Active ingredient
- aflibercept
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/12/797/002.
Eylea 40mg/ml solution for injection in a vial
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package Leaflet: Information for the patient
Eylea 40 mg/mL solution for injection in a vial
aflibercept
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What Eylea is and what it is used for
2. What you need to know before you are given Eylea
3. How you will be given Eylea
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 which is injected into the eye to treat eye conditions in adults called
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 wet AMD and myopic CNV, these factors, in excess are involved in the abnormal formation of new blood vessels in the eye. These new blood vessels can cause the leak of blood components into the eye and eventual damage to tissues in the eye responsible for vision.
In patients with CRVO, a blockage occurs in the main blood vessel that transports blood away from the retina. VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing a swelling of the macula, (the portion of the retina responsible for fine vision), which is called macular oedema. When the macula swells with fluid, central vision becomes blurry.
In patients with BRVO, one or more branches of the main blood vessel that transports blood away from the retina is blocked. VEGF levels are elevated in response causing the leakage of fluid into the retina and thereby causing macular oedema.
Diabetic macular oedema is a swelling of the retina occurring in patients with diabetes due to leaking of fluid from blood vessels within the macula. The macula is the portion of retina responsible for fine vision. When the macula swells with fluid, central vision becomes blurry.
Eylea has been shown to stop the growth of new abnormal blood vessels in the eye which often leak fluid or bleed. Eylea can help to stabilise, and in many cases, improve the vision loss related to wet AMD, CRVO, BRVO, DME and myopic CNV.
2. What you need to know before you are given Eylea
You will not be given Eylea
Warnings and precautions
Talk to your doctor before you are given Eylea:
Furthermore, it is important for you to know that:
The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke. There is a theoretical risk of such events following injection of Eylea into the eye. There are limited data on safety in treating patients with CRVO, BRVO, DME and myopic CNV who have had a stroke or a mini-stroke (transient ischaemic attack) or a heart attack within the last 6 months. If any of these apply to you, Eylea will be given with caution.
There is only limited experience in the treatment of
There is no experience in the treatment of
If any of the above applies to you, your doctor will consider this lack of information when treating you with Eylea.
Children and adolescents
The use of Eylea in children or adolescents under 18 has not been studied because wet AMD, CRVO, BRVO, DME and myopic CNV 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
Driving and using machines
After your injection with Eylea, you may experience some temporary visual disturbances. Do not drive or use machines as long as these last.
Important information about some of the ingredients of Eylea
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ’sodium-free’.
3. How you will be given Eylea
A doctor experienced in giving eye injections will inject Eylea into your eye under aseptic (clean and sterile) conditions.
The recommended dose is 2 mg aflibercept (50 microlitres).
Eylea is given as an injection into your eye (intravitreal injection).
Before the injection your doctor will use a disinfectant eyewash to clean your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
wet AMD
Patients with wet AMD will be treated with one injection per month for three consecutive doses, followed by another injection after a further two months.
Your doctor will then decide whether the treatment interval between injections may be kept at every two months or be gradually extended in 2- or 4-weekly intervals if your condition has been stable. If your condition worsens, the interval between injections can be shortened, but to not less than every two months in the first year of treatment.
Unless you experience any problems or are advised differently by your doctor, there is no need for you to see your doctor between the injections.
Macular oedema secondary to RVO (branch RVO or central RVO)
Your doctor will determine the most appropriate treatment schedule for you. You will start your treatment with a series of monthly Eylea injections.
The interval between two injections should not be shorter than one month.
Your doctor may decide to stop treatment with Eylea, if you are not benefiting from continued treatment.
Your treatment will continue with monthly injections until your condition is stable. Three or more monthly injections may be needed.
Your doctor will monitor your response to treatment and may continue your treatment by gradually increasing the interval between your injections to maintain a stable condition. If your condition starts to worsen with a longer treatment interval, your doctor will shorten the interval accordingly.
Based on your response to treatment your doctor will decide on the schedule for follow up examinations and treatments.
Diabetic macular oedema (DME)
Patients with DME will be treated with one injection per month for the first five consecutive doses followed by one injection every two months thereafter.
Unless you experience any problems or are advised differently by your doctor, there is no need for you to see your doctor between the injections.
After the first 12 months of treatment with Eylea, the treatment interval may be extended based on your doctor’s examination. Your doctor will decide on the schedule for follow up examinations.
Your doctor may decide to stop treatment with Eylea if it is determined that you are not benefiting from continued treatment.
Myopic CNV
Patients with myopic CNV will be treated with one single injection. You will receive further injections only if your doctor’s examinations reveal that your condition has not improved.
The interval between two injections should not be shorter than one month.
If your condition goes away and then comes back, your doctor may re-start the treatment.
Your doctor will decide on the schedule for follow up examinations.
If a dose of Eylea is missed
Make a new appointment for an examination and injection.
Stopping treatment with Eylea
Consult your doctor before stopping the treatment.
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.
Allergic reactions (hypersensitivity) could potentially occur. These may be serious and require that you contact your doctor immediately.
With administration of Eylea, there may be some side effects affecting the eyes which are due to the injection procedure. Some of these may be serious and include 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 from the retina (vitreous detachment) and increase of pressure inside the eye, see section 2. These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections in clinical studies.
If you experience a sudden decrease in vision, or an increase in pain and redness in your eye after your injection, contact your doctor immediately.
List of side effects reported
The following is a list of the side effects reported to be possibly related to the injection procedure or to the medicine. Please do not get alarmed, you might not experience any of these. Always discuss any suspected side effects with your doctor.
Very common side effects(may affect more than 1 in 10 people):
Common side effects(may affect up to 1 in 10 people):
* Conditions known to be associated with wet AMD; observed in wet AMD patients only.
Uncommon side effects(may affect up to 1 in 100 people):
** Allergic reactions like rash, itching (pruritus), hives (urticaria), and a few cases of severe allergy (anaphylactic/anaphylactoid) reactions were reported.
Rare side effects(may affect up to 1 in 1,000 people):
In the clinical trials, there was an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival haemorrhage) in patients with wet AMD receiving blood thinners. This increased incidence was comparable between patients treated with ranibizumab and Eylea.
The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially related to the risk of blood clots blocking blood vessels (arterial thromboembolic events) which may lead to heart attack or stroke. There is a theoretical risk of such events following injection of Eylea into the eye.
As with all therapeutic proteins, there is a possibility for an immune reaction (formation of antibodies) with Eylea.
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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
Malta
5. How to store Eylea
6. Contents of the pack and other information
What Eylea contains
What Eylea looks like and contents of the pack
Eylea is a solution for injection (injection) in a vial (4 mg/100 microlitres). The solution is colourless to pale yellow.
Pack size of 1.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 09/2020
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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+44 (0)118 206 3000