Eylea 114,3 mg/ml solucion inyectable

Prescribing Information for the Patient

Eylea 114.3 mg/mL Injectable Solution

aflibercept

Read this entire prescribing information carefully before you receive this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this prescribing information. See section 4.

What is Eylea

Eylea contains the active ingredient aflibercept. It belongs to a group of medicines called anti-neovascularization agents.

Your doctor will inject Eylea into your eye to treat certain eye disorders in adult patients known as:

• age-related macular degeneration (AMD exudative)
• vision loss due to diabetic macular edema (DME).

These disorders affect the macula. The macula is the central part of the light-sensitive membrane located at the back of the eye. It is responsible for clear vision.

AMD exudative occurs when abnormal blood vessels form and grow under the macula. Abnormal blood vessels can leak fluid or blood into the eye. Leaking blood vessels that cause macula swelling lead to DME. Both disorders can affect your vision.

How Eylea works

Eylea stops the growth of new abnormal blood vessels in the eye. Eylea may help stabilize and, in many cases, improve vision.

You should not be given Eylea if

• you are allergic to aflibercept or any of the other ingredients in this medicine (listed in section 6)
• you have an infection in your eye or around it
• you have pain or redness in your eye (a severe inflammation of the eye).

Warnings and precautions

Consult your doctorbefore they administerEylea if:

• you have glaucoma, an eye disease caused by high pressure in the eye
• you have a history of flashes of light or dark floating spots and if their size or number increases suddenly
• you have had eye surgery in the last 4 weeks or have a scheduled eye surgery in the next 4 weeks.

Inform your doctorimmediately ifyou experience:

• eye redness
• eye pain
• increased eye discomfort
• blurred or decreased vision
• increased sensitivity to light

These may be symptoms of inflammation or infection and your doctor may interrupt treatment with Eylea.

Also, it is essential that you know:

• The safety and efficacy of Eylea when administered in both eyes at the same time have not been studied and such use may increase the risk of adverse effects.
• Eylea injections may cause an increase in eye pressure in some patients within 60 minutes after the injection. Your doctor will monitor you after each injection.
• Your doctor will check for other risk factors that may increase the likelihood of a tear or detachment of the posterior layers of the eye. In such cases, your doctor will administer Eylea with caution.
• Women of childbearing age should use effective contraceptive methods during treatment and for at least 4 months after the last Eylea injection.

The use of substances similar to those contained in Eylea is potentially related to the risk of blockage of blood vessels by blood clots, which may lead to a heart attack or stroke. Theoretically, this could also occur after an Eylea injection in the eye. If you have had a stroke, a transient ischemic attack, or a heart attack in the last 6 months, your doctor will administer Eylea with caution.

Children and adolescents

Eylea has not been studied in children and adolescents under 18 years of age, as the indicated diseases primarily occur in adults. Therefore, its use is not justified in this age group.

Other medicines and Eylea

Inform your doctor if you are using, have used recently, or may need to use any other medicine.

Pregnancy and breastfeeding

• Women who may become pregnant should use effective contraceptive methods during treatment and for at least 4 months after the last Eylea injection.
• There is limited experience with 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 fetus.
• Small amounts of Eylea may pass into breast milk. The effect on newborns/breastfed infants is unknown. Eylea is not recommended during breastfeeding.

Therefore, if you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

Driving and operating machines

After the Eylea injection, you may experience some temporary vision problems. Do not drive or operate machines while these problems persist.

Eylea contains polysorbate 20

This medicine contains 0.021 mg of polysorbate 20 in each 0.07 ml dose equivalent to 0.3 mg/ml.

Polysorbates can cause allergic reactions. Inform your doctor if you have any known allergies.

The recommended dose is 8 mg of aflibercept per injection.

• You will receive 1 injection every month for the first 3 months.
• After this, you may receive injections every 5 months. Your doctor will decide the frequency based on the condition of your eye.

Administration form

Your doctor will inject Eylea into the interior of your eye (intravitreal injection).

Before the injection, your doctor will use an antiseptic eye wash to carefully clean your eye to prevent an infection. Your doctor will administer an eye drop (local anesthetic) to numb your eye to reduce or prevent pain from the injection.

If you have not received a dose of Eylea

Ask for a new appointment with your doctor as soon as possible.

Before interrupting treatment with Eylea

Speak with your doctor before interrupting treatment. Stopping treatment may increase the risk of vision loss and your vision may worsen.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects of Eylea injection are due to the medicine itself or the injection procedure and mostly affect the eye.

Some side effects can be serious

Immediately contact your doctor if you experience any of the following conditions:

• 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 hemorrhage)
• Increased pressure inside the eye
• Bleeding in the eye (vitreous hemorrhage)
• Uncommon side effect, which may affect up to 1 in 100 people

• Certain forms of lens clouding (subcapsular/nuclear cataract)
• Detachment, tear, or hemorrhage of the light-sensitive layer at the back of the eye, which produces flashes of light with floating spots that sometimes progresses to loss of vision (retinal detachment or tear)

Other possible side effects

Common(may affect up to 1 in 10 people):

• Allergic reactions
• Visual disturbances (floaters in the vitreous humor)
• Detachment of the gel-like substance found inside the eye (vitreous detachment)
• Decreased visual acuity
• Ocular pain
• Bleeding in the eye (conjunctival hemorrhage)
• Damage to the transparent layer of the eyeball in front of the iris (keratitis punctata, corneal abrasion)

Uncommon(may affect up to 1 in 100 people):

• Detachment or tear of one of the layers at the back of the eye that produces flashes of light with floating spots that sometimes progresses to loss of vision (pigment epithelial retinal detachment or tear)
• Inflammation of the iris, other parts of the eye, or the gel-like substance found inside the eye (uveitis, iritis, iridocyclitis, vitritis)
• Certain forms of lens clouding (cortical cataract)
• Damage to the superficial layer of the eyeball (corneal erosion)
• Blurred vision
• Pain at the injection site
• Sensation of having something inside the eye
• Increased tear production
• Bleeding at the injection site
• Eye redness
• Swelling of the eyelid
• Eye redness (ocular hyperemia)
• Irritation at the injection site

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

• Swelling of the superficial layer of the eyeball (corneal edema)
• Lens clouding (lenticular opacity)
• Degeneration of the light-sensitive membrane at the back of the eye (retinal degeneration)
• Irritation of the eyelid

Unknown frequency(cannot be estimated from available data):

• Inflammation of the white part of the eye associated with redness and pain (scleritis)

In addition to those previously mentioned, the following side effects may occur, although they have not been reported in clinical studies:

• Abnormal sensation in the eye
• Damage to the surface of the transparent front part of the eye (corneal epithelial defect)
• Inflammation of other parts of the eye (cells floating in the anterior chamber)
• Severe inflammation or infection inside the eye (endophthalmitis)
• Blindness
• Lens clouding due to injury (traumatic cataract)
• Pus in the eye (hypopyon)
• Severe allergic reactions

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and on the label after “CAD/EXP”. The expiration date is the last day of the month indicated.
• Store in refrigerator (between 2 °C and 8 °C). Do not freeze.
• The unopened vial can be stored outside the refrigerator below 25 °C for a maximum of 24 hours.
• Store the vial in the outer packaging to protect it from light.

Composition of Eylea

• The active ingredient is aflibercept. 1 ml of solution contains 114.3 mg of aflibercept. Each vial contains 0.263 ml. This provides a usable amount to administer a single dose of 0.07 ml containing 8 mg of aflibercept.
• The other components are: sucrose, arginine hydrochloride, histidine hydrochloride monohydrate, histidine, polisorbate 20, water for injection.

See “Eylea contains polisorbate 20” in section 2 for more information.

Appearance of Eylea and contents of the pack

Eylea is an injectable solution. The solution is colourless to pale yellow.

Pack: 1 vial + 1 filter needle.

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen

Germany

Responsible Person

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

For local information, scan here to access the websitehttps://www.pi.bayer.com/eylea3.

A QR code with the link to the leaflet is included.

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This information is intended solely for healthcare professionals:

The vial is for single use in one eye. Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.

Do notuse if the packaging or its components have expired, show damage or have been manipulated. Check the label on the vial to ensure you have the dose of Eylea you intended to use. The 8 mg dose requires the use of the Eylea vial 114.3 mg/ml.

Intravitreal injection should be performed with a 30 G × ½ inch (1.27 cm) injection needle (not included).

Use of a needle of smaller size (larger gauge) than the recommended 30 G × ½ inch (1.27 cm) injection needle may cause an increase in injection force.

Unused medication and all materials that have come into contact with it will be disposed of in accordance with local regulations.