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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 severe inflammation of the eye (indicated by pain or redness).

Talk to your doctor before you are given Eydenzelt

• if you have glaucoma.
• if you have a history of seeing flashes of light or floaters and if you have a sudden increase of size and number of floaters.
• if surgery was performed or is planned on your eye within the previous or next four weeks.
• if you have a severe form of CRVO or BRVO (ischaemic CRVO or BRVO), treatment with Eydenzelt is not recommended.

Furthermore, it is important for you to know that

• the safety and efficacy of Eydenzelt when administered to both eyes at the same time has not been studied and if used in this way may lead to an increased risk of experiencing side effects.
• injections with Eydenzelt may cause an increase in eye pressure (intraocular pressure) in some patients within 60 minutes of the injection. Your doctor will monitor this after each injection.
• if you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may have eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, and increased sensitivity to light. It is important to have any symptoms diagnosed and treated as soon as possible.
• your doctor will check whether you have other risk factors that may increase the chance of a tear or detachment of one of the layers at the back of the eye (retinal detachment or tear, and retinal pigment epithelial detachment or tear), in which case Eydenzelt must be given with caution.
• Eydenzelt should not be used in pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
• women of childbearing potential have to use effective contraception during treatment and for at least three further months after the last injection of Eydenzelt.

The systemic use (injecting directly into the bloodstream) of VEGF inhibitors, substances similar to those contained in Eydenzelt, 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 Eydenzelt 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, Eydenzelt will be given with caution.

There is only limited experience in the treatment of

• patients with DME due to type I diabetes.
• diabetics with very high average blood sugar values (HbA1c over 12%).
• diabetics with an eye disease caused by diabetes called proliferative diabetic retinopathy.

There is no experience in the treatment of

• patients with acute infections.
• patients with other eye conditions such as a detachment of the retina or a hole in the macula.
• diabetics with uncontrolled high blood pressure.
• non-Asian patients with myopic CNV.
• patients previously treated for myopic CNV.
• patients with damage outside the central part of the macula (extrafoveal lesions) for myopic CNV.

If any of the above applies to you, your doctor will consider this lack of information when treating you with Eydenzelt.

The use of Eydenzelt in children and adolescents under 18 years of age has not been studied.

Tell your doctor if you are using, have recently used or might use any other medicines.

• Women of childbearing potential have to use effective contraception during treatment and for at least three further months after the last injection of Eydenzelt.
• There is no experience of using Eydenzelt in pregnant women. Eydenzelt should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant or planning to become pregnant, discuss this with your doctor before treatment with Eydenzelt.
• Small amounts of Eydenzelt may pass into human milk. The effects on breast-fed newborns/infants are unknown. Eydenzelt is not recommended during breastfeeding. If you are a breastfeeding woman, discuss this with your doctor before treatment with Eydenzelt.

After your injection with Eydenzelt, you may experience some temporary visual disturbances. Do not drive or use machines as long as these last.

• less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
• 0.015 mg of polysorbate 20 in each 0.05 mL per dose, which is equivalent to 0.3 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Make a new appointment for an examination and injection.

Consult your doctor before stopping the treatment.

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):

• deterioration of eyesight
• bleeding in the back of the eye (retinal haemorrhage)
• bloodshot eye caused by 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 in the back of the eye, resulting in flashes of light with floaters sometimes progressing to a loss of vision (retinal pigment epithelial tear*/detachment, retinal detachment/tear)
  • * observed in patients with wet AMD
• degeneration of the retina causing disturbed vision
• bleeding in the eye (vitreous haemorrhage)
• certain forms of clouding of the lens (cataract)
• damage to the front layer of the eyeball (the cornea)
• increase in eye pressure
• moving spots in vision (floaters)
• detachment of the gel-like substance inside the eye from the retina (vitreous detachment, resulting in flashes of light with floaters)
• a feeling 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)**
  • ** rash, itching, hives, and a few cases of severe allergy (anaphylactic/anaphylactoid) reactions were reported.
• serious inflammation or infection inside the eye (endophthalmitis)
• inflammation in the iris or other parts of the eye (iritis, uveitis, iridocyclitis, anterior chamber flare)
• abnormal sensation in the eye
• eyelid irritation
• swelling of the front 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

Not known (frequency cannot be estimated from the available data):

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

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 aflibercept.

The systemic use (injecting directly into the bloodstream) of VEGF inhibitors, substances similar to those contained in Eydenzelt, 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 Eydenzelt into the eye.

As with all therapeutic proteins, there is a possibility for an immune reaction (formation of antibodies) with Eydenzelt.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is: aflibercept. One pre-filled syringe contains an extractable volume of at least 0.09 mL, equivalent to at least 3.6 mg aflibercept. One pre-filled syringe delivers a dose of 2 mg aflibercept in 0.05 mL.
• The other ingredients are: polysorbate 20 (E 432), Histidine (for pH adjustment), histidine hydrochloride monohydrate (for pH adjustment), sodium chloride, trehalose, water for injections.

See ‘Eydenzelt contains’ in section 2 for more information.

Eydenzelt is a solution for injection (injection) in a pre-filled syringe. The solution is clear to slightly opalescent, and colourless to very pale brownish-yellow.

Pack size of 1 pre-filled syringe.