Iluvien

PACKAGE LEAFLET: INFORMATION FOR THE USER

ILUVIEN 190 micrograms intravitreal implant in applicator

(fluocinolone acetonide)
Please read this leaflet carefully before this medicine is administered to you because it contains
important information for you.

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

Contents of this leaflet

1. What ILUVIEN is and what it is used for
2. What you need to know before you receive ILUVIEN
3. How ILUVIEN is administered
4. Possible side effects
5. How to store ILUVIEN
6. Contents of the pack and other information

1. WHAT ILUVIEN IS AND WHAT IT IS USED FOR

ILUVIEN is a small tube inserted into the eye that releases tiny amounts of its 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 for the treatment of vision loss associated with diabetic macular edema when other available treatments have not proven effective. Diabetic macular edema is a condition affecting some people with diabetes, damaging the light-sensitive layer at the back of the eye responsible for central vision, known as the macula. The active substance (the drug fluocinolone acetonide) helps reduce the inflammation and swelling occurring in the macula due to this condition. ILUVIEN may therefore help improve impaired vision or prevent it from worsening.

2. WHAT YOU SHOULD KNOW BEFORE RECEIVING ILUVIEN

Do not use ILUVIEN:

• if you are allergic to fluocinolone acetonide or to any of the other ingredients of this medicine (listed in section 6);
• if you have any type of ocular or periocular infection;
• if you have glaucoma (increased eye pressure).

Warnings and precautions

• Before receiving an ILUVIEN injection, inform your doctor if:
• you are taking anticoagulant medicines;
• you have previously had an eye infection caused by herpes simplex (a long-lasting eye ulcer).
• ILUVIEN is administered by injection into the eye. In some cases, the injection may cause infection, eye pain, or redness, or may lead to retinal detachment or tear. It is important that these effects are identified and treated as early as possible. Immediately inform your doctor if, after the injection, you develop any of the following symptoms: increased eye pain or discomfort, worsening eye redness, flashes of light, sudden increase in floaters, partial vision obstruction, vision loss, or increased sensitivity to light.
• In some patients, eye pressure may increase, potentially leading to glaucoma. Since you may not notice this, your doctor will schedule regular follow-up examinations.
• In most patients who have not yet undergone cataract surgery, loss of clarity (cataract) of the eye's natural lens (the crystalline lens) may occur during treatment with ILUVIEN.

If this occurs, vision may decline and cataract removal surgery may become necessary. Your doctor will help determine the most appropriate time for surgery. However, please note that until surgery is performed, your vision may remain as it was before the ILUVIEN injection or may worsen.

• Simultaneous injection of ILUVIEN into both eyes has not been studied and is therefore not recommended. Your doctor must not inject ILUVIEN into both eyes at the same time.
• There is a potential risk that the ILUVIEN implant may move from the back to the front part of the eye. This risk is higher if you have previously undergone cataract surgery. Signs indicating that the implant has moved to the front of the eye may include distorted vision or other visual disturbances, or you may notice a change in the appearance of the front part of the eye. Inform your doctor immediately if you notice anything unusual that may suggest the implant has moved.

Children and adolescents (under 18 years of age)
The use of ILUVIEN in children and adolescents has not been studied and is therefore not recommended.
Other medicines and ILUVIEN
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Pregnancy, breastfeeding and fertility

• Because there are no data on the use of ILUVIEN in pregnant or breastfeeding women, potential risks are unknown.
• There are no available data on fertility. However, since ILUVIEN is administered directly into the eye, it is unlikely to affect male or female fertility.
• If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before starting treatment with ILUVIEN.

Driving and using machines
After treatment with ILUVIEN, temporary blurred vision may occur. If this happens, do not drive or operate machinery until your vision has returned to normal.

3. METHOD OF ADMINISTRATION OF ILUVIEN

The injection of ILUVIEN will be administered to you by your ophthalmologist.
ILUVIEN is administered via a single injection into your eye. Afterwards, your doctor will perform regular vision check-ups.
Prior to the injection, your doctor will apply an antibiotic eye drop and carefully clean your eye to prevent the occurrence of infections. Your doctor will also administer a local anesthetic to prevent any pain that the injection may cause.
Your doctor may instruct you to use antibiotic eye drops before and after the injection to prevent possible eye infections. Follow their instructions carefully.
If the effect of the implant wears off and your doctor recommends it, another implant may be injected.
If you have any doubts about the use of this medicine, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ILUVIEN can cause adverse reactions, although not everyone experiences them.
Administration of ILUVIEN may lead to certain adverse reactions, most of which are related to the eye. In some cases, the injection may cause an infection inside the eye, eye pain or redness, or detachment or tear of the retina. It is important that these effects are identified and treated as early as possible. Immediately inform your doctor if, after the injection, you develop any of the following symptoms: increased eye pain or discomfort, worsening of eye redness, flashes of light or sudden increase in floaters, partial obstruction of the visual field, decreased vision, or increased sensitivity to light. Other adverse reactions may include increased eye pressure or clouding of the lens (cataract). An increase in intraocular pressure leading to damage of the optic nerve (glaucoma) may be more likely if intraocular pressure was above average before treatment. Your doctor will discuss these risks with you prior to treatment. The symptoms you may experience and what you should do if they occur are described in section 2 of this leaflet (Warnings and precautions).

The following adverse reactions have been observed in clinical studies with ILUVIEN.

Very common (affects more than 1 in 10 people)
Increased eye pressure, clouding of the lens (cataract), or need for ocular surgery to correct cataract.

Common (affects 1 to 10 in 100 people)
Bleeding of the sclera or the white part (the outermost membrane) of the eye or inside the eye, small particles or spots in the visual field (floaters), increased eye pressure causing damage to the optic nerve (glaucoma), eye pain or irritation, decreased vision, or need for eye surgery or procedures to restore eye pressure or to remove the gel-like substance filling the back of the eye.

Uncommon (affects less than 1 in 100 people)
Blockage of blood vessels in the back of the eye, growth of new blood vessels inside the eye, scleral ulcer, changes in the gel-like substance filling the back of the eye, clouding of the lens capsule, eye redness, itching or eye infection, thinning of the sclera, eye injury caused by the injection, unintended movement of the implant through the sclera and/or other complications due to injection, displacement of the ILUVIEN implant from the back to the front of the eye.

The most common non-ocular adverse reaction considered possibly related to the medicine or the injection is headache.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ILUVIEN

• Keep this medicine out of the reach and sight of children.
• Do not use this medicine after the expiry date stated on the carton and inner packaging following Exp.
• Store below 30°C.
• Do not refrigerate or freeze.
• Open the sealed carton only immediately before application.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ILUVIEN contains

• The active substance is fluocinolone acetonide.
• Each intravitreal implant contains 190 micrograms of fluocinolone acetonide.
• The other ingredient is polyvinyl alcohol.
• The implant is a thin tube made of polyimide, sealed at one end with silicone adhesive and at the other end with polyvinyl alcohol.

Description of the appearance of ILUVIEN and contents of the pack
ILUVIEN is a thin, light brown tube (approximately 3.5 mm x 0.37 mm), preloaded into an applicator. The preloaded applicator is contained in a sealed polycarbonate cartridge with a foil lid. Each cartridge is supplied in a package that includes the patient leaflet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ALIMERA SCIENCES EUROPE LIMITED
77 SIR JOHN ROGERSON'S QUAY, 2 DUBLIN
Republic of Ireland

Selling Agent:
S.I.F.I. S.p.A.
Via Ercole Patti, 36
95025 Aci S. Antonio (CT)
Italy

Manufacturer:
AndersonBrecon (UK) Limited
Wye Valley Business Park Hay-on-Wye
Hereford HR3 5PG, United Kingdom

This medicinal product is authorised in the European Economic Area Member States under the name “Iluvien”:
Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, United Kingdom, Czech Republic, Spain, Sweden.
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The following information is intended for healthcare professionals only.

THERAPEUTIC INDICATIONS
ILUVIEN is indicated for the treatment of vision impairment associated with chronic diabetic macular edema that is insufficiently responsive to available alternative therapies.

CONTRAINDICATIONS
The ILUVIEN intravitreal implant is contraindicated in the presence of glaucoma or active or suspected pre-existing ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, such as active herpes simplex epithelial keratitis (dendritic keratitis), vaccinia virus, varicella, mycobacterial infections, and fungal diseases.
ILUVIEN is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

METHOD OF ADMINISTRATION
INTRAVITREAL USE ONLY.
Treatment with ILUVIEN is for intravitreal use only and must be administered by an ophthalmologist experienced in intravitreal injections. The intravitreal injection procedure must be performed under controlled aseptic conditions, involving the use of sterile gloves, gown, and eyelid speculum (or equivalent). Prior to injection, appropriate anaesthesia and a broad-spectrum microbicide should be administered.

The ILUVIEN injection procedure is described below.

1. Prior to injection, antibiotic drops may be administered at the discretion of the treating ophthalmologist.
2. Immediately before injection, apply a drop of topical anaesthetic at the injection site (inferotemporal quadrant is recommended), followed by application using a cotton-tipped applicator soaked in anaesthetic or by subconjunctival administration of an appropriate anaesthetic.
3. Administer 2–3 drops of an appropriate topical antiseptic into the inferior fornix. The eyelids may be swabbed with a cotton-tipped applicator soaked in an appropriate topical antiseptic. Insert a sterile eyelid speculum. While the patient looks upward, moisten the injection site using a cotton-tipped applicator soaked in an appropriate antiseptic, and wait 30–60 seconds for the topical antiseptic to dry before proceeding with ILUVIEN injection.
4. The outer surface of the cartridge is not sterile. The cartridge must be removed from its package by an assistant (non-sterile), who will inspect the cartridge and foil seal for damage. If damaged, do not use the unit. If acceptable, the assistant will lift the foil seal without touching the inner surface.
5. Visually inspect through the viewing window of the preloaded applicator to confirm the presence of an implant inside.
6. Remove the applicator from the cartridge using sterile gloves and touching only the sterile surfaces and the applicator. The needle protective cap must be removed only when ready to administer the ILUVIEN injection. Prior to injection, hold the tip of the applicator above horizontal level to ensure correct positioning of the implant within the applicator.
7. To reduce the amount of air administered with the implant, the administration procedure should be performed in two steps. Before inserting the needle into the eye, press the button forward to the first detent (at the level of the curved black marks along the track), then release the button so it returns to the raised position. If the button does not return to the raised position, do not use this unit.
8. The optimal placement of the implant is below the optic disc and posterior to the equator of the eye. Using a caliper, measure 4 millimetres from the limbus in the inferotemporal quadrant.
9. Carefully remove the needle protective cap and check that the tip is not bent.
10. Gently displace the conjunctiva so that the conjunctival and scleral entry sites do not align after needle withdrawal. Avoid contact between the needle and the eyelid margin or eyelashes. Insert the needle into the eye. To release the implant, with the button in the raised position, slide it forward fully until it stops, then withdraw the needle. Note: ensure the button has reached the end stop before withdrawing the needle.
11. Remove the eyelid speculum and perform indirect ophthalmoscopy to verify correct implant placement, adequate perfusion of the central retinal artery, and absence of other complications. Apply gentle pressure on the sclera to better visualize the implant. The examination must include assessment of optic nerve head perfusion immediately after injection. Immediate measurement of intraocular pressure (IOP) may be performed at the ophthalmologist’s discretion.

Following the procedure, patients must be monitored for potential complications such as endophthalmitis, increased intraocular pressure, retinal detachment, and vitreous haemorrhage or detachment. Biomicroscopy with tonometry should be performed 2–7 days after implant insertion.
Thereafter, patients should be monitored at least every 3 months for potential complications related to the prolonged duration (approximately 36 months) of fluocinolone acetonide release.