Iluvien

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

ILUVIEN, 190 micrograms, intravitreal implant in an applicator

(Fluocinolone acetonide)

Read the leaflet carefully before receiving the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What ILUVIEN is and what it is used for
• 2. Important information before receiving ILUVIEN
• 3. How ILUVIEN is administered
• 4. Possible side effects
• 5. How to store ILUVIEN
• 6. Contents of the packaging and other information

1. WHAT ILUVIEN IS AND WHAT IT IS USED FOR

ILUVIEN is a small 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 edema, when other available treatments are not effective. Diabetic macular edema is a condition that occurs in some people with diabetes and causes damage to the sensitive layer at the back of the eye, responsible for central vision - the macula.
The active substance (fluocinolone acetonide) helps reduce inflammation and swelling that occurs in the macula in this condition. Therefore, ILUVIEN may help treat vision disturbances or prevent their worsening.
ILUVIEN is used to prevent relapses of inflammation in the back of the eye. Inflammation can cause the appearance of floaters in the vitreous, which take the form of black spots or blurred lines moving in front of the patient's vision, or may cause vision loss by destroying the part of the eye responsible for good vision, called the "macula". Vision loss can be permanent if inflammation is not treated. ILUVIEN helps reduce inflammation and the swelling it causes, which can occur in the back of the eye. It may support improved vision in the patient or help prevent its worsening. It may also prevent the occurrence of inflammatory conditions in the future.

2. IMPORTANT INFORMATION BEFORE RECEIVING ILUVIEN

When not to use ILUVIEN:

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

Warnings and precautions

• Before starting treatment with ILUVIEN, the patient should discuss it with their doctor if:
• Blood thinning medicines are being used;
• There has been a history of herpes simplex virus infection in the eye (a long-standing corneal ulcer).
• ILUVIEN is administered by injection into the eye. Sometimes, the injection can cause infection inside the eye, pain, and redness of the eye, or detachment or tearing of the retina. It is essential to diagnose and treat them as soon as possible. The patient should immediately contact their doctor if they experience severe pain or discomfort in the eye, increasing redness of the eye, flashes, and sudden increase in floaters in the vitreous, partial vision loss, blurred or impaired vision, increased sensitivity to light, or other vision disturbances after injection.
• In some patients, eye pressure may increase, with possible development of glaucoma. This may not be noticeable, so the patient must be monitored by their doctor during visits to the clinic.
• In most patients who have not had cataract surgery, cataract (clouding of the eye's natural lens) may occur due to treatment with ILUVIEN. If this happens, vision will deteriorate, and cataract surgery will likely be necessary. The doctor will help decide when it is the best time for this surgery, but the patient should be aware that until the surgery, vision may be poor or worse than it was before the ILUVIEN injection.
• It has not been studied whether ILUVIEN can be injected into both eyes at the same time, and it is not recommended. The doctor should not inject ILUVIEN into both eyes at the same time.
• There is a risk of the ILUVIEN implant moving from the back to the front of the eye. The increased risk occurs in people who have had cataract surgery. A symptom of the implant moving to the front of the eye may be distorted vision or other vision 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 movement, the doctor should be informed immediately.
• In patients with inflammation in the back of the eye, intraocular pressure may decrease, which usually lasts for several days after injection. The patient may not notice this, so they must be monitored by their doctor for 2 to 8 days and during subsequent clinic visits.

Children and adolescents (under 18 years of age)

ILUVIEN has not been studied in children and adolescents, and therefore, its use is not recommended.

ILUVIEN and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

• There is limited data on the use of ILUVIEN in pregnant or breastfeeding women, so the risk is unknown.
• There is no data on the effect on fertility. Since ILUVIEN is injected directly into the eye, the impact on fertility in men or women is unlikely.
• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using ILUVIEN.

Driving and using machines

After using ILUVIEN, temporary blurred vision may occur. If this happens, the patient should not drive or operate machinery until the disturbance has resolved.

3. HOW ILUVIEN IS ADMINISTERED

The injection of ILUVIEN will be performed by an ophthalmologist.
ILUVIEN is administered in a single injection into the eye. Then, the doctor will regularly monitor the patient.
Before the injection, the doctor will apply antibiotic eye drops and thoroughly rinse the eye to prevent infection. The doctor will also apply a local anesthetic to prevent pain that may be caused by the injection.
Before and after the injection, the doctor may ask the patient to use antibiotic eye drops to prevent any possible eye infection.
The patient should strictly follow these instructions.
If the implant stops working and it is recommended by the doctor, another implant may be injected into the eye. This only applies to patients being treated with ILUVIEN for diabetic macular edema.
In case of any further doubts about using this medicine, the patient should consult their doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ILUVIEN can cause side effects, although not everybody gets them.
When using ILUVIEN, certain side effects may occur, most of which are related to the eye. Sometimes, the injection can cause infection inside the eye, pain, or redness of the eye, or detachment or tearing of the retina. It is essential to diagnose and treat them as soon as possible. The patient should immediately tell their doctor if they experience severe pain or discomfort in the eye, increasing redness of the eye, flashes, and sudden increase in floaters in the vitreous, partial vision loss, blurred or impaired vision, and increased sensitivity to light after injection. Other side effects include increased or decreased eye pressure and clouding of the eye's natural lens. Increased eye pressure that damages the optic nerve (glaucoma) is more likely if the eye pressure is higher than average before treatment. The doctor will discuss the risks associated with this before treatment. The symptoms that may occur and what to do if they occur are described in section 2 of this leaflet (Warnings and precautions).
After the injection of ILUVIEN, the following side effects may occur:
Very common(occurring in more than 1 in 10 patients)
Increased eye pressure, clouding of the eye's natural lens (cataract), or the need for cataract surgery.
Common(occurring in 1 to 10 in 100 patients)
Increased eye pressure that damages the optic nerve (glaucoma), detachment of the light-sensitive layer in 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 field of vision (vitreous floaters), the feeling of looking through fog or haze, decreased eye pressure causing sudden pain and blurred vision, loss of normal field of vision, eye pain or irritation, impaired vision or the need for eye surgery or a procedure to reduce increased pressure or remove the gel-like material that fills the back of the eye, increased amount of proteins and cells in the front part of the eye due to inflammation, feeling of a foreign body in the eye, dry eye.
Uncommon(occurring in less than 1 in 100 patients)
Closure of blood vessels in the back of the eye, growth of new blood vessels inside the eye, ulcer in the white part of the eye, changes in the gel-like substance that fills the back of the eye, clouding of the lens capsule, redness of the eye, itching or eye infection, thinning of the white outer part of the eye, eye injury due to the injection, unplanned movement of the implant through the white part of the eye, and (or) other complications due to 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 severe pain, sometimes accompanied by blurred vision, deposits on the outer layer of the eye, painful eye condition caused by itching of the eye surface, eye swelling.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. HOW TO STORE ILUVIEN

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or the immediate packaging after "Expiry date".
• Store at a temperature below 30°C.
• Do not store in the refrigerator or freeze.
• Do not open the foil-covered tray until immediately before use.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use.
• The used applicator should be disposed of safely in a container for sharp objects that pose a biological hazard.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What ILUVIEN contains

• The active substance is fluocinolone acetonide.
• Each intravitreal implant contains 190 micrograms of fluocinolone acetonide.
• Other ingredients are: Excipients: polyvinyl alcohol. Excipients in the implant: polyimide tube, silicone coating, polyvinyl alcohol.

What ILUVIEN looks like and what the pack contains

ILUVIEN consists of a small, 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 in a carton, which contains the leaflet.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Date of last revision of the leaflet:08/2023

This medicinal product is authorized in the Member States of the European Economic Area under the trade 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
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Information intended for healthcare professionals only:

INDICATIONS

ILUVIEN is intended for:

• treatment of vision disturbances associated with chronic diabetic macular edema, not responding sufficiently to other available therapies
• preventive treatment of relapses in the course of recurrent non-infectious uveitis affecting the posterior segment of the eye

CONTRAINDICATIONS

ILUVIEN intravitreal implant is contraindicated in the presence of glaucoma or active or suspected eye or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial keratitis (dendritic keratitis) caused by Herpes simplex, chickenpox, shingles, Mycobacteriuminfections, and fungal diseases.
ILUVIEN is contraindicated in patients with:

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

DOSAGE AND ADMINISTRATION

INTRAVITREAL ADMINISTRATION ONLY.
ILUVIEN is intended for intravitreal administration only and should be administered by an ophthalmologist experienced in performing intravitreal injections. The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include sterile gloves, a sterile speculum, and a sterile eyelid speculum (or equivalent). Before injection, proper anesthesia and a broad-spectrum antimicrobial agent should be used.
The ILUVIEN implant procedure should be performed as follows:

• 1. Antibiotic drops may be administered before the procedure at the discretion of the ophthalmologist.
• 2. Immediately before the procedure, local anesthesia should be applied at the injection site (recommended: lower temporal quadrant) in the form of one drop, followed by the use of a cotton swab applicator soaked in anesthetic or subconjunctival administration of appropriate anesthesia.
• 3. 2-3 drops of a proper antimicrobial agent should be administered to the conjunctival sac. The eyelids may be wiped with applicators with a tip soaked in a proper antimicrobial agent. A sterile eyelid speculum should be applied. The patient should be instructed to look up, and an applicator with a cotton swab tip soaked in a proper antimicrobial agent should be applied to the injection site. Before injecting the ILUVIEN implant, wait 30-60 seconds for the antimicrobial agent to dry.
• 4. The outside of the container should notbe considered sterile. A non-sterile assistant should remove the container from the carton and check if the container and cap are damaged. Do not use if damaged. If the packaging is not damaged, the assistant should remove the cap without touchingthe inner surface.
• 5. Visually verify through the applicator's fill window that the implant with the drug is inside.
• 6. Remove the applicator from the container using sterile gloves, touching only the sterilesurface and applicator. Do not remove the protective cap from the needle 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 in the applicator.
• 7. To minimize the amount of air injected with the implant, the administration requires a two-stage process. Before inserting the needle into the eye, press the button and slide it to the first stop (to the wavy black marks next to the sliding button). At the first stop, release the button, and it will move to the "UP" position. Do not use the applicator if the button does not move to the "UP" position.
• 8. The optimal position of the implant is below the optic disc and behind the equator of the eye. Using a caliper, measure 4 millimeters down temporally from the limbus.
• 9. Carefully remove the protective cap from the needle and check if the needle tip is not bent.

• 10. Gently retract the conjunctiva so that the injection sites of the needle into the conjunctiva and sclera are not in the same line. Be careful to avoid contact between the needle and the edge of the eyelids and eyelashes. Insert the needle into the eye. To inject the implant, while the button is in the "UP" position, press and slide the button to the end and remove the needle. Note: Before removing the needle, ensure the button has been pressed to the end.
• 11. Remove the eyelid speculum and perform indirect ophthalmoscopy to verify the implant's position, proper perfusion of the central retinal artery, and the absence of any other complications. Scleral depression may help visualize the implant. The examination should include checking the perfusion of the optic nerve head immediately after injection. According to the ophthalmologist's judgment, direct intraocular pressure (IOP) measurement may be performed.

After the procedure, patients should be monitored for possible complications, such as endophthalmitis, increased intraocular pressure, retinal detachment, and vitreous hemorrhage or its separation, as well as hypotony (occurring up to 8 days after treatment). Two to seven days after the injection, biomicroscopy with tonometry should be performed.
Then, it is recommended that patients be monitored at least once a quarter for possible complications, considering the prolonged period of fluocinolone acetonide release, which is approximately 36 months.