Eylea 40 mg/ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the adult patient

Eylea 40 mg/ml solution for injection in pre-filled syringe

aflibercept

ADULTS

If you require information for caregivers of premature babies, please refer to the end of section 6."

Read all of this leaflet carefully before this medicine is administered to you, because it contains important information for you.

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

Contents of this leaflet

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

1. What Eylea is and what it is used for

Eylea is a solution injected into the eye to treat certain eye diseases in adult patients, namely:

• neovascular (exudative) age-related macular degeneration, commonly known as exudative AMD
• vision impairment due to macular edema caused by retinal vein occlusion (central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO))
• vision impairment due to diabetic macular edema (DME)
• vision impairment due to myopic choroidal neovascularization (myopic CNV).

Aflibercept, the active substance in Eylea, blocks the activity of a group of factors known as vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF).

In patients with exudative AMD and myopic CNV, excessive levels of these factors contribute to the abnormal formation of new blood vessels in the eye. These new blood vessels may leak components of the blood into the eye, causing damage to the ocular tissues responsible for vision.

In patients with CRVO, a blockage occurs in the main vein that carries blood away from the retina. As a result, VEGF levels increase, causing fluid leakage into the retina and thus swelling of the macula (the part of the retina responsible for sharp vision), a condition known as macular edema.

When the macula fills with fluid, central vision becomes blurred.

In patients with BRVO, a blockage occurs in one or more branches of the main vein that carries blood away from the retina. This also leads to increased VEGF levels, causing fluid leakage into the retina and subsequent macular swelling.

Diabetic macular edema is a swelling of the retina that occurs in patients with diabetes due to leakage of fluid from blood vessels in the macula. The macula is the part of the retina responsible for sharp vision. When the macula swells with fluid, central vision becomes blurred.

Eylea has been shown to halt the growth of abnormal new blood vessels in the eye, which often bleed or leak fluid. Eylea can help stabilize, and in many cases improve, vision loss caused by exudative AMD, CRVO, BRVO, DME, and myopic CNV.

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

Do not use Eylea

• if you are allergic to aflibercept or to any of the other components of this medicine (listed in section 6)
• if you have an active infection or suspect you may have an infection in or around your eye (ocular or periocular infection)
• if you have severe inflammation of the eye (indicated by pain or redness).

Warnings and precautions

Talk to your doctor before you are given Eylea:

• If you have glaucoma.
• If you have a history of seeing flashes of light or floaters, or if you suddenly experience an increase in the size or number of floaters.
• If you have had eye surgery or are scheduled for eye surgery within the previous four weeks or the next four weeks.
• If you have a severe form of CRVO or BRVO (ischemic CRVO or ischemic BRVO), treatment with Eylea is not recommended.

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

• The safety and efficacy of Eylea when administered in both eyes simultaneously has not been studied, and using it in this way may increase the risk of adverse effects.
• Eylea injections may cause an increase in intraocular pressure in some patients within 60 minutes after injection. Your doctor will monitor you after each injection.
• If you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may experience eye pain or increased discomfort, worsening of eye redness, blurred or decreased vision, and increased sensitivity to light. It is important that any symptoms are diagnosed and treated as soon as possible.
• Your doctor will check whether you have other risk factors that may increase the likelihood of a tear or detachment of the back layers of the eye (retinal tear or detachment, or tear or detachment of the retinal pigment epithelium), in which case Eylea will be administered with caution.
• Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus.
• Women of childbearing potential must use effective contraception during treatment and for at least three months after the last Eylea injection.

Systemic use of VEGF inhibitors—substances similar to those contained in Eylea—is potentially associated with the risk of blood vessel blockage due to blood clots (arterial thromboembolic events), which may lead to myocardial infarction or stroke. After Eylea injection into the eye, there is a theoretical risk that such events may occur. Data on the safety of treating patients with CRVO, BRVO, mAMD, and myopic CNV who have experienced a stroke, transient ischemic attack (TIA), or myocardial infarction within the past 6 months are limited. If any of these apply to you, Eylea will be administered with caution.

Experience is limited in treating:

• Patients with DME due to type I diabetes.
• Diabetic patients with very high average blood sugar levels (glycated hemoglobin above 12%).
• Diabetic patients with an eye disease caused by diabetes, known as proliferative diabetic retinopathy.

There is no experience in treating:

• Patients with acute infections.
• Patients with other eye diseases such as retinal detachment or macular hole.
• Diabetic patients with uncontrolled hypertension.
• Non-Asian patients with myopic CNV.
• Patients previously treated for myopic CNV.
• Patients with damage outside the central part of the macula (extrafoveal lesions) due to myopic CNV.

If any of the above apply to you, your doctor will take this lack of information into account when deciding to treat you with Eylea.

Children and adolescents

The use of Eylea has not been studied in children and adolescents under 18 years of age for indications other than retinopathy of prematurity (ROP).

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 contraception during treatment and for at least three months after the last Eylea injection.
• There is no experience with the use of Eylea in pregnant women. Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant or planning to become pregnant, discuss this with your doctor before starting Eylea treatment.
• Small amounts of Eylea may pass into breast milk. The effects on newborns or breastfed infants are unknown. Eylea is not recommended during breastfeeding. If you are breastfeeding, discuss this with your doctor before starting Eylea treatment.

Driving and use of machines

After Eylea injection, you may experience temporary visual disturbances. Do not drive or operate machinery while these disturbances last.

Eylea contains

• less than 1 mmol of sodium (23 mg) per dose unit; this is essentially “sodium-free”.
• 0.015 mg of polysorbate 20 in each 0.05 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 to you

Eylea will be administered by a physician experienced in the administration of intraocular injections, under sterile conditions.

The recommended dose is 2 mg of aflibercept (0.05 ml).

Eylea is given as an injection into the eye (intravitreal injection).

Prior to the injection, your doctor will use a disinfectant eye wash to carefully clean your eye to prevent infection. Your doctor will also administer a local anesthetic to reduce or prevent any pain you might feel during the injection.

Exudative AMD

Patients with exudative AMD will receive monthly injections for the first three doses, followed by another injection after an additional two months.

Your doctor will then decide whether the treatment interval between injections can remain every two months or be gradually extended in increments of 2 or 4 weeks if your disease has stabilized. If your condition worsens, the interval between injections may be shortened.

Routine visits to your doctor between injections are not necessary unless your doctor advises otherwise or you experience any problems.

Macular edema secondary to RVO (branch or central)

Your doctor will determine the most appropriate treatment schedule for you. Your treatment will begin with a series of monthly Eylea injections.

The interval between two injections must not be less than one month.

Your doctor may decide to discontinue treatment with Eylea if you are not benefiting from continued therapy.

Treatment will continue with monthly injections until your disease stabilizes. You may require three or more monthly injections.

Your doctor will monitor your response to treatment and may continue therapy, gradually increasing the interval between injections to maintain disease stability. If your condition worsens with a longer treatment interval, your doctor will shorten the interval between injections.

Depending on your response to treatment, your doctor will determine the follow-up and treatment schedule.

Diabetic macular edema (DME)

Patients with DME will receive monthly injections for the first five consecutive doses, followed by an injection every two months.

The interval between treatments may be maintained every two months or adjusted based on your disease status as assessed by your doctor. Your doctor will determine the follow-up visit schedule.

Your doctor may decide to discontinue treatment with Eylea if it is determined that you are not benefiting from continued therapy.

Myopic choroidal neovascularization (mCNV)

Patients with mCNV will be treated with a single injection. Additional injections will only be given if examinations by your doctor show that your condition has not improved.

The interval between two injections must not be less than one month.

If your disease resolves and later recurs, your doctor may restart treatment.

Your doctor will determine the follow-up examination schedule.

Detailed instructions for use are provided at the end of this leaflet under “How to prepare and administer Eylea to adults.”

If a dose of Eylea is missed

Schedule a new appointment to be examined and receive your injection.

Discontinuation of Eylea treatment

Consult your doctor before stopping treatment.

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.

Allergic reactions (hypersensitivity) may potentially occur. These can be serious and require that you contact your doctor immediately.

With administration of Eylea, certain side effects affecting the eyes may occur due to the injection procedure. Some of these may be serious, including blindness, a serious infection or inflammation inside the eye (endophthalmitis), detachment, tear or bleeding of the light-sensitive layer at the back of the eye (retinal detachment or tear), clouding of the lens (cataract), bleeding in the eye (vitreous haemorrhage), detachment of the gel-like substance inside the eye in contact with the retina (vitreous detachment), and increased pressure inside the eye (see section 2). These serious eye-related side effects occurred in fewer than 1 out of 1,900 injections during clinical trials.

If you notice a sudden decrease in vision or increased pain and redness in the eye after the injection, contact your doctor immediately.

List of reported side effects

Below is a list of side effects reported as possibly related to the injection procedure or the medicine. Do not be alarmed, as you may not experience any of these. Always consult your doctor if you suspect any side effect.

Very common side effects (may affect more than 1 in 10 people):

• Vision impairment
• Bleeding at the back of the eye (retinal haemorrhage)
• Blood in the eye due to bleeding from small blood vessels in the outer layers of the eye
• Eye pain

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

• Detachment or tear of one of the layers at the back of the eye causing flashes of light with floating spots, which sometimes progresses to vision loss (tear/detachment of the retinal pigment epithelium, tear/detachment of the retina)

  • *Side effects known to be associated with neovascular (wet) AMD; observed only in patients with neovascular (wet) AMD.

• Degeneration of the retina (causing visual disturbances)

• Bleeding in the eye (vitreous haemorrhage)

• Certain forms of clouding of the lens (cataract)

• Damage to the surface layer of the eyeball (cornea)

• Increased pressure inside the eye

• Spots in vision (floaters)

• Detachment of the gel-like substance inside the eye from the retina (vitreous detachment, resulting in flashes of light and floaters)

• Sensation of having something in the eye

• Increased tear production

• Swelling of the eyelid

• Bleeding at the injection site

• Redness of the eye

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

• Allergic reactions (hypersensitivity)**
  • **Allergic reactions reported include rash, itching (pruritus), hives (urticaria), and some cases of serious allergic (anaphylactic/anaphylactoid) reactions.
• Inflammation or serious infection inside the eye (endophthalmitis)
• Inflammation of the iris or other parts of the eye (iritis, uveitis, iridocyclitis, floaters in the anterior chamber)
• Abnormal sensation in the eye
• Irritation of the eyelid
• Swelling of the surface layer of the eyeball (cornea)

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

• Blindness
• Clouding of the lens due to injury (traumatic cataract)
• Inflammation of the gel-like substance inside the eye
• Pus in the eye

Frequency not known (cannot be estimated from available data):

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

In clinical trials, an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage) was observed in patients with neovascular (wet) AMD who were receiving anticoagulant treatment. This increased incidence was comparable in patients treated with ranibizumab and with Eylea.

Systemic use of VEGF inhibitors—substances similar to those contained in Eylea—is potentially associated with the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or stroke. There is a theoretical risk that such events could occur following Eylea injection into the eye.

As with all therapeutic proteins, there is a possibility of an immune reaction (antibody formation) with Eylea.

Reporting of side effects

If you experience any side effect, talk to your doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed 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 which is 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.
• The unopened blister can be stored outside the refrigerator at temperatures below 25 °C for a maximum of 24 hours.
• Keep in the original packaging to protect from light.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eylea

• The active substance is: aflibercept. A pre-filled syringe contains a deliverable volume of at least 0.09 ml, equivalent to at least 3.6 mg of aflibercept. One pre-filled syringe provides a dose of 2 mg of aflibercept in 0.05 ml.
• The other components are: polysorbate 20 (E 432), monosodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injections.

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

Nature and contents of the container

Eylea is an injectable solution (injectable) in a pre-filled syringe. The solution is colourless to pale yellow.

Pack containing 1 pre-filled syringe.

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer responsible for production

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent 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/eylea1.

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

<------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

How to prepare and administer Eylea to adults

The pre-filled syringe must be used for the treatment of one eye only.

Do not open the sterile pre-filled syringe blister pack outside a clean room.

The pre-filled syringe contains a volume greater than the recommended dose of 2 mg aflibercept (equivalent to 0,05 ml). The excess volume must be discarded before administration.

Before administration, the solution should be inspected visually for the presence of particulate matter and/or discoloration or any change in physical appearance. If any of these are observed, do not use the medicinal product.

The unopened blister pack may be stored outside the refrigerator at temperatures below 25 °C for up to 24 hours. After opening the blister pack, proceed under aseptic conditions.

For intravitreal injection, a 30 G x ½ inch (1.27 cm) injection needle should be used.

Instructions for use of the pre-filled syringe:

Package leaflet: Information for carers of premature babies

Eylea 40mg/ml solution for injection in a pre-filled syringe

aflibercept

PREMATURE INFANTS

Read all of this leaflet carefully before this medicine is administered to the baby, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult the baby’s doctor.
• If you notice any symptoms of side effects, consult the baby’s doctor, even if they are symptoms or side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Eylea is and what it is used for

Eylea is a solution injected into the eye. Eylea belongs to a group of medicines called anti-angiogenesis agents. It contains the active substance aflibercept.

Eylea is used in premature infants to treat a condition called retinopathy of prematurity (ROP). Babies with ROP have abnormal growth of new blood vessels at the back of the eye (retina), caused by vascular endothelial growth factor (VEGF). This may lead to vision impairment and, in severe cases, permanent blindness.

Aflibercept, the active substance in Eylea, blocks the activity of a group of factors called vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF).

Eylea has been shown to stop the growth of abnormal new blood vessels in the eye, which often leak fluid or bleed. Eylea may help stabilize and, in many cases, improve vision loss caused by ROP.

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

Do not administer Eylea to the baby if

• the baby is allergic to aflibercept or to any of the other ingredients of this medicine (listed in section 6)
• the baby has an active infection or suspected infection in or around the eye (ocular or periocular infection)
• the baby has severe inflammation of the eye (indicated by pain or redness).

Warnings and precautions

Consult the baby’s doctor before Eylea is administered

• If the baby has undergone eye surgery or has scheduled eye surgery within the previous four weeks or the next four weeks.

Additionally, it is important to know that

• Eylea injections may cause an increase in pressure inside the eye (intraocular pressure) in some patients within 60 minutes after injection. The baby’s doctor will monitor this after each injection.
• If the baby develops an infection or inflammation inside the eye (endophthalmitis) or other complications, symptoms may include eye redness/irritation, eye discharge, eyelid swelling, and increased sensitivity to light. It is important that any symptoms are diagnosed and treated as soon as possible.

Inform the baby’s doctor immediately if any of the symptoms listed above occur.

• The baby’s doctor will check whether there are other risk factors that may increase the likelihood of a tear or detachment of one of the back layers of the eye (retinal tear or detachment), in which case Eylea will be administered with caution.

Systemic use of VEGF inhibitors, substances similar to those in Eylea, is potentially associated with the risk of blood vessel blockage due to blood clots (arterial thromboembolic events), which may lead to myocardial infarction or stroke. There is a theoretical risk that such events could occur after Eylea injection into the eye.

There is no experience in treating:

• Patients with acute infections.
• Patients with other eye conditions such as retinal detachment or macular hole.

If any of the above apply to the baby, the baby’s doctor will take this lack of information into account when deciding on treatment with Eylea.

Other medicines and Eylea

Inform the baby’s doctor if the baby is receiving, has recently received, or might need to receive any other medicines.

Eylea contains

• less than 1 mmol of sodium (23 mg) per dose unit; this is essentially “sodium-free”.
• 0.003 mg of polysorbate 20 in each 0.01 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 to the baby

Eylea will be administered into the baby’s eye(s) by a doctor experienced in administering intraocular injections, under sterile conditions.

The recommended dose is 0.4 mg of aflibercept (0.01 ml).

Eylea is given as an injection into the inside of the baby’s eye (intravitreal injection).

Before the injection, the baby’s doctor will use a disinfectant eye wash to carefully clean the baby’s eye to prevent infection. The doctor will also administer a local anaesthetic to reduce or prevent any pain the baby may feel during the injection.

Treatment begins with a single injection per eye and may be administered in the second eye on the same day. The baby’s doctor will monitor the condition of the eye(s). Depending on how the baby responds to treatment, the doctor will decide whether additional treatment is needed and when it should be given. The interval between two doses injected into the same eye should be at least 4 weeks.

Detailed instructions for use are provided at the end of this leaflet under “How to prepare and administer Eylea to premature infants”.

Discontinuation of Eylea treatment

If you are considering stopping treatment with Eylea, speak to the baby’s doctor at the next appointment. The doctor will advise you and decide how long the baby should continue treatment with Eylea.

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

4. Possible side effects

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

Side effects reported in more than one premature infant were

• detachment of the layer at the back of the eye (retinal detachment)
• bleeding at the back of the eye (retinal haemorrhage)
• bloodshot eye due to bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage)
• bleeding at the injection site (injection site haemorrhage)
• increased eye pressure
• eyelid swelling (eyelid oedema)

The following other side effects have been observed with Eylea in adults. These side effects may also occur in premature infants:

• allergic reactions (hypersensitivity).

These may be serious and require immediate contact with the baby’s doctor.

Side effects affecting the eyes due to the injection procedure may be serious, including

• blindness
• severe infection or inflammation inside the eye (endophthalmitis)
• detachment, tear, or bleeding of the light-sensitive layer at the back of the eye (retinal detachment or tear)
• clouding of the lens (cataract)
• bleeding in the eye (vitreous haemorrhage)
• detachment of the gel-like substance inside the eye in contact with the retina (vitreous detachment)
• increased pressure inside the eye (increased intraocular pressure), see section 2.

These serious eye-related side effects occurred in fewer than 1 in 1,900 injections during clinical trials in adults.

It is important to identify and treat serious side effects such as an infection inside the eye or retinal detachment as soon as possible.

Inform the baby’s doctor immediately if you notice any symptoms in the baby’s eye after the injection, for example

• redness/irritation
• eye discharge
• eyelid swelling
• increased sensitivity to light

The following side effects have been observed in adults.

List of reported side effects

Below is a list of side effects reported as possibly related to the injection procedure or the medicine. Do not be alarmed, as the baby may not experience any of them. Always consult the baby’s doctor about any suspected side effect.

Very common side effects (may affect more than 1 in 10 people):

• worsening of vision
• bleeding at the back of the eye (retinal haemorrhage)
• blood in the eye due to bleeding from small blood vessels in the outer layers of the eye
• eye pain

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

• detachment or tear of one of the back layers of the eye causing flashes of light with floating spots, sometimes progressing to vision loss (tear/detachment of retinal pigment epithelium, retinal tear/detachment)

• *Side effects known to be associated with exudative AMD; observed only in patients with exudative AMD.

• degeneration of the retina causing vision disturbances

• bleeding in the eye (vitreous haemorrhage)

• certain forms of lens clouding (cataract)

• damage to the surface layer of the eyeball (the cornea)

• increased pressure inside the eye

• spots in vision (floaters)

• detachment of the gel-like substance inside the eye from the retina (vitreous detachment, resulting in flashes of light and floaters)

• sensation of a foreign body in the eye

• increased tear production

• eyelid swelling

• bleeding at the injection site

• eye redness

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

• allergic reactions (hypersensitivity)**

• ** Allergic reactions reported include rash, itching (pruritus), hives (urticaria), and some cases of severe allergic (anaphylactic/anaphylactoid) reactions.

• inflammation or severe infection inside the eye (endophthalmitis)

• inflammation of the iris or other parts of the eye (iritis, uveitis, iridocyclitis, anterior chamber cells)

• abnormal sensation in the eye

• eyelid irritation

• swelling of the surface layer of the eyeball (cornea)

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

• blindness
• lens clouding due to injury (traumatic cataract)
• inflammation of the gel-like substance inside the eye
• pus in the eye

Frequency not known (cannot be estimated from available data):

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

Systemic use of VEGF inhibitors, substances similar to those in Eylea, is potentially associated with the risk of blood clots blocking blood vessels (arterial thromboembolic events), which may lead to heart attack or embolism. There is a theoretical risk that such events could occur after Eylea injection into the eye.

As with all therapeutic proteins, there is a possibility of an immune reaction (antibody formation) with Eylea.

If you have any questions about a side effect, ask the baby’s doctor.

Reporting of side effects

If you notice any side effects in the baby, consult the baby’s doctor, even if they are possible side effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting side effects, you 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 stated on the carton and label after “CAD/EXP”. The expiry date refers to the last day of that month.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• The unopened blister pack may be kept outside the refrigerator at temperatures below 25 °C for up to 24 hours.
• Keep in the original packaging to protect from light.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

Composition of Eylea

• The active substance is: aflibercept. A pre-filled syringe contains a minimum extractable volume of 0.09 ml, equivalent to at least 3.6 mg of aflibercept. A pre-filled syringe provides a single dose of 0.4 mg aflibercept in 0.01 ml.

• The other ingredients are: polysorbate 20 (E 432), monosodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injections.

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

What Eylea looks like and contents of the pack

Eylea is a solution for injection (injectable) in a pre-filled syringe. The solution is colourless to pale yellow.

Pack containing 1 pre-filled syringe.

Marketing Authorisation Holder

Bayer AG
51368 Leverkusen
Germany

Manufacturer

Bayer AG
Müllerstraße 178
13353 Berlin
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this package leaflet:

Other sources of information

Detailed information on this medicine 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/eylea1.

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

<------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

How to prepare and administer Eylea in preterm newborns

The pre-filled syringe must be used for the treatment of one eye only. Withdrawing multiple doses from a single pre-filled syringe may increase the risk of contamination and subsequent infection.

Do not open the sterile pre-filled blister outside a clean room. Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.

The pre-filled syringe contains more volume than the recommended dose of 0.4 mg aflibercept (equivalent to 0.01 ml). For the treatment of preterm newborns, the pediatric dosing device PICLEO must be used in combination with the pre-filled syringe to administer a single dose of 0.4 mg aflibercept (equivalent to 0.01 ml). See the following section "Instructions for use of the pre-filled syringe".

Before administration, the solution should be visually inspected for the presence of particles and/or discoloration or any change in physical appearance. If any of these are observed, do not use the medicine.

The unopened blister may be stored outside the refrigerator below 25 °C for up to 24 hours. After opening the blister, proceed under aseptic conditions.

For intravitreal injection, a 30 G x ½ inch (1.27 cm) injection needle must be used.

Instructions for use of the pre-filled syringe:

To prepare the pre-filled syringe for administration in preterm newborns, follow steps 1 and 2 described below, and then follow the instructions for use provided in the packaging of the pediatric dosing device PICLEO.

1. When ready to administer Eylea, open the carton and remove the sterilized blister. Carefully peel off the blister lid, maintaining sterility of the contents. Keep the syringe in the sterile tray until ready for assembly.
2. Using an aseptic technique, remove the syringe from the sterilized blister packaging.