40 mg/ml solution for injection in a vial of 
aflibercept

1. What Eylea is and what it is used for

Eylea is a solution that is injected into the eye to treat eye diseases in adults called

  • neovascular (wet) age-related macular degeneration (wet AMD)
  • impaired vision due to macular edema secondary to retinal venous occlusion (BRVO) or central venous occlusion (CRVO))
  • impaired vision due to diabetic macular edema (DME)
  • impaired vision due to myopic choroidal neovascularization (myopic CNV).

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 (P1GF).

In patients with wet AMD and myopic CNV, an excess of these factors contributes to an abnormal formation of new blood vessels in the eye. These new blood vessels can lead to leakage of blood components in the eye and possibly cause damage to the tissues that are responsible for vision.

In patients with CRVO, a blockage occurs in the large blood vessel that transports blood from the retina (retina). VEGF levels increase as a reaction to this, which leads to leakage of fluid to the retina and thus causes swelling of the macula (the part of the retina that is responsible for detailed vision), which is called macular edema. When the macula swells up with fluid, the central vision becomes blurred.

In patients with BRVO, a blockage occurs in one or more branches of the large blood vessel that transports blood from the retina (retina). VEGF levels increase as a reaction to this, which leads to leakage of fluid to the retina and thus causes macular edema.

Diabetic macular edema is a swelling of the retina that affects patients with diabetes due to fluid leaking from the blood vessels in the macula ( yellow spot ). The macula is the part of the retina that is responsible for visual acuity. When the macula swells up with fluid, the vision becomes blurred.

Eylea has been shown to stop the growth of new abnormal blood vessels in the eye that often leak fluid or bleed. Eylea can stabilize and in many cases improve the vision loss in connection with wet AMD, CRVO, BRVO, DME, and myopic CNV.

2. What you need to know before you get Eylea

You must not be treated with Eylea

  • if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6)
  • if you have an active or suspected infection in or around the eye ( ocular or periocular infection )
  • if you have a severe inflammation of the eye (manifested by pain or redness ).

Warnings and cautions

Talk to your doctor before receiving Eylea:

  • if you have glaucoma ( glaucoma )
  • if you have previously seen flashes of light or dots/spots in the field of view and if you experience a sudden increase in the number and size of dots/spots
  • if an operation on the eye has been performed in the last four weeks or is planned within the next four weeks
  • if you have a severe form of CRVO or BRVO (ischemic CRVO or BRVO), Eylea treatment is not recommended.

Also, you must know that:

  • The safety and efficacy of Eylea have not been studied when administered in both eyes at the same time and may increase the risk of side effects if used in this way.
  • injection with Eylea may cause an increase in pressure in the eye ( intraocular pressure ) in some patients within 60 minutes after injection. Your doctor will check this after each injection
  • if you develop an infection or inflammation in the eye ( endophthalmitis ) or have other complications, you may experience eye pain or increased discomfort, worsening of reddening of the eyes, blurred or poorer vision, and increased sensitivity to light. All symptoms must be diagnosed and treated as soon as possible
  • your doctor will check if you have other risk factors that may increase the risk of rupture or detachment of one of the layers in the back of the eye (retinal detachment/rupture and rupture/detachment of the retinal pigment epithelium), in which case Eylea must be given with caution
  • Eylea should not be used during pregnancy unless the potential benefit justifies the potential risk to the unborn baby.
  • fertile women should use effective contraception during treatment and for at least 3 months after the last injection of Eylea.

Systemic use of VEGF inhibitors, substances similar to those found in Eylea, is optionally associated with an increased risk of blood clots that block the blood vessels (arterial thromboembolic events) and can lead to myocardial infarction or stroke ( stroke ). There is a theoretical risk of such events after injection into the eye with Eylea. There are limited data on the safety of patients with CRVO, BRVO, DME, and myopic CNV who have had a stroke or a ministroke ( transient ischemic attack) or a heart attack in the last 6 months. If any of these apply to you, Eylea should be given with caution.

There is only limited experience in the treatment of:

  • patients with DME due to type I diabetes
  • diabetic patients with very high mean blood glucose levels ( HbA1c above 12%)
  • diabetic patients with an eye disease caused by diabetes called proliferative diabetic retinopathy.

There is no experience in the treatment of:

  • patients with acute infection are
  • patients with other eye diseases, e.g. retinal detachment or macular holes
  • patients with uncontrolled hypertension
  • non-Asian patients with myopic CNV
  • patients previously treated for myopic CNV
  • myopic CNV in patients with damage outside the central part of the macula(extrafoveal lesion s).

If any of the above apply to you, your doctor will consider this lack of information when you are being treated with Eylea.

Children and young people

The use of Eylea in children and adolescents under 18 years of age has not been studied as wet AMD, CRVO, BRVO, DME, and myopic CNV mainly affect adults. Therefore, use in this age group is not relevant.

Other medicines and Eylea

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

Pregnancy and breastfeeding

  • Women of childbearing potential should use effective contraception during treatment and for at least 3 months after the last injection of Eylea.
  • There is no experience with the use of Eylea in pregnant women. Eylea should not be used during pregnancy unless the potential benefit justifies the potential risk to the unborn baby. If you are pregnant or planning to have a baby, talk to your doctor before taking Eylea.
  • Eylea is not recommended for breast-feeding because it is not known if Eylea passes into breast milk. Ask your doctor for advice before starting treatment with Eylea.

Driving and using machines

After an injection of Eylea, you may experience temporary visual disturbances. Do not drive or use machines for as long as they remain.

Important information about some of the ingredients of Eylea

This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘sodium-free’.

3. How to get Eylea

A doctor with experience in giving eye injections will inject Eylea into the eye under aseptic (clean and sterile) conditions.

The recommended dose is 2 mg aflibercept (50 microliters). 
Eylea is given as an injection into the eye (intravitreal injection ).

Before injection, your doctor will use disinfectant eyewash to thoroughly clean your eye to prevent infection  Your doctor will also give you local anesthetics to reduce or prevent the pain you may experience with injection one.

Wet AMD

Patients with wet AMD are treated with one injection a month for three consecutive months and then receive another injection after another two months.

Your doctor will then decide if the treatment interval with an injection every two months can remain or if the interval should be gradually increased by 2 or 4 weeks if your condition has been stable. If your condition worsens, the interval between injections may be shortened.

If you do not experience any problems or have received any other advice from your doctor, you do not need to visit your doctor between injections.

Macular edema secondary to RVO (branch vein occlusion or central vein occlusion)

Your doctor will decide which treatment plan is most suitable for you. Your treatment will start with an Eylea injection once a month.

The interval between two injections should not be shorter than one month.

Your doctor may decide to stop your treatment with Eylea if you have no benefit from continuing treatment.

Treatment should be continued with an injection once a month until the condition is stable. Three or more injections may be needed.

Your doctor will monitor how you respond to treatment and can continue your treatment by gradually increasing the interval between injections to maintain a stable condition. If your condition begins to worsen with longer treatment intervals, your doctor may shorten the interval.

Based on how you respond to the treatment, the doctor decides on follow-up examinations and treatments.

Diabetic macular edema (DME)

Patients with DME are treated with one injection once a month for the first five doses and then one injection every two months.

If you do not experience any problems or have received any other advice from your doctor, you do not need to visit your doctor between injections.

After the first twelve months of treatment with Eylea, the treatment interval can be increased, based on the doctor’s assessment. The attending physician decides how often the control visits should take place.

If it is determined that you will not benefit from continued treatment, your doctor may decide to stop treatment with Eylea.

Myopia SK CNV

Patients with myopic CNV are treated with a single injection. You will only receive an additional injection if your doctor’s examination shows that your condition has not improved.

The interval between two injections should not be shorter than one month.

If your condition disappears and then returns, your doctor may start treatment again.

The attending physician decides how often the control visits should take place.

If you fail to give you a dose of Eylea

Book a new visit for examination and injection.

Before stopping treatment with Eylea

Contact a doctor before stopping treatment.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

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

When administering Eylea, there may be side effects that affect the eyes due to the injection procedure. Some of these can be serious and include blindness, a serious infection or inflammation of the eye ( endophthalmitis ), discharge, rupture or bleeding in the photosensitive layer in the back of the eye (retinal detachment or rupture ), clouding of the lens of the eye ( cataract ), bleeding in the eye (vitreous hemorrhage), the release of the gel-like substance in the eye from the retina(vitreous detachment) and increase in pressure in the eye, see section 2. These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical trials.

If you experience sudden deterioration of vision or an increase in pain and redness in the eye after injection, you should contact your doctor immediately.

List of reported side effect s

The following list is a list of side effects that have been reported and that may be related to the injection procedure or the medicine. Do not be afraid, you may not be affected by any of these. Always discuss suspected side effects with your doctor.

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

  • deterioration of vision
  • bleeding in the back of the eye (bleeding in the retina)
  • red eyes as a result of bleeding from small blood vessels in the outer layer of the eye ( conjunctival bleeding)
  • eye pain

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

  • discharge or rupture in one of the layers in the posterior part of the eye, which produces flashes of light with visual spots and can sometimes develop into a loss of vision (rupture * / detachment on the retinal pigment epithelium, retinal detachment/rupture)
  • retinal degeneration (which causes visual disturbance)
  • bleeding in the eye (vitreous hemorrhage)
  • certain types of clouding of the lens ( cataract )
  • damage to the anterior layer of the eyeball (cornea)
  • increased pressure in the eye
  • moving spots in the field of view (clouds)
  • a detachment of the gel-like substance in the eye from the retina (vitreous detachment that causes flashes of light with visual spots)
  • the feeling of having something foreign in the eye
  • increased tear flow
  • swollen eyelids
  • bleeding at the injection site
  • Red eyes

* Conditions associated with wet AMD only observed in patients with wet AMD

Less common side effects are (may affect up to 1 in 100 people):

  • allergic reactions (hypersensitivity) **
  • severe inflammation or infection of the eye ( endophthalmitis )
  • inflammation of the iris or other parts of the eye ( iritis, uveitis, iridocyclitis, light pathway in the anterior chamber)
  • abnormal sensation in the eye
  • eyelid irritation
  • swelling of the anterior layer of the eyeball (corneal edema)** Allergic reactions such as rash, itching ( pruritus ), hives ( urticaria ) and some cases of severe allergic (anaphylactic/anaphylactoid) reactions have been reported.

Rare side effects are (may affect up to 1 in 1000 people):

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

In clinical trials, an increased incidence of bleeding from small blood vessels in the outer layer of the eye ( conjunctival hemorrhage) has been reported in patients with wet AMD receiving blood thinners. The increased incidence was similar between patients treated with ranibizumab and Eylea.

Systemic use of VEGF inhibitors, compounds similar to those found in Eylea, are possibly associated with an increased risk of blood clots that block blood vessels (arterial thromboembolic events) and it can lead to a heart attack or stroke ( stroke ). There is a theoretical risk of such events after the injection of Eylea into the eye.

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

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 expiration date is the last day of the specified month.
  • Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
  • The unopened vial can be stored outside the refrigerator, at a maximum of 25 ° C.for up to 24 hours.
  • Store in the original package. Sensitive to 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 will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aflibercept. Each vial contains 100 microliters, equivalent to 4 mg aflibercept. One vial provides a dose of 2 mg aflibercept in 50 microliters.
  • The other ingredients are polysorbate 20 (E 432), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injections.

What the medicine looks like and the contents of the pack

Eylea is an injection solution ( injection ) in a vial (4 mg / 100 microliters). The solution is colorless to pale yellow.

Pack size of 1 vial + 1 filter needle.

Marketing Authorisation Holder

Bayer AG 
51368 Leverkusen 
Germany

Manufacturer 
Bayer AG 
Müllerstraße 178 
13353 Berlin 
Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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