Afqlir is a solution that is injected into the eye to treat eye conditions in adults called:
- age-related macular degeneration (AMD) neovascular (wet) form,
- visual acuity impairment caused by macular edema secondary to retinal vein occlusion (branch RVO (BRVO) or central RVO),
- visual acuity impairment caused by diabetic macular edema (DME),
- visual acuity impairment caused by myopic choroidal neovascularization (myopic CNV).

Aflibercept, the active substance in Afqlir, blocks the activity of a group of factors, known as VEGF-A (Vascular Endothelial Growth Factor A) and PlGF (Placental Growth Factor).

In patients with wet AMD and myopic CNV, these factors, when present in excess, are involved in the abnormal formation of new blood vessels in the eye. These new blood vessels can cause blood components to leak into the eye and eventually damage the tissues responsible for vision in the eye.

In patients with CRVO, there is a blockage of the main blood vessel that carries blood from the retina. In response, VEGF levels are increased, which leads to fluid leaking into the retina and, consequently, causes the macula (the part of the retina responsible for fine vision) to swell, a condition called macular edema. When the macula swells with fluid, central vision becomes blurred.
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In patients with ORVR, one or more branches of the main blood vessels that carry blood away from the retina are blocked. In response, VEGF levels are increased, causing fluid to leak from the retina and thus causing macular edema.

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

Afqlir has been shown to stop the growth of new, abnormal blood vessels in the eyes, which often cause fluid leakage or bleeding. Afqlir can help stabilize and, in most cases, improve vision loss associated with wet AMD, CRVO, VRRO, DME, and myopic CNV.

You should not be given Afqlir:
- if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before you are given Afqlir.

Pregnancy and breastfeeding:
- Women of childbearing potential must use effective contraception during treatment and for at least three months after the last Afqlir injection.

- There is no experience with aflibercept in pregnant women. Afqlir 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 Afqlir.

- Small amounts of Afqlir may pass into human milk. The effects on breastfed newborns/infants are unknown. Afqlir is not recommended during breast-feeding. If you are a breast-feeding woman, tell your doctor before starting treatment with Afqlir.

Driving and using machines:
After injecting Afqlir you may have some temporary vision changes. While these persist, do not drive or use machines.

Afqlir contains:
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
This medicine contains 0.02 mg polysorbate 20 per delivered dose of 0.05 ml (50 microlitres) of solution. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

An ophthalmologist experienced in giving injections into the eye will inject Afqlir into your eye under aseptic conditions (in a clean and sterile environment).

The recommended dose is 2 mg aflibercept (0.05 ml).
Afqlir is given as an injection into the eye (intravitreal injection).

Before the injection, your doctor will use a disinfectant eye wash solution to thoroughly clean your eye and prevent infection. Your doctor will also give you a local anesthetic to reduce or prevent any pain you may feel during the injection.

Wet AMD
Patients with wet AMD will be given an injection once a month for 3 consecutive doses, followed by another injection two months later.

Your doctor will then decide whether the treatment interval between injections will be maintained at every two months or gradually extended to 2 or 4 week intervals, if your condition is stable.

If your condition worsens, the interval between injections may be shortened.

Unless you have any problems or are advised differently by your healthcare provider, there is no need to see your doctor between injections.

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

Your doctor will determine the most appropriate treatment schedule for you. You will start treatment with a series of injections of Afqlir, an injection given monthly, for several consecutive months.
The interval between two injections should not be less than one month.

Your doctor may decide to stop treatment with Afqlir if you are not benefiting from continued treatment.

Your treatment will continue with monthly injections until your condition is stable. 3 or more injections may be needed, given consecutively, 1 injection per month.

Your doctor will monitor your response to treatment and may continue treatment by gradually increasing the interval between injections to maintain a stable condition. If your condition begins to worsen following treatment administered at a longer interval, your doctor will decide - as appropriate - to shorten the treatment interval.

Depending on your response to treatment, your doctor will decide on a follow-up schedule, including examinations and treatments.

Diabetic macular edema (DME)
Patients with EMD will receive one injection once a month for five consecutive administrations, then one injection every two months.

The treatment interval can be kept at 2 months or adjusted to your disease, based on the examination performed by your doctor. Your doctor will decide the schedule of follow-up examinations.

Your doctor may decide to stop treatment with Afqlir if they determine that you are not benefiting from continuing treatment.

Myopic CNV
Patients with myopic CNV were treated with a single injection. You will only be given additional injections if your doctor's examinations show that your condition has not improved.

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

If your condition goes away and comes back, your doctor may restart your treatment.

Your doctor will schedule follow-up examinations.

Detailed instructions for use are provided at the end of the leaflet, under “Instructions for use of the pre-filled syringe”.

If you have any further questions on this medicine, ask your doctor.

- The active substance is: aflibercept. Each pre-filled syringe contains 6.6 mg aflibercept in 0.165 ml of solution. This provides a usable amount for the administration of a single dose of 0.05 ml, containing 2 mg aflibercept.
- The other ingredients are: polysorbate 20 (E 432), histidine, L-histidine monohydrochloride monohydrate, trehalose dihydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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