Package Insert: Information for the User

ILUVIEN 190 micrograms intravitreal implant in applicator

Fluocinolone acetonide

Read this package insert carefully before this medicine is administered to you, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

1. What ILUVIEN is and for what it is used

2. What you need to know before ILUVIEN is administered to you

3. How ILUVIEN is administered

4. Possible adverse effects

5. Storage of ILUVIEN

6. Contents of the package and additional informationl

ILUVIEN is a small tube that is inserted into the eye and releases very small amounts of the active ingredient, fluocinolone acetonide, for a maximum of 3 years. Fluocinolone acetonide belongs to a group of medications 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, and causes damage to the light-sensitive layer in the back of the eye responsible for central vision, the macula. The active ingredient (the medication fluocinolone acetonide) helps to reduce inflammation and swelling that occur in the macula. As a result, ILUVIEN may improve damaged vision, or prevent it from worsening.

ILUVIEN is used to prevent recurrences of inflammation in the back of the eye. This inflammation may cause floaters, which are black spots or lines scattered throughout what is seen ("field of vision"), or may cause vision loss by damaging the part of the eye responsible for correct 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 worsening. It may stop future episodes of inflammation.

Do not administer Iluvien:

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

Warnings and precautions

• Before the injection of Iluvien, inform your doctor if:
• • You are taking anticoagulants.
  • You have previously had a herpes simplex infection (a prolonged eye ulcer).
• Iluvien is administered as an injection inside the eye. Occasionally, the injection may cause an infection inside the eye, 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 eye redness, intermittent lights, sudden increase in floating shapes, partial vision blockage, blurry vision, or decreased vision, increased sensitivity to light, or other visual changes after the injection.
• In some patients, it may increase eye pressure, with a possible development of glaucoma. This may not be noticeable; therefore, your doctor should monitor it during clinic visits.
• In most patients who have not yet undergone cataract surgery, it may cause a clouding of the natural lens of the eye (cataract) after treatment with Iluvien. If this occurs, your vision will decrease, and it is likely that you will need surgery to remove the cataract. Your doctor will help you decide when to undergo this surgery, but be aware that until you are ready for surgery, your vision may be as poor or worse than it was before receiving the Iluvien injection.
• Iluvien has not been studied in both eyes at the same time, and therefore it is not recommended. Your doctor should not inject Iluvien in 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 (corneal inflammation), or you may notice a change in the appearance of your eye in the front. Inform your doctor immediately if you observe anything unusual that may suggest the implant has moved.
• In patients with inflammation of the back of the eye, eye pressure may decrease, but this usually lasts for a few days after the injection. This may not be noticeable; therefore, your doctor should monitor it between 2 and 8 days after the injection and during 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.

Iluvien interaction with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

Pregnancy, lactation, and fertility

• The experience with the use of Iluvien in pregnant women or during lactation is limited; therefore, the possible risks are unknown.
• No data are available on fertility. However, since Iluvien is introduced directly into the eye, it is unlikely to cause 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 experience temporarily blurred vision. If this occurs, do not drive or use machines until this symptom disappears.

Your eye doctor will administer the Iluvien injection.

Iluvien is administered as a single injection into the eye. Your doctor will then regularly check your vision.

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

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

If the implant's effect is diluted and your doctor recommends it, another implant can be injected into the eye.This only applies if you are administered Iluvien for the treatment of diabetic macular edema.

If you have any other questions about the use of this medication, ask your doctor.

Like all medications, Iluvien may cause side effects, although not everyone will experience them.

With the administration of Iluvien, some side effects may occur, mainly in the eye. Occasionally, the injection may cause an infection within the eye, eye pain or redness, 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 eye redness, intermittent lights, and a sudden increase in floating shapes, partially blocked vision, decreased vision, or increased sensitivity to light after the injection. Other side effects may include an increase or decrease in intraocular pressure or a veil in the natural lens of the eye. An increase in intraocular pressure that damages the optic nerve (glaucoma) may be more likely if your pre-treatment intraocular pressure is above average. Your doctor will discuss the risks of this circumstance with you before treatment. In section 2 of this prospectus (Warnings and precautions), the symptoms you may experience and what to do if you experience these symptoms are described.

The following side effects may be observed with Iluvien:

Veryfrequent(may affect more than 1 in 10 people)

Increase in intraocular pressure, veil or cloud in the natural lens of the eye (cataract) or eye surgery to correct the cataract.

Frequent(may affect up to 1 in 10 people)

Increase in intraocular pressure that damages the optic nerve (glaucoma),retinal detachment,bleeding in the white part of the eye or within the eye, small particles or spots in vision (floaters),sensation of seeing through steam or fog, decrease in eye pressure causing sudden pain and blurry vision,loss of usual field of vision,eye pain or irritation, reduced vision or eye surgery to relieve increased intraocular pressure or to remove the gel-like material that fills the back of the eye,increase in proteins and cells in the front part of the eye due to inflammation, sensation of a foreign body in the eye, dry eye.

Rare(may affect up to 1 in 100 people)

Blockage of blood vessels in the back of the eye, growth of new blood vessels within the eye, ulcer in the white part of the eye, changes in the gel-like material that fills the back of the eye, a veil in the sac that holds the lens of the eye, eye redness, itching or infection in the eye, thinning of the white outer layer of the eye, eye trauma caused by the injection of the medication, unintended movement 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,inflammation of the surface of the eye (corneal inflammation),involuntary blinking, eye pain and discomfort with sudden onset of intense pain for moments associated with blurry vision, deposits in the outer layer of the eye, painful eye caused by a scratch on the ocular surface, eye swelling.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more informationon the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and the inner packaging after CAD.
• Store below 30?°C.
• Do not refrigerate or freeze.
• Do not open the container that contains the applicator until immediately before administration.
• Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need.This will help protect the environment.

Dispose of the applicator safely in a container for biohazardous sharp objects.

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.

Appearance of the product and contents of the package

Iluvien consists of a small, light brown tube (approximately 3.5 mm x 0.37 mm) that 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Alimera Sciences Europe Limited

77 Sir John Rogerson’s Quay

Dublin 2

Ireland

Responsible for manufacturing:

Millmount Healthcare Limited

Block-7, City North Business Campus

Stamullen

Co. Meath

K32 YD60

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

BRILL PHARMA, S.L.

C/ Munner, 8,

08022 Barcelona (Spain)

93 417 09 11

This medication is authorized in the following member states of the European Economic Area with the invented name “Iluvien”:

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

Last review date of this package insert: 07/2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

INDICATIONS FOR THERAPEUTIC USE

Iluvien is indicated for the treatment of:

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

CONTRAINDICATIONS

The intravitreal implant with Iluvien is contraindicated in the presence of pre-existing glaucoma or active or presumed ocular or periocular infection, including most viral keratitis and conjunctivitis, including herpes simplex epithelial keratitis, vaccinia, varicella, mycobacterial infections, and fungal infections.

Iluvien is contraindicated in patients with:

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

ADMINISTRATION

EXCLUSIVELY FOR INTRAVITREAL USE.

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

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

The procedure for injecting Iluvien is as follows:

1.An antibiotic eye drop may be administered before the operation, at the discretion of the treating ophthalmologist.

2.Immediately before the injection, administer a drop of topical anesthesia on the injection site (recommended in the inferotemporal quadrant), followed by a cotton-tipped applicator soaked in anesthetic, or by the subconjunctival administration of an appropriate anesthetic.

3.Administer 2-3 drops of an appropriate topical antiseptic in the inferior fornix. The eyelids may be rubbed with a cotton-tipped applicator soaked in the antiseptic. Place a sterile eyelid speculum. Have the patient look up, and place a cotton-tipped applicator soaked in the antiseptic on the injection site. Allow the antiseptic to dry for 30-60 seconds before injecting Iluvien.

4.The exterior of the container that contains the applicatorshould 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 to see if they are damaged.If they are damaged, do not use the unit.If they are acceptable, the assistant should remove the capwithout touching the interior surface.

5.Visually inspect the preloaded applicator through the viewing window to verify that there is a pharmaceutical implant inside.

6.Remove the applicator from the container with sterile gloves, 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 the injection, the tip of the applicator should be maintained above the horizontal plane to ensure that the implant is properly placed in the applicator.

7.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 (in the black curved marks next to 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 continue with this unit.

8.The ideal location of the implant is inferior to the optic disc, and posterior to the equator of the eye. Measure 4 mm in the inferotemporal direction from the limbus, with the help of a caliper.

9.Remove the protective cap of the needle carefully and inspect the tip to ensure it is not bent.

10.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 edge of the eyelid 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 that the button reaches the end of its path before withdrawing the needle.

11.Remove the eyelid speculum and perform an indirect ophthalmoscopy to verify the location of the implant, the adequate perfusion of the central retinal artery, and the absence of any other complications.

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

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

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