PACKAGE LEAFLET: INFORMATION FOR THE USER

ILUVIEN, 190 micrograms, intravitreal implant in applicator
(Fluocinolone acetonide)
Please read all of this leaflet carefully before receiving the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet contents

What ILUVIEN implant is and what it is used for
Important information before receiving ILUVIEN implant
How ILUVIEN implant is administered
Possible side effects
How to store ILUVIEN implant
Contents of the pack and other information

1. WHAT ILUVIEN IMPLANT IS AND WHAT IT IS USED FOR

ILUVIEN is a tiny tube that is inserted into the eye and releases very small amounts of the active substance, fluocinolone acetonide, over a period of up to 3 years. Fluocinolone acetonide belongs to a group of medicines called corticosteroids.
ILUVIEN is used to treat vision loss associated with diabetic macular oedema when other available treatments are not effective. Diabetic macular oedema is a condition occurring in some people with diabetes and causes damage to the light-sensitive layer at the back of the eye responsible for central vision – the macula.
The active substance (fluocinolone acetonide medicine) helps reduce inflammation and swelling occurring in the macula in this condition. Therefore, ILUVIEN may help treat vision disturbances or prevent further worsening of vision.
ILUVIEN is used to prevent recurrences of posterior uveitis. Inflammation may cause vitreous floaters appearing as black spots or hazy lines moving across the patient's field of vision, or may lead to vision loss by damaging the part of the eye responsible for good vision, known as the "macula". Vision loss may persist if inflammation is not treated. ILUVIEN helps reduce inflammation and the associated swelling that may develop at the back of the eye. It may help improve the patient's vision or prevent its deterioration. It may also help prevent future inflammatory episodes.

2. IMPORTANT INFORMATION BEFORE RECEIVING ILUVIEN IMPLANT

When not to use ILUVIEN implant:

If the patient is allergic to fluocinolone acetonide or to any of the other components of this medicine (listed in section 6).
If there is any type of infection in or around the eye.
If glaucoma (high pressure inside the eye) is present.

Warnings and precautions

Before starting treatment with ILUVIEN implant, discuss with the doctor if:
- The patient is taking anticoagulant medicines;
The patient has previously had a herpes simplex virus infection (Herpes simplex) in the eye (long-standing corneal ulcer).
- ILUVIEN implant is administered by injection into the eye. Occasionally, the injection may cause an infection inside the eye, eye pain and redness, or retinal detachment or tear. It is important to diagnose and treat these conditions as quickly as possible. The patient should contact the doctor immediately if severe eye pain or discomfort, increasing eye redness, flashes of light, sudden increase in floaters, partial loss of vision, blurred or worsened vision, increased sensitivity to light, or any other visual disturbances occur after the injection.
- In some patients, eye pressure may increase, possibly leading to the development of glaucoma. This may go unnoticed; therefore, the patient must be monitored by the treating physician during clinic visits.
- In most patients who have not previously undergone cataract surgery, clouding of the eye's natural lens (cataract) may occur as a result of treatment with ILUVIEN implant. If this occurs, vision will deteriorate and cataract surgery will likely be required. The treating physician will help determine the best time for the procedure, but it should be understood that vision may remain poor or worsen until surgery is performed.
- The use of ILUVIEN implant injected into both eyes at the same time has not been studied and is not recommended. The treating physician should not administer ILUVIEN implants into both eyes simultaneously.
- There is a risk of the ILUVIEN implant moving from the back to the front of the eye. The risk is higher in patients who have previously undergone cataract surgery. Symptoms of implant displacement to the front of the eye may include distorted vision or other visual disturbances, swelling of the eye surface (corneal edema), or the patient may notice a change in the appearance of the eye from the front. If unexpected symptoms occur that may indicate implant displacement, the doctor should be informed immediately.
- In patients with posterior uveitis, a decrease in intraocular pressure may occur, which usually lasts for several days after injection. The patient may not notice this, therefore monitoring by the physician is required for 2 to 8 days and during subsequent clinic visits.

Children and adolescents (under 18 years of age)
The use of ILUVIEN implant in children and adolescents has not been studied and is therefore not recommended.
ILUVIEN implant and other medicines
Inform the doctor about all medicines currently taken or recently taken, including those obtained without a prescription.
Pregnancy, breastfeeding and fertility

There are limited data on the use of ILUVIEN implant in pregnant or breastfeeding women; therefore, potential risk is unknown.
There are no data on the effect on fertility. Since ILUVIEN implant is injected directly into the eye, an effect on fertility in men or women is unlikely.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before initiating treatment with ILUVIEN implant.

Driving and using machines
Blurred vision may occur temporarily after administration of ILUVIEN implant. If this occurs, the patient should not drive or operate machinery until the disturbance resolves.

3. HOW ILUVIEN IMPLANT IS ADMINISTERED

The ILUVIEN implant will be injected by an ophthalmologist.
The ILUVIEN implant is administered as a single injection into the eye. After the injection, your doctor will regularly monitor your condition.
Before the injection, your doctor will apply antibiotic eye drops and thoroughly rinse the eye to prevent infection. Your doctor will also administer a local anesthetic to prevent pain associated with the injection.
Before and after the injection, your doctor may instruct you to use antibiotic eye drops to prevent any possible eye infection. You must strictly follow these instructions.
If the implant stops working and your doctor recommends it, another implant may be injected into the eye. This applies only to patients treated with ILUVIEN for diabetic macular edema.
If you have any further doubts regarding the use of this medicine, please consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ILUVIEN may cause adverse reactions, although not everyone will experience them.
When using the ILUVIEN implant, certain adverse reactions may occur, most commonly affecting the eye. Occasionally, the injection may lead to an infection inside the eye, eye pain or redness, or retinal detachment or tear. It is important that these are diagnosed and treated as quickly as possible. You should immediately inform your doctor if you experience severe eye pain or discomfort, worsening eye redness, flashes of light, a sudden increase in floaters, partial loss of vision, worsening of vision, or increased sensitivity to light after the implant injection. Other adverse reactions include increased or decreased eye pressure and clouding of the eye's natural lens (cataract). Increased eye pressure, which can damage the optic nerve (glaucoma), is more likely if eye pressure was already above average before treatment. Your doctor will discuss the associated risks with you prior to treatment. Symptoms that may occur, and what to do if they occur, are described in section 2 of this leaflet (Warnings and precautions).

The following adverse reactions may occur after injection of the ILUVIEN implant:

Very common (occur in more than 1 in 10 patients)
Increased intraocular pressure, clouding of the eye's natural lens (cataract), or need for cataract surgery.

Common (occur in 1 to 10 out of 100 patients)
Increased intraocular pressure causing damage to the optic nerve (glaucoma), detachment of the light-sensitive layer at the back of the eye (retinal detachment), bleeding in the white part of the eye or inside the eye, small particles or spots in the visual field (vitreous floaters), sensation of seeing through fog or steam, decreased eye pressure causing sudden pain and blurred vision, loss of normal visual field, eye pain or irritation, worsening of vision, or need for an ophthalmic surgical procedure to reduce elevated eye pressure or remove the gel-like material filling the back of the eye, increased protein and cells in the front of the eye due to inflammation, sensation of a foreign body in the eye, dry eye.

Uncommon (occur in less than 1 in 100 patients)
Blockage of blood vessels at the back of the eye, growth of new blood vessels inside the eye, corneal ulcer in the white part of the eye, changes in the gel-like substance filling the back of the eye, clouding of the lens capsule, eye redness, itching or eye infection, reduced thickness of the outer white layer of the eye, eye injury due to injection, unintended displacement of the implant through the white part of the eye and/or other complications resulting from the injection, movement of the ILUVIEN implant from the back to the front of the eye, swelling of the eye surface (corneal edema), involuntary eyelid closure, eye pain with sudden attacks of severe pain, sometimes accompanied by blurred vision, deposits on the outer layer of the eye, painful eye condition caused by surface itching, eye swelling.

The most frequently reported non-ophthalmic adverse reaction, likely caused by the medicine or the injection procedure, is headache.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE ILUVIEN IMPLANT

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or immediate packaging after “Expiry date”.
Store below 30 °C.
Do not store in a refrigerator and do not freeze.
Do not open the foil-covered tray until immediately before use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
The used applicator should be safely disposed of in a biological hazard sharps container.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ILUVIEN implant contains

The active substance is fluocinolone acetonide.
Each intravitreal implant contains 190 micrograms of fluocinolone acetonide.
Other components: Excipients: polyvinyl alcohol. Excipients included in the implant: polyimide tube, silicone layer, polyvinyl alcohol.

What ILUVIEN looks like and contents of the pack
ILUVIEN consists of a tiny light brown tube (approximately 3.5 mm x 0.37 mm) placed in an
applicator system. The filled applicator is placed in a polycarbonate container and sealed with a removable cap. Each sealed container is supplied in a carton box which contains a patient leaflet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This medicinal product is authorised in the European Economic Area countries under the brand name "Iluvien":
Austria, Belgium, Czech Republic, Denmark, Finland, France, Spain, Netherlands, Ireland, Luxembourg, Germany, Norway, Poland, Portugal, Sweden, United Kingdom, Italy
Detailed and updated information on this medicine is available on the website:
www.urpl.gov.pl

Information intended exclusively for medical professionals:

INDICATIONS FOR USE
The ILUVIEN implant is indicated for:

the treatment of vision impairment associated with chronic diabetic macular edema insufficiently responsive to available therapies
prophylactic treatment of recurrent disease in the course of recurrent non-infectious posterior uveitis

CONTRAINDICATIONS
The ILUVIEN intravitreal implant is contraindicated in cases of concomitant glaucoma or active or suspected ocular or periocular infection, including most viral infections of the cornea and conjunctiva, such as active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella zoster, Mycobacterium infections, and fungal diseases.
The ILUVIEN implant is contraindicated in patients with:

hypersensitivity to the active substance or to any of the excipients
infectious uveitis

METHOD OF ADMINISTRATION
INTRAVITREAL ADMINISTRATION ONLY.
The ILUVIEN implant is intended solely for intravitreal administration and must be administered by an ophthalmologist experienced in performing intravitreal injections. The intravitreal injection procedure should be performed under controlled aseptic conditions, including sterile gloves, sterile drapes, and a sterile eyelid speculum (or equivalent). Prior to injection, appropriate anesthesia and a broad-spectrum antibacterial agent should be applied.
The ILUVIEN implant injection procedure should be performed as follows:

Antibiotic drops may be administered prior to the procedure at the discretion of the treating ophthalmologist.
Immediately before the procedure, local anesthesia should be applied at the injection site (the lower temporal quadrant is recommended), either by instilling one drop followed by application of a gauze-wrapped applicator soaked in anesthetic agent, or by subconjunctival administration of an appropriate anesthetic.
Administer 2–3 drops of an appropriate topical antiseptic agent into the conjunctival sac. The eyelids may be cleansed with swabs containing an appropriate topical antiseptic. A sterile eyelid speculum should be inserted. The patient should be instructed to look upward, and an antiseptic-soaked gauze-wrapped applicator should be applied to the injection site. After application of the antiseptic, wait 30–60 seconds to allow it to dry before injecting the ILUVIEN implant.
The outer surface of the container is not considered sterile. A non-sterile assistant should remove the container from the carton and inspect the container and cap for damage. Do not use if damaged. If the packaging is undamaged, the assistant should remove the cap without touching the inner surface.
Visually confirm through the viewing window of the filled applicator that the drug implant is present inside.
Remove the applicator from the container using sterile gloves, touching only the sterile surfaces of the applicator. Do not remove the protective needle cap until the ILUVIEN implant is ready for injection. Before injection, hold the applicator tip above the horizontal plane to ensure the implant is properly positioned within the applicator.
To minimize the amount of air injected with the implant, administration requires a two-step process. Before inserting the needle into the eye, press and advance the plunger to the first stop (to the wavy black marks adjacent to the plunger track). At the first stop, release the plunger, which will move to the "UP" position. Do not use the applicator if the plunger does not return to the "UP" position.
The optimal implant location is below the optic disc and posterior to the equator of the eye. Using a caliper, measure 4 millimeters in the inferior temporal direction from the limbus.
Carefully remove the protective needle cap and inspect the needle tip for bending.
Gently retract the conjunctiva so that the entry points into the conjunctiva and sclera are not in a straight line. Take care to avoid contact between the needle and the eyelid margins or eyelashes. Insert the needle into the eye. To deliver the implant, while the plunger is in the "UP" position, press and advance the plunger fully, then withdraw the needle. Caution: Before withdrawing the needle, ensure that the plunger has been fully depressed.
Remove the eyelid speculum and perform indirect ophthalmoscopy to confirm proper implant placement, adequate perfusion of the central retinal artery, and absence of complications. Scleral indentation may aid in visualizing the implant. The examination should include assessment of optic nerve head perfusion immediately after injection. At the ophthalmologist's discretion, intraocular pressure (IOP) may be measured directly after the procedure.

After the procedure, patients should be monitored for possible complications such as endophthalmitis, increased intraocular pressure, retinal detachment, vitreous hemorrhage or separation, and hypotony (occurring within 8 days of treatment). Slit-lamp biomicroscopy with tonometry should be performed between two and seven days after implant injection.
Thereafter, patients should be monitored at least quarterly for possible complications due to the prolonged release period of fluocinolone acetonide, which lasts approximately 36 months.