular Oedema
Recommended dose: 2mg (50microlitres). Initiate with 1 injection per month for 5 consecutive doses, followed by 1 injection every 2 months. There is no requirement for monitoring between injections.
After the first 12 months of treatment, and based on visual and/or anatomic outcomes, the treatment interval may be extended such as with a treat-and-extend dosing regimen, where the treatment intervals are gradually increased to maintain stable visual and/or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly. The schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections.
If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, this medication should be discontinued.
Myopic Choroidal Neovascularisation
Recommended dose: 2mg (50microlitres). Additional doses may be administered if visual and/or anatomic outcomes indicate that the disease persists. Recurrences should be treated as a new manifestation of the disease. The schedule for monitoring should be determined by the treating physician. The interval between 2 doses should not be shorter than 1 month.
Administration
For intravitreal administration.
Each vial or pre-filled syringe should only be used for the treatment of a single eye.
Contraindications
Children under 18 years
Breastfeeding
Irreversible ischaemic loss of vision
Ocular infection
Periocular infection
Pregnancy
Recent ocular surgery
Severe intra-ocular inflammation
Precautions and Warnings
Females of childbearing potential
Predisposition to retinal detachment
Risk factors for retinal pigment epithelial tears
Systemic infection
Diabetes mellitus
Diabetic retinopathy
Glaucoma
Thromboembolic disorder
Uncontrolled hypertension
Within 6 month of cerebrovascular accident
Within 6 months of a myocardial infarction
Within 6 months of a transient ischaemic attack
Advise patient blurred vision may affect ability to drive/operate machinery
Contains polysorbate
Discard any unused portion
For single use only
Record name and batch number of administered product
Treatment to be administered by or under supervision of specialist
Monitor and manage perfusion of optic nerve head
Monitor during the week following injection for signs of infection
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 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 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: Contraception required during and for 3 months after treatment
Pregnancy and Lactation
Pregnancy
Aflibercept is contraindicated during pregnancy.
The manufacturer notes that although the systemic exposure after ocular administration is very low, this medication is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
There is no data on the use of aflibercept in pregnant women. Studies in animals have shown embryo-foetal toxicity after high systemic exposure.
Lactation
Aflibercept is contraindicated during breastfeeding.
The manufacturer notes that a decision must be made whether to discontinue breastfeeding or to abstain from this therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Is it unknown whether aflibercept is excreted in human milk. A risk to the breastfed child cannot be excluded.
Side Effects
Abnormal sensation in eye
Anaphylactic reaction
Anaphylactoid reaction
Anterior chamber inflammation
Blindness
Blurred vision
Cataracts
Conjunctival haemorrhage
Conjunctival hyperaemia
Corneal abrasion
Corneal epithelium defect
Corneal erosion
Corneal oedema
Cortical cataract
Detachment of the retinal pigment epithelium
Endophthalmitis
Eye pain
Eyelid oedema
Eyelid reaction
Floaters
Haemorrhage (injection site)
Hypersensitivity reactions
Hypopyon
Increased intra-ocular pressure
Increased lacrimation
Iridocyclitis
Iritis
Irritation (injection site)
Lens opacities
Local pain (injection site)
Nuclear cataract
Ocular hyperaemia
Pruritus
Punctate keratitis
Rash
Reduced visual acuity
Retinal degeneration
Retinal detachment
Retinal haemorrhage
Retinal pigment epithelial tear
Retinal tear
Sensation of foreign body in eye
Subcapsular cataract
Traumatic cataract
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: June 2020
Reference Sources
Summary of Product Characteristics: Eylea 40mg/ml solution for injection in a vial. Bayer PLC. Revised January 2021.
Summary of Product Characteristics: Eylea 40mg/ml solution for injection in pre-filled syringe. Bayer PLC. Revised April 2020.
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