Eylea 114.3 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Eylea 114.3 mg/ml solution for injection in a pre-filled syringe

aflibercept

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Eylea is and what it is used for
2. What you need to know before being given Eylea
3. How Eylea will be administered
4. Possible adverse effects
5. How to store Eylea
6. Contents of the pack and other information

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 anti-angiogenesis agents.

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

• wet age-related macular degeneration (wet AMD)
• vision loss due to diabetic macular edema (DME)
• vision loss due to macular edema secondary to retinal vein occlusion (branch, central, and hemi-retinal vein occlusion).

These disorders affect the macula. The macula is the central part of the light-sensitive layer at the back of the eye. It is responsible for sharp, central vision.

Wet AMD occurs when abnormal blood vessels form and grow beneath the macula. These abnormal blood vessels may leak fluid or blood into the eye. Leaking blood vessels that cause swelling of the macula result in DME. In patients with retinal vein occlusion (RVO), one or more blood vessels carrying blood away from the retina are blocked. As a result, levels of VEGF increase, causing fluid to leak into the retina and leading to swelling of the macula (the part of the retina responsible for fine vision). This swelling is called macular edema. When the macula becomes swollen with fluid, central vision becomes blurred.

These conditions can affect your vision.

How Eylea works

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

2. What you need to know before Eylea is administered to you

You must not be given Eylea if

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

Warnings and precautions

Talk to your doctor before you are given Eylea if:

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

Tell your doctor immediately if you experience:

• redness of the eye
• eye pain
• increased eye discomfort
• blurred or reduced vision
• increased sensitivity to light

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

In addition, it is important for you to know that:

• the safety and efficacy of Eylea when administered in both eyes simultaneously 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 assess other risk factors that may increase the likelihood of a tear or detachment of the back layers of the eye. In such cases, your doctor will administer Eylea with caution.
• women of childbearing potential must 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 associated with the risk of blood vessel blockage due to blood clots, which may lead to myocardial infarction or stroke. Theoretically, this could also occur following an eye injection of Eylea. If you have had a stroke, transient ischemic attack, or myocardial infarction within the past 6 months, your doctor will administer Eylea with caution.

Children and adolescents

The use of Eylea has not been studied in children and adolescents under 18 years of age, as the conditions treated occur primarily in adults. Therefore, its use is not recommended in this age group.

Other medicines and Eylea

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

• Women of childbearing potential must use effective methods of contraception during treatment and for at least 4 months after the last Eylea injection.
• Experience with Eylea use in pregnant women is limited. 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/infants fed breast milk is unknown. The use of Eylea during breastfeeding is not recommended.

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

Driving and using machines

After receiving an Eylea injection, you may experience some transient visual disturbances. Do not drive or operate machinery while these disturbances last.

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

3. How Eylea will be administered

The recommended dose is 8 mg of aflibercept per injection.

Exudative AMD and DME

• You will receive 1 injection every month for the first 3 months.
• After this, you may receive injections up to every 6 months. Your doctor will decide the frequency based on the condition of your eye.
• If your doctor switches your treatment to Eylea 114.3 mg/ml, your doctor will determine the frequency after the first injection.

Macular oedema secondary to RVO

• You will receive 1 injection every month for the first 3 months.
• After this, your doctor will decide the frequency based on the condition of your eye.
• If your doctor switches your treatment to Eylea 114.3 mg/ml, your doctor will determine the frequency after the first injection.

Method of administration

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

Before the injection, your doctor will use a disinfectant eye wash to carefully clean your eye to prevent infection. Your doctor will administer eye drops (local anaesthetic) to numb the eye in order to reduce or prevent injection pain.

If a dose of Eylea has not been administered

Make a new appointment with your doctor as soon as possible.

Before stopping Eylea treatment

Talk to your doctor before stopping treatment. Stopping treatment may increase the risk of vision loss and your vision may worsen.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Some side effects may be serious

Contact your doctor immediately if you experience any of the following:

• Common side effect, which may affect up to 1 in 10 people

  • Clouding of the lens (cataract)
  • Increased pressure inside the eye

• Bleeding at the back of the eye (retinal haemorrhage)

• Bleeding inside the eye (vitreous haemorrhage)

• Uncommon side effect, which may affect up to 1 in 100 people

• Certain forms of lens clouding (subcapsular/nuclear cataract)

• Detachment, tear, or bleeding of the light-sensitive layer at the back of the eye, causing flashes of light and floating spots, which sometimes progresses to vision loss (retinal tear or detachment)

Other possible side effects

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

• Allergic reactions
• Spots in vision (floaters in the vitreous humour)
• Detachment of the gel-like substance inside the eye (vitreous detachment)
• Decreased visual acuity
• Eye pain
• Bleeding inside the eye (conjunctival haemorrhage)
• Damage to the transparent layer at the front 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 at the back of the eye, causing flashes of light and floating spots, which sometimes progresses to vision loss (retinal pigment epithelial tear/detachment)
• Inflammation of the iris, other parts of the eye, or the gel-like substance inside the eye (uveitis, iritis, iridocyclitis, vitritis)
• Certain forms of lens clouding (cortical cataract)
• Damage to the surface of the eyeball (corneal erosion)
• Blurred vision
• Pain at injection site
• Sensation of having something in the eye
• Increased tear production
• Bleeding at injection site
• Redness of the eye
• Clouding of the lens (lenticular opacity)
• Swelling of the eyelid
• Redness of the eye (ocular hyperaemia)
• Irritation at injection site
• Degeneration of the light-sensitive membrane at the back of the eye (retinal degeneration)
• Swelling of the surface layer of the eyeball (corneal oedema)

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

• Blindness
• Severe inflammation and infection inside the eye (endophthalmitis)
• Eyelid irritation

Frequency not known (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:

• 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)
• Clouding of the lens 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, talk to your doctor, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eylea

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label after “CAD/EXP”. The expiry date refers to the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Keep the pre-filled syringe in its blister and in the outer packaging to protect it from light.
• Before use, the unopened Eylea blister can be stored outside the refrigerator at temperatures below 25 °C for up to 24 hours.

6. Contents of the pack and other information

Composition of Eylea

• The active substance is aflibercept. 1 ml of solution contains 114.3 mg of aflibercept. Each pre-filled syringe contains 0.184 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, monohydrate histidine hydrochloride, histidine, polysorbate 20, water for injections.

See "Eylea contains polysorbate 20" in section 2 for more information.

Appearance of Eylea and contents of the pack

Eylea 114.3 mg/ml solution for injection in pre-filled syringe is an injectable solution (injectable). The solution is colourless to pale yellow.

Pack: 1 pre-filled syringe.

Marketing Authorization Holder

Bayer AG
51368 Leverkusen
Germany

Manufacturer

Bayer AG
Müllerstraße 178
13353 Berlin
Germany

More information about this medicine is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of last review of this leaflet:

Other sources of information

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

For local information, scan here to access the website https://www.pi.bayer.com/eylea4.

A QR code linking to the package leaflet is included.

This information is intended for healthcare professionals only:

The pre-filled syringe with OcuClick delivery system is for single use in one eye only. Withdrawing multiple doses from a single pre-filled syringe with OcuClick delivery system may increase the risk of contamination and subsequent infection.

Do not use if the packaging or its components are expired, damaged, or have been tampered with.

Check the label on the pre-filled syringe with OcuClick delivery system to ensure that you have the Eylea dose intended for use. The 8 mg dose requires the use of the Eylea pre-filled syringe at a concentration of 114.3 mg/ml.

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

Using a smaller needle (higher gauge) than the recommended 30 G × ½ inch (1.27 cm) injection needle may result in increased injection force.

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.