ILUVIEN 190 MICROGRAMS Implant

Зміст інструкції

1. ILUVIEN 190 micrograms intraocular implant in applicator
   1. WHAT IS ILUVIEN AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE RECEIVING ILUVIEN
   3. METHOD OF ADMINISTRATION OF ILUVIEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ILUVIEN
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

ILUVIEN 190 micrograms intraocular implant in applicator

(fluocinolone acetonide)

Read this leaflet carefully before you are given this medicine as it contains
important information for you.

• 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, even 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 IS ILUVIEN AND WHAT IS IT USED FOR

ILUVIEN is a thin tube that is inserted into the eye and releases very small amounts of the active ingredient
it contains, fluocinolone acetonide, for a maximum period of 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 that affects some
people with diabetes by damaging the light-sensitive layer at the back of the eye responsible for
central vision, the macula. The active ingredient (the drug fluocinolone acetonide) helps to reduce
the inflammation and swelling that occur in the macula due to this condition. ILUVIEN can therefore
help to improve damaged vision or prevent it from worsening.

2. WHAT YOU NEED TO KNOW BEFORE RECEIVING ILUVIEN

Do not use ILUVIEN:

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

Warnings and precautions

• Before the injection of ILUVIEN, inform your doctor if:
• you are taking anticoagulant drugs;
• you have previously had an eye infection with herpes simplex (an eye ulcer that lasted a long time).
• ILUVIEN is administered by injection inside the eye. On some occasions, the injection may cause eye infection, pain or redness, or retinal detachment or tearing. It is important that these effects are identified and treated as soon 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 or a sudden increase in floaters, partial obstruction of vision, decreased vision, or increased sensitivity to light.
• In some patients, it is possible to increase the pressure in the eyes with the potential development of glaucoma. Because you may not notice this event, your doctor will subject you to regular check-up visits.
• In the majority of patients who have not yet undergone cataract surgery, during treatment with ILUVIEN, a loss of transparency (cataract) of the natural lens of the eye (the crystalline lens) may occur.

If this happens, there will be a decrease in vision and surgery to remove the cataract will probably be necessary.
The doctor will help you determine the most suitable time to have the surgery. However, keep in mind
that until the time of the operation your vision may be as it was before the ILUVIEN injection
or worse.

• Because it has not been studied, simultaneous injection of ILUVIEN into both eyes is not recommended. The doctor should not inject ILUVIEN simultaneously into both eyes.
• There is a potential risk that the ILUVIEN implant may move from the back to the front of the eye. This risk is greater if you have previously undergone cataract surgery. One of the signs that indicates the displacement of the implant towards the front of the eye could be the presence of distorted vision or other visual disturbance, or you may notice a change in the appearance of the front of the eye. Inform your doctor if you notice anything unusual that might lead you to suspect that 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
Tell your doctor if you are taking or have recently taken any other medicines, including those on prescription
medical.

Pregnancy, breastfeeding and fertility

• Since no data are available on the use of ILUVIEN in pregnant women or during breastfeeding, the potential risks are unknown.
• No data are available on fertility. However, since ILUVIEN is inserted directly into the eye, it is unlikely to have effects on male or female fertility.
• If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before treatment with ILUVIEN.

Driving and operating machinery
Temporary blurred vision is possible after treatment with ILUVIEN. If this happens, do not drive
or operate machinery until your vision returns.

3. METHOD OF ADMINISTRATION OF ILUVIEN

The injection of ILUVIEN will be administered by your ophthalmologist.
ILUVIEN is administered by a single injection inside your eyes. Subsequently, the doctor
will subject you to periodic eye examinations.
Before the injection, the doctor will apply an antibiotic eye drop and carefully clean the eye to prevent
the onset of infections. He/she will also administer a local anesthetic to prevent any pain that the injection
may cause.
The doctor may ask you to use an antibiotic eye drop before and after the injection to prevent possible eye
infections. Follow their instructions carefully.
If the effect of the implant fades and your doctor recommends it, another implant may be injected.
If you have any doubts about the use of this medicine, please consult your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ILUVIEN can cause side effects, although not everybody gets them.
Administration of ILUVIEN may be associated with some side effects, most of which affect
the eye. In some cases, the injection may cause infection inside the eyes, eye pain or redness, or retinal detachment or
tear. It is important that these effects are identified and treated as soon as possible. Immediately inform your doctor if
you develop any of the following symptoms after the injection: increased eye pain or discomfort, worsening eye redness,
flashes of light or a sudden increase in floaters, partial blockage of the visual field, decreased vision, or increased
sensitivity to light. Other side effects may include increased eye pressure or clouding of the lens. Increased pressure
inside the eye, potentially damaging the optic nerve (glaucoma), may be more likely if the intraocular pressure was above
average before treatment. Your doctor will discuss these risks with you before 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 side effects have been observed in clinical studies conducted with ILUVIEN.

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

Common(affects 1 to 10 in 100 people)
Bleeding in the sclera or white part (the outermost layer) of the eye or inside the eye, small
particles or spots in the visual field (floaters), increased pressure in the eye that damages the optic
nerve (glaucoma), eye pain or irritation, decreased vision or eye surgery or procedure to
restore eye pressure or remove the gelatinous material that fills 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,
ulcer on the sclera of the eye, changes in the gelatinous material that fills the back of the eye,
clouding of the sac containing the lens, eye redness, itching or eye infection,
thinning of the sclera of the eye, eye trauma caused by the injection of the medicine, unexpected
movement of the implant through the sclera and/or other injection-related complications, displacement of the ILUVIEN
implant from the back to the front of the eye.
The most common side effect not related to vision considered possibly associated with the medicine or
the injection is headache.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/it/responsabili..
By reporting side effects 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 on the inner wrapper after Scad.
• Store at a temperature below 30°C.
• Do not refrigerate or freeze.
• Open the sealed pack only just before application.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ILUVIEN contains

• The active ingredient 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 with silicone adhesive at one end and with polyvinyl alcohol at the other end.

Description of ILUVIEN and contents of the pack
ILUVIEN is presented as a thin, light brown-colored tube (approximately 3.5 mm x 0.37 mm) preloaded in an
applicator. The preloaded applicator is contained in a polycarbonate case sealed with a film. Each

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ALIMERA SCIENCES EUROPE LIMITED
77 SIR JOHN ROGERSON'S QUAY, 2 DUBLIN
Marketing Authorisation Distributor:
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 Member States of the European Economic Area with the designation
“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 visual impairment associated with chronic diabetic macular edema
that is insufficiently responsive to other available therapies.

CONTRAINDICATIONS
The intravitreal implantation of ILUVIEN is contraindicated in the presence of glaucoma or active or suspected
ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including 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
FOR 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 blepharostat (or equivalent). Adequate anesthesia and a broad-spectrum
microbicide must be administered prior to the injection.
The injection procedure for ILUVIEN is described below.

• 1. Antibiotic eye drops may be administered prior to the injection at the discretion of the treating ophthalmologist.
• 2. Immediately before the injection, apply a topical anesthetic drop to the injection site (the inferotemporal quadrant is recommended), followed by application with a cotton swab moistened with the anesthetic or subconjunctival administration of an adequate anesthetic.

• 3. Administer 2-3 drops of an adequate topical antiseptic to the inferior fornix. The eyelids may be rubbed with the tip of cotton swabs moistened with an adequate topical antiseptic. Position a sterile blepharostat. While the subject looks upwards, moisten the injection site using a cotton swab moistened with an adequate antiseptic and wait 30-60 seconds for the topical antiseptic to dry before proceeding with the ILUVIEN injection.
• 4. The exterior of the pack is notsterile. The pack must be removed from the packaging by an assistant (non-sterile), who will examine the pack and the film to verify that they are not damaged. If damaged, the unit must not be used. If acceptable, the assistant will lift the film without touching the inner surface.
• 5. Visually inspect through the applicator’s observation window that an implant is actually present inside.
• 6. Remove the applicator from the pack using sterile gloves and touching only the sterile surface and the applicator. The needle protective cap must only be removed when the ILUVIEN injection is ready. Before proceeding with the injection, the applicator tip must be held above the horizontal plane to ensure correct positioning of the implant inside the applicator.
• 7. To reduce the amount of air administered with the implant, the administration procedure must be performed in two steps. Before inserting the needle into the eye, press the button moving it to the first notch (corresponding to the curved black markings along the track), then release the button which will return to the raised position. If the button does not return to the raised position, do not use this unit.
• 8. Optimal implant positioning is inferior to the optic disc and posterior to the equator of the eye. Using a caliper, measure 4 millimeters from the limbus in the inferotemporal quadrant.
• 9. Carefully remove the protective cap from the needle and check that the tip is not bent.
• 10. Gently displace the conjunctiva so that after the needle is removed, the conjunctival and scleral entry points do not coincide. 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 to the stop and withdraw the needle. Note: ensure that the button is fully advanced before removing the needle.
• 11. Remove the blepharostat and perform indirect ophthalmoscopy to verify the implant positioning, adequate perfusion of the central retinal artery and the absence of any other complications. Gentle pressure on the sclera will allow better visualization of the implant. The examination should include a check of the perfusion of the optic nerve head immediately after the injection. Immediate IOP measurement may be performed at the discretion of the ophthalmologist.

Following the procedure, patients must be monitored for potential complications such as endophthalmitis,
increased intraocular pressure, retinal detachment, and vitreous hemorrhage or detachment. Biomicroscopy with tonometry should be performed 2-7 days
after implant insertion.
Subsequently, it is recommended to monitor patients at least every 3 months for potential complications
due to the prolonged release (approximately 36 months) of fluocinolone acetonide.