ILUVIEN 190 MICROGRAMS INTRAVITREAL IMPLANT IN APPLICATOR

Introduction

Package Leaflet: Information for the User

ILUVIEN 190 micrograms intravitreal implant in applicator

Fluocinolone, acetonide

Read all of this leaflet carefully before you are given this medicine because 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 experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is ILUVIEN and what is it used for
2. What you need to know before you are given ILUVIEN
3. How ILUVIEN is given
4. Possible side effects
5. Storing ILUVIEN
6. Contents of the pack and further information

1. What is ILUVIEN and what is it used for

Iluvien is a small tube that is inserted into the eye and releases very small amounts of the active ingredient, fluocinolone acetonide, for 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 have failed. Diabetic macular edema is a disease that affects some people with diabetes, causing damage to the light-sensitive layer in the back of the eye responsible for central vision, the macula. The active ingredient (the drug fluocinolone acetonide) helps to reduce inflammation and swelling that occurs in the macula. As a result, Iluvien may improve damaged vision or prevent it from getting worse.

Iluvien is used to prevent recurrences of inflammation in the back of the eye. This inflammation can cause floaters, which are black dots or lines scattered across what you see ("field of vision"), or can cause vision loss by damaging the part of the eye responsible for proper vision, called the "macula". Vision loss may not improve unless the inflammation is treated. Iluvien helps to reduce inflammation and swelling in the back of the eye. It may improve damaged vision or prevent it from getting worse. It may prevent future episodes of inflammation.

2. What you need to know before you are given ILUVIEN

Iluvien should not be given to you:

• If you are allergic to fluocinolone acetonide or any of the other ingredients of this medicine (listed in section 6).
• If you have an infection of any kind in the eye or in the area surrounding the eye.
• If you have glaucoma (high pressure inside the eye).

Warnings and precautions

• Before the injection of Iluvien, tell your doctor if:
• • You are taking anticoagulants
  • You have previously had a herpes simplex infection (a long-lasting ulcer in the eye).
• Iluvien is given as an injection into the eye. Occasionally, the injection can cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina. It is essential to identify and treat these conditions as soon as possible. Contact your doctor immediately if you experience increasing eye pain or discomfort, worsening redness of the eye, flashing lights, and a sudden increase in floaters, partially blocked vision, blurred vision, or decreased vision, increased sensitivity to light, or other visual disturbances after the injection.
• In some patients, the pressure in the eye may increase, with possible development of glaucoma. This is something you may not notice; consequently, your doctor will need to check it during your clinic visits.
• In most patients who have not yet undergone cataract surgery, a cloud may form in the eye's natural lens (a cataract) after treatment with Iluvien. If this happens, your vision will decrease, and you will likely need surgery to remove the cataract. Your doctor will help you decide when it is the right time for this surgery, but you should be aware that until you are ready for surgery, your vision may be as bad or worse than it was before receiving the Iluvien injection.
• Iluvien injection has not been studied in both eyes at the same time, and therefore, it is not recommended. Your doctor should not inject Iluvien into both eyes at the same time.
• There is a possibility that the Iluvien implant may move from the back to the front of the eye. There is a higher risk of this happening if you have had previous cataract surgery. A sign that the implant may have moved to the front of the eye could be distorted vision or other visual disturbances, inflammation of the eye surface (inflammation of the cornea), or you may notice a change in the appearance of your eye in the front. Inform your doctor immediately if you notice anything unusual that may suggest the implant has moved.
• In patients with inflammation in the back of the eye, the pressure in the eye may decrease, but it usually lasts only a few days after the injection. This is something you may not notice; therefore, your doctor will need to check it between 2 and 8 days after the injection and during your subsequent clinic visits.

Children and adolescents (under 18 years)

Iluvien has not been studied in children and adolescents. Therefore, its use in this population is not recommended.

Interaction of Iluvien with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

• Experience with the use of Iluvien in pregnant or breastfeeding women is limited; consequently, the possible 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before treatment with Iluvien.

Driving and using machines

After treatment with Iluvien, you may temporarily experience some blurred vision. If this happens, do not drive or use machines until this symptom disappears.

3. How ILUVIEN is given

The injection of Iluvien will be given by your ophthalmologist.

Iluvien is given as a single injection into the eye. Afterward, your doctor will regularly check your vision.

Before the injection, your doctor will use antibiotic eye drops and carefully clean your eye to prevent infections. Your doctor will also apply a local anesthetic to avoid any pain that the injection may cause.

Before and after the injection, your doctor may ask you to use antibiotic eye drops to prevent any possible infection in the eyes. Follow these instructions carefully.

If the effect of the implant wears off and your doctor recommends it, another implant can be injected into the eye. This only applies if you are given Iluvien for the treatment of diabetic macular edema.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Iluvien can cause side effects, although not everybody gets them.

With the administration of Iluvien, some side effects may occur, mainly in the eye. Occasionally, the injection can cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina. It is essential to identify and treat these conditions as soon as possible. Inform your doctor immediately if you experience increasing eye pain or discomfort, worsening redness of the eye, flashing lights, and a sudden increase in floaters, partially blocked vision, blurred vision, or decreased vision, increased sensitivity to light, or other visual disturbances after the injection. Other side effects may include an increase or decrease in eye pressure or a cloud in the eye's natural lens. An increase in eye pressure that damages the optic nerve (glaucoma) may be more likely if your intraocular pressure is above average before treatment. Your doctor will discuss the risks of this circumstance with you before treatment. In section 2 of this leaflet (Warnings and precautions), the symptoms you may experience and what you should do if you experience these symptoms are described.

The following side effects may occur with Iluvien:

Verycommon(may affect more than 1 in 10 people)

Increased eye pressure, cloud or cataract in the eye's natural lens, or eye surgery to correct cataract.

Common(may affect up to 1 in 10 people)

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 of the eye or inside the eye, small particles or spots in vision (floaters), sensation of seeing through steam or fog, decreased eye pressure that causes sudden pain and blurred vision, loss of your usual field of vision, eye pain or irritation, reduced vision, or eye surgery or procedure to relieve increased eye pressure or to remove the gel-like material that fills the back of the eye, increased proteins and cells in the front of the eye due to inflammation, sensation of a foreign body in the eye, or dry eye.

Uncommon(may affect up to 1 in 100 people)

Blockage of blood vessels in the back of the eye, growth of new blood vessels inside the eye, ulcer in the white of the eye, changes in the gel-like material that fills the back of the eye, a cloud in the bag that holds the eye's lens, redness of the eye, itching, or infection in the eye, thinning of the white outer layer of the eye, eye trauma from the injection of the medicine, unintentional movement of the implant through the white 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, inflammation of the eye surface (inflammation of the cornea), involuntary blinking, pain and discomfort in the eyes with sudden onset of intense pain associated with blurred vision, deposits on the outer layer of the eye, painful eye caused by a scratch on the eye surface, swelling of the eye.

The most common non-visual side effect reported as possibly caused by the drug or the injection procedure is headache.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing ILUVIEN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the inner packaging after EXP.
• Store below 30°C.
• Do not refrigerate or freeze.
• Do not open the packaging that contains the applicator until immediately before administration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Dispose of the applicator safely in a puncture-resistant container for biohazardous sharps.

6. Container Content and Additional Information

Composition of Iluvien

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

Product Appearance and Container Content

Iluvien consists of a small, light brown tube (approximately 3.5 mm x 0.37 mm), which is preloaded in an applicator system. The preloaded applicator is placed in a polycarbonate container and sealed with a removable cap. Each sealed container is delivered in a box that includes the package insert.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Alimera Sciences Europe Limited

77 Sir John Rogerson’s Quay

Dublin 2

Ireland

Manufacturer:

Millmount Healthcare Limited

Block-7, City North Business Campus

Stamullen

Co. Meath

K32 YD60

Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

BRILL PHARMA, S.L.

C/ Munner, 8,

08022 Barcelona (Spain)

93 417 09 11

This medicinal product is authorized in the following European Economic Area Member States under the invented name “Iluvien”:

Germany, Austria, Belgium, Denmark, Spain, Finland, France, Ireland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, Sweden, United Kingdom, and the Czech Republic.

Date of last revision of this package insert: 07/2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended exclusively for healthcare professionals:

THERAPEUTIC INDICATIONS

Iluvien is indicated for the treatment of:

• visual impairment associated with chronic diabetic macular edema, when the response to available therapies is considered insufficient.
• prevention of recurrence of non-infectious recurrent uveitis affecting the posterior segment of the eye.

CONTRAINDICATIONS

Intravitreal implantation with Iluvien is contraindicated in the presence of pre-existing glaucoma or active or suspected ocular or periocular infection, including most viral corneal and conjunctival diseases, such as herpes simplex epithelial keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and mycoses.

Iluvien is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients
• Infectious uveitis

ADMINISTRATION

EXCLUSIVELY FOR INTRAVITREAL USE.

Treatment with Iluvien is exclusively for intravitreal use and should be administered by an experienced ophthalmologist in the application of intravitreal injections.

The procedure for intravitreal injection should be performed under controlled aseptic conditions, including the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Before injection, adequate anesthesia and a broad-spectrum antimicrobial agent should be administered.

The procedure for injecting Iluvien is as follows:

1. An antibiotic may be administered in drops before the operation, at the discretion of the treating ophthalmologist.
2. Immediately before injection, administer a drop of topical anesthesia over the injection site (recommended in the inferotemporal quadrant), followed by either an applicator with a cotton tip soaked in anesthetic or subconjunctival administration of an appropriate anesthetic.
3. Administer 2-3 drops of an appropriate topical antimicrobial agent in the lower fornix. The eyelids may be rubbed with an applicator with a cotton tip soaked in the appropriate antimicrobial agent. Place a sterile eyelid speculum. Have the patient look up, and apply an applicator with a cotton tip soaked in the antimicrobial agent to the injection site. Allow the topical antimicrobial application to dry for 30-60 seconds before injecting Iluvien.
4. The exterior of the container holding the applicator should not be considered sterile. A non-sterile assistant should remove the container with the applicator from the box and examine the container and its cap for damage. If they are damaged, do not use the unit. If they are acceptable, the assistant should remove the cap without touching the inner surface.
5. Visually inspect the preloaded applicator's viewing window to verify that a pharmaceutical implant is inside.
6. Remove the applicator from the container with sterile gloves on, touching only the applicator and the sterile surface.

The protective cap of the needle should not be removed until Iluvien is ready to be injected.

Before injection, the tip of the applicator should be kept above the horizontal plane to ensure that the implant is properly placed in the applicator.

1. To reduce the amount of air administered with the implant, the administration procedure requires two steps. Before inserting the needle into the eye, push the button down and slide it to the first stop (at the curved black marks along the button path). At the first stop, release the button, and it will move to the UP (up) position. If the button does not move to the UP (up) position, do not proceed with this unit.
2. The ideal location of the implant is inferior to the optic disc and posterior to the equator of the eye. Measure 4 millimeters in the inferotemporal direction from the limbus, with the aid of a caliper.
3. Remove the protective cap of the needle with care and inspect the tip to ensure it is not bent.
4. Gently displace the conjunctiva so that, when the needle is withdrawn, the entry points of the needle in the conjunctiva and sclera are not aligned. Precautions should be taken to 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 UP (up) position, advance the button by sliding it forward to the end of its path and withdraw the needle. Note: Ensure the button reaches the end of its path before withdrawing the needle.
5. Remove the eyelid speculum and perform an indirect ophthalmoscopy to verify the location of the implant, adequate perfusion of the central retinal artery, and the absence of any other complications.

Scleral depression may improve visualization of the implant. The examination should include a check of the optic nerve head perfusion immediately after injection. At the discretion of the ophthalmologist, an immediate measurement of intraocular pressure (IOP) may be performed.

After the procedure, patients should be monitored for possible complications such as endophthalmitis, increased intraocular pressure, retinal detachments, and vitreous or retinal hemorrhages and hypotony (observed up to 8 days after treatment). A biomicroscopy with tonometry should be performed within 2 to 7 days after injection of the implant.

Subsequently, it is recommended to monitor patients at least quarterly to detect possible complications, given the prolonged duration of fluocinolone acetonide release, approximately 36 months.