Eylea® 114.3 mg/ml – patient leaflet, side effects, dosage

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:

► wet age-related macular degeneration (wet AMD)

► visual impairment due to diabetic macular oedema (DMO).

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. Both 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

► are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6) ► have an infection in or around the eye

► have pain or redness in your eye (severe eye inflammation).

Warnings and precautions

Talk to your doctor before receiving Eylea if you:

► have glaucoma – an eye condition caused by high pressure in the eye

► have a history of seeing flashes of light or dark floating spots and if their size or number suddenly increases ► 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:

► redness of the eye

► eye pain

► increased discomfort

► blurred or decreased vision

► 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:

► 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.

► 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.

► 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. ► 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

► Women who could become pregnant must use effective birth control during treatment and for at least

4 months after the last injection of Eylea.

► 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. ► 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.

► You will receive 1 injection every month for the first 3 months.

► 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.

► 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:

► common side effect, which may affect up to 1 in 10 people

• clouding of the lens (cataract)
• bleeding in the back of the eye (retinal haemorrhage)
• increase of pressure inside the eye
• bleeding inside the eye (vitreous haemorrhage)

► uncommon side effect, which may affect up to 1 in 100 people

• certain forms of clouding of the lens (cataract subcapsular/nuclear)
• 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):

► allergic reactions

► moving spot in your vision (vitreous floaters)

► detachment of the gel-like substance inside the eye (vitreous detachment)

► reduced sharpness of vision

► eye pain

► bleeding inside the eye (conjunctival haemorrhage)

► 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):

► 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) ► inflammation in the iris, of other parts of the eye, or the gel-like substance inside the eye

(uveitis, iritis, iridocyclitis, vitritis)

► certain forms of clouding of the lens (cataract cortical)

► damage to the front layer of the eyeball (corneal erosion)

► blurred vision

► eye pain at injection site

► a feeling of having something in the eye

► increased tear production

► bleeding at the injection site

► redness of the eye

► swelling of the eyelid

► redness of the eye (ocular hyperaemia)

► irritation at injection site

Rare (may affect up to 1 in 1 000 people):

► swelling of the front layer of the eyeball (corneal oedema)

► clouding of the lens (lenticular opacities)

► degeneration of the light sensitive membrane at the back of the eye (retinal degeneration) ► eyelid irritation

Not known (frequency cannot be estimated from the available data):

► inflammation of the white part of the eye associated with redness and pain (scleritis)

Besides the above the following side effects may occur:

► abnormal sensation in eye

► damage to the surface of the clear front layer of the eye (corneal epithelium defect) ► inflammation of other parts of the eye (anterior chamber flare)

► serious inflammation or infection inside the eye (endophthalmitis)

► blindness

► clouding of the lens due to injury (traumatic cataract)

► pus in the eye (hypopyon)

► 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

► Keep this medicine out of the sight and reach of children.

► 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.

► Store in a refrigerator (2 °C – 8 °C). Do not freeze.

► The unopened vial may be stored outside the refrigerator below 25 °C for up to 24 hours. ► Keep the vial in the outer carton in order to protect from light.

If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. Contents of the pack and other information

What Eylea contains

► The active substance is aflibercept. 1 ml solution contains 114.3 mg aflibercept. Each vial contains

0.263 ml. This provides a usable amount to deliver a single dose of 0.07 ml containing 8 mg aflibercept. ► 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 is a solution for injection (injection). The solution is colourless to pale yellow. Pack size: 1 vial + 1 filter needle.

Manufacturer

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

Procured from within the EU and repackaged for the PL Holder: Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom

PL 45763/1008

POM

Eylea^® is a registered trademark of Bayer Aktiengesellschaft

For any information about this medicine, please contact the local representative of the Product Licence Holder: Abacus Medicine Ltd.

tel: +44(0)2036301244,

email: MedInfo@abacusmedicine.co.uk or

drugsafetyuk@abacusmedicine.co.uk

This leaflet was last revised on 18.07.2025

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The following information is intended for healthcare professionals only:

The vial is for single use in one eye only. Extraction of multiple doses from a single vial 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 vial 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 vial.

The intravitreal injection should be performed with a 30 G x 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.

1. 1. Prior to administration visually inspect the solution for injection. Do not use the vial if particulates, cloudiness, or discolouration are visible.
2. 2.

   Remove the plastic cap and disinfect the outer part of the rubber

   stopper of the vial.

3. 3.

   Use aseptic technique to carry out steps 3-10. Attach the filter needle

   supplied in the carton to a 1-ml sterile, Luer-lock syringe.

4. 4. Push the filter needle into the centre of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.
5. 5. Withdraw all of the Eylea vial content into the syringe, keeping the vial in an upright position, slightly

inclined to ease complete withdrawal. To deter the introduction of air, ensure the bevel of the filter needle is submerged into the liquid. Continue to tilt the vial during withdrawal keeping the bevel of the filter needle submerged in the liquid.

solution

needle bevel

pointing down

1. 6. Ensure that the plunger rod is drawn sufficiently back when emptying the vial to completely empty the filter needle. After injection any unused product must be discarded.
2. 7.

   Remove the filter needle and properly dispose of it.

   Note: The filter needle is not to be used for the intravitreal injection.

3. 8.

   Firmly twist the 30 G x ½ inch injection needle onto the

   Luer-lock syringe tip.

4. 9.

   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.

5. 10. To eliminate all bubbles and to expel excess medicinal product, slowly depress the plunger so that the flat

plunger edge aligns with the line that marks 0.07 ml on the syringe.

dose line for 0.07 ml

flat

plunger edge

solution after expelling air bubbles and excess medicinal product

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.