Patient leaflet - Eylea 114.3 mg/ml solution for injection in Pre-filled syringe
1. What Eylea is and what it is used for What Eylea is
Eylea contains the active substance aflibercept. It belongs to a group of medicines called antineovascularistion agents.
Your doctor will inject Eylea into your eye to treat eye disorders in adults called:
RR wet age-related macular degeneration (wet AMD) RR visual impairment due to diabetic macular oedema (DMO). RR visual impairment due to macular oedema secondary to retinal
vein occlusion (branch, central and hemiretinal RVO).
These disorders affect the macula. The macula is the central part of the light sensitive membrane at the back of the eye. It is responsible for clear vision.
Wet AMD is caused when abnormal blood vessels form and grow below the macula. The abnormal blood vessels may leak fluid or blood into the eye. Leaky blood vessels that cause swelling of the macula cause DMO. In patients with RVO, one or more blood vessels that transports blood away from the retina are blocked. VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular oedema. When the macula swells with fluid, central vision becomes blurry. These disorders may impact your vision.
How Eylea works
Eylea stops growth of new abnormal blood vessels in the eye. Eylea can help to stabilise and often improve vision.
2. What you need to know before you receive Eylea You will not receive Eylea if you
RR are allergic to aflibercept or any of the other ingredients of this
medicine (listed in section 6)
RR have an infection in or around the eye
RR have pain or redness in your eye (severe eye inflammation).
Warnings and precautions
Talk to your doctor before receiving Eylea if you:
RR have glaucoma – an eye condition caused by high pressure in
the eye
RR have a history of seeing flashes of light or dark floating spots
and if their size or number suddenly increases
RR had eye surgery in the last 4 weeks or eye surgery is planned in
the next 4 weeks.
Tell your doctor immediately if you develop:
RR redness of the eye
RR eye pain
RR increased discomfort
RR blurred or decreased vision
RR increased sensitivity to light
These may be symptoms of an inflammation or infection and your doctor may stop giving you Eylea.
Furthermore, it is important for you to know that:
RR the safety and efficacy of Eylea when administered to both eyes
at the same time have not been studied and such use may increase risk of experiencing side effects.
RR injections with Eylea may cause an increase in eye pressure in
some patients within 60 minutes of the injection. Your doctor will monitor this after each injection.
RR your doctor will check for other risk factors that may increase
the chance of a tear or detachment of one of the layers at the back of the eye. In such cases your doctor will give you Eylea with caution.
RR women who could become pregnant must use effective birth
control during treatment and for at least 4 months after the last injection of Eylea.
The use of substances similar to those contained in Eylea is potentially related to the risk of blood clots blocking blood vessels, which may lead to heart attack or stroke. Theoretically, this could also happen after an injection of Eylea into the eye. If you had a stroke, a mini-stroke or a heart attack within the last 6 months, your doctor will give you Eylea with caution.
Children and adolescents
The use of Eylea in children or adolescents under 18 has not been studied because the diseases indicated occur mainly in adults. Therefore, its use in this age group is not relevant.
Other medicines and Eylea
Tell your doctor if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
RR Women who could become pregnant must use effective birth
control during treatment and for at least 4 months after the last injection of Eylea.
RR There is limited experience on the use of Eylea in pregnant
women. Women should not receive Eylea during pregnancy unless the potential benefit to the woman outweighs the potential risk to the unborn child.
RR Small amounts of Eylea may pass into human milk. The effect
on breast-fed newborns/infants are unknown. Eylea is not recommended during breast-feeding.
Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine.
Driving and using machines
After receiving Eylea, you may experience some temporary vision problems. Do not drive or use machines as long as these last.
Eylea contains polysorbate 20
This medicine contains 0.021 mg of polysorbate 20 in each 0.07 ml dose which is equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How Eylea will be given
The recommended dose is 8 mg aflibercept per injection.
wet AMD and DMO
RR You will receive 1 injection every month for the first 3 months. RR After that, you may receive injections up to every 6 months. Your
doctor will decide on the frequency based on the condition of your eye.
RR If your doctor changes your treatment to Eylea 114.3 mg/ml,
your doctor will decide on the frequency after the first injection.
macular oedema secondary to RVO
RR You will receive 1 injection every month for the first 3 months. RR After that, your doctor will decide on the frequency based on the
condition of your eye.
RR If your doctor changes your treatment to Eylea 114.3 mg/ml,
your doctor will decide on the frequency after the first injection.
Method of administration
Your healthcare professional will inject Eylea into your eye (intravitreal injection).
Before the injection, your healthcare professional will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your healthcare professional will give you an eye drop (local anaesthetic) to numb the eye to reduce or prevent pain from the injection.
If you missed a dose of Eylea
Make a new appointment with your doctor as soon as possible.
Before stopping Eylea treatment
Speak with your doctor before stopping treatment. Stopping treatment may increase your risk of vision loss and your vision may worsen.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of Eylea injection are either from the medicine itself or from the injection procedure and mostly affect the eye.
Some side effects could be serious
Contact your doctor immediately if you have any of the following: RR common side effect, which may affect up to 1 in 10 people
PP clouding of the lens (cataract)
PP increase of pressure inside the eye
PP bleeding in the back of the eye (retinal haemorrhage) PP bleeding inside the eye (vitreous haemorrhage) RR uncommon side effect, which may affect up to 1 in 100 people
PP certain forms of clouding of the lens (cataract subcapsular/ nuclear)
PP detachment, tear or bleeding of the light-sensitive layer at the back of the eye, resulting in flashes of light with floaters, sometimes progressing to a loss of vision (retinal detachment or tear)
Other possible side effects
Common (may affect up to 1 in 10 people):
RR allergic reactions
RR moving spot in your vision (vitreous floaters)
RR detachment of the gel-like substance inside the eye (vitreous detachment)
RR reduced sharpness of vision
RR eye pain
RR bleeding inside the eye (conjunctival haemorrhage) RR damage to the clear layer of the eyeball in front of the iris
(punctate keratitis, corneal abrasion)
Uncommon (may affect up to 1 in 100 people):
RR detachment or tear of one of the layers in the back of the eye, resulting in flashes of light with floaters, sometimes progressing to a loss of vision (retinal pigment epithelial tear/detachment) RR inflammation in the iris, of other parts of the eye, or the gel-like substance inside the eye (uveitis, iritis, iridocyclitis, vitritis) RR certain forms of clouding of the lens (cataract cortical) RR damage to the front layer of the eyeball (corneal erosion) RR blurred vision
RR eye pain at injection site
RR a feeling of having something in the eye
RR increased tear production
RR bleeding at the injection site
RR redness of the eye
RR clouding of the lens (lenticular opacities)
RR swelling of the eyelid
RR redness of the eye (ocular hyperaemia)
RR irritation at injection site
RR degeneration of the light sensitive membrane at the back of the eye (retinal degeneration)
RR swelling of the front layer of the eyeball (corneal oedema)
Rare (may affect up to 1 in 1 000 people):
RR blindness
RR serious inflammation or infection inside the eye
(endophthalmitis)
RR eyelid irritation
RR inflammation of blood vessels in the back of the eye (retinal vasculitis)
Not known (frequency cannot be estimated from the available data):
RR inflammation of the white part of the eye associated with redness and pain (scleritis)
RR blockage of blood vessels in the back of the eye, typically in presence of inflammation (retinal occlusive vasculitis)
Besides the above the following side effects may occur: RR abnormal sensation in eye
RR damage to the surface of the clear front layer of the eye (corneal epithelium defect)
RR inflammation of other parts of the eye (anterior chamber flare) RR clouding of the lens due to injury (traumatic cataract) RR pus in the eye (hypopyon)
RR severe allergic reactions
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Eylea
RR Keep this medicine out of the sight and reach of children. RR Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
RR Store in a refrigerator (2 °C – 8 °C). Do not freeze. RR Keep the pre-filled syringe in its blister and in the outer carton in order to protect from light.
RR Prior to usage, the unopened blister may be stored outside the refrigerator below 25 °C for up to 24 hours.
6. Contents of the pack and other information
What Eylea contains
RR The active substance is aflibercept. 1 ml solution contains
114.3 mg aflibercept. Each pre-filled syringe contains 0.184 ml. This provides a usable amount to deliver a single dose of 0.07 ml containing 8 mg aflibercept.
RR The other ingredients are: sucrose, arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polysorbate 20, water for injections.
See ‘Eylea contains polysorbate 20’ in section 2 for more information.
What Eylea looks like and contents of the pack
Eylea 114.3 mg/ml solution for injection in pre-filled syringe is a solution for injection (injection). The solution is colourless to pale yellow.
Pack size: 1 pre-filled syringe.
Marketing Authorisation Holder
Bayer plc
400 South Oak Way
Reading
RG2 6AD
Manufacturer
Bayer AG
Müllerstraße 178
13353 Berlin
Germany
For any information about this medicine, please contact Bayer plc, Tel: 0118 206 3000
This leaflet was last revised in July 2026
Package leaflet: Information for the patient
114.3 mg/ml solution for injection in pre-filled syringe
aflibercept
93007772
The following information is intended for healthcare professionals only:
The pre-filled syringe with OcuClick dosing system is for single use in one eye only. Extraction of multiple doses from a single pre-filled syringe with OcuClick dosing system may increase the risk of contamination and subsequent infection.
Do not use if the package or its components are expired, damaged, or have been tampered with.
Check the label on the pre-filled syringe with OcuClick dosing system to make sure you have the strength of Eylea that you intended to use. The 8 mg dose requires use of the Eylea 114.3 mg/ml pre-filled syringe.
The intravitreal injection should be performed with a 30 G × ½ inch injection needle (not included).
Use of a smaller size needle (higher gauge) than the recommended 30 G × ½ inch injection needle may result in increased injection forces.
Pre-filled syringe with integrated OcuClick dosing system description
syringe cap
Luer-lock
plunger stopper
finger grip plunger rod guide | ||
slot 90° view
OcuClick
dosing
system
- 1.
Prepare
When ready to administer Eylea 114.3mg/ml, open the carton and remove the sterile blister. Carefully peel open the blister ensuring the sterility of its contents.
Keep the syringe in the sterile tray until you are ready to attach the injection needle.
Use aseptic technique to carry out steps 2-9.
- 2.
Remove syringe
Remove the syringe from the sterilised blister.
- 3.
Inspect syringe and solution for injection
Do not use the pre-filled syringe if
RR particulates, cloudiness, or discolouration are visible RR any part of the pre-filled syringe with OcuClick dosing system is damaged or loose
RR the syringe cap is detached from the Luer-lock.
- 4.
Snap off syringe cap
To snap off (do not twist off)
the syringe cap, hold the
syringe in one hand and the
syringe cap with the thumb
and forefinger of the other
hand.
Note: Do not pull back on the
plunger rod.
SNAP!
- 5.
Attach needle
Firmly twist the
30 G x ½ inch injection
needle onto the Luer-lock
syringe tip. Luer-lock
- 6.
Dislodge air bubbles
Holding the syringe with the
needle pointing up, check the
syringe for bubbles. If there
are bubbles, gently tap the
syringe with your finger until
the bubbles rise to the top.
TAP!
- 7.
Expel air and excess volume to prime
The syringe does not have a dose line because it is designed to set the dose mechanically as explained in the steps below.
Priming and setting the dose must be done using the following steps.
To eliminate all bubbles and to expel excess medicinal product, slowly depress the plunger rod (left picture below) until it stops, i.e. when the guide on the plunger rod reaches the finger grip (right picture below).
Ensure bubbles are at the top so
they can be expelled.
air
bubble
solution
finger grip
plunger rod
guide
plunger rod
finger grip fully depressed plunger guide
- 8.
Set the dose
Turn the end of the plunger
rod 90 degrees clockwise or
counter clockwise until the
guide of the plunger rod
aligns with the slot. You may
hear a ‘click’.
Note: Now the device is ready
to dose. Do not push the
plunger rod before insertion
into the eye.
CLICK!
slot
guide plunger rod
- 9.
Administer the injection
Insert the needle into the
ocular injection site. Inject
the solution by pushing in
the plunger rod until it stops,
i.e. until the guide is
completely within the slot.
Do not apply additional
pressure once the guide is
within the slot. It is normal to
see a small amount of
residual solution left in the
syringe.
plunger
rod
guide slot
- 10.
The pre-filled syringe is for single dose administration and single use only.
After injection discard the used syringe into a sharps container.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.