190 micrograms intravitreal implant in applicator
fluocinolone acetonide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor.
  • If you get any side effects , talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Iluvia is and what it is used for
2. What you need to know before you use Iluvien
3. How Iluvien is given
4. Possible side effects
5. How to store Iluvien
6. Contents of the packaging and other information

1. What Iluvi is and what it is used for

Iluvia is a small tube that is inserted into the eye and releases very small amounts of the active substance fluocinolone acetonide for up to 3 years. Fluocinolone acetonide belongs to a group of medicines called corticosteroids .

Iluvia is used to treat vision loss due to diabetic macular edema when other available treatments have not helped. Diabetic macular edema is a condition that occurs in some people with diabetes and causes damage to the photosensitive layer at the back of the eye that is responsible for central vision, the yellow spot . The active substance (fluocinolone acetonide) helps to reduce the inflammation and swelling that build up in the macula in this condition. Iluvia can therefore help to improve the damaged vision or prevent it from deteriorating.

Iluvia is used to prevent recurrence of inflammation in the back of the eye. Inflammation can cause haze, ie black spots or thin lines that move across the field of vision or cause loss of vision by damaging the macula . Vision loss may not improve unless inflammation is treated. Iluvia helps reduce inflammation and swelling that can occur in the back of the eye, which can help improve your damaged vision or prevent it from deteriorating. Iluvia can prevent new inflammation .

Fluocinolone acetonide found in Iluvia may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Iluvia

You should not get Iluvien:

  • 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 or around the eye
  • if you have glaucoma (high pressure inside the eye).

Warnings and cautions

– Before your Iluvien injection , tell your doctor:

  • if you are taking any medicines that thin the blood
  • if you have had a herpes simplex infection in the eye before (a sore on the eye that has been there for a long time).

Iluvia is given as an injection into the eye. Sometimes an injection can cause an infection inside the eye, pain or redness in the eye or retinal detachment or rupture of the retina. It is important to identify and treat this as soon as possible. Tell your doctor immediately if you experience increased eye pain or discomfort, worsening redness in the eye, flashes of light and a sudden increase in floating dots or spots (clouds) in front of the eye, partially blocked field of vision , decreased vision or increased photosensitivity after injection .

– In some patients the eye pressure may increase with possible development of glaucoma ( glaucoma ). This is something you may not notice; therefore, you must be followed up by your doctor during a visit to the clinic.

– In most patients who have not yet undergone cataract surgery (cataracts), a cloudiness of the eye’s natural lens (a cataract ) may occur after treatment with Iluvia. If this happens, your vision will deteriorate and you will probably need surgery to remove the cataract . Your doctor will help you determine the most appropriate time to have this surgery, but you should be aware that until you are ready for the surgery, your vision may be as bad or worse than before you received the Iluvien injection .

– Injection of Iluvia into both eyes at the same time has not been studied and is not recommended. Your doctor should not inject Iluvien into both eyes at the same time.

– There is a risk that the Iluvien implant will move from the back of the eye to the front. The risk increases if you have undergone cataract surgery before. Distorted vision, other visual disturbances or changes in the appearance of the front of the eye may be a sign that the implant has moved to the front of the eye. Tell your doctor if you notice anything that makes you suspect that the implant has moved.

– In patients with inflammation in the back of the eye, the pressure in the eye may decrease, but this usually lasts only a few days after injection . This is something you may not notice yourself, and therefore the doctor must check you within 2-8 days and with subsequent visits to the clinic.

Children and adolescents (under 18 years)

The use of Iluvia in children and adolescents has not been studied and is therefore not recommended.

Other medicines and Iluvia

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breastfeeding and fertility

  • There is limited experience with the use of Iluvia in pregnant or lactating women and therefore the potential risks are unknown.
  • There are no data available on fertility . Because Iluvia is injected directly into the eye, it is unlikely to have any effects on male or female fertility .
  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

After treatment with Iluvia, you may experience some transient blurred vision. If this happens, do not drive or use machines until it has passed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How Iluvien is given

Iluvien injection will be given by your ophthalmologist.

Iluvia is given as a single injection into the eye. After that, your doctor will check your vision regularly.

Before injection one, the doctor will use eye drops with antibiotics and wash the eye thoroughly to prevent infection . Your doctor will also give you local anesthesia to prevent any pain that an injection may cause.

Before and after injection , your doctor may ask you to use eye drops with antibiotics to prevent any eye infection . Follow these instructions carefully.

If the effect of implant et decreases and your doctor recommends it, another implant may be injected into your eye. This only applies if you are receiving Iluvien for the treatment of diabetic macular edema.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

In connection with the administration of Iluvia, there may be some side effects , mainly in the eye. Sometimes an injection can cause an infection inside the eye, pain or redness in the eye or retinal detachment or rupture of the retina. It is important to identify and treat this as soon as possible. Tell your doctor immediately if you experience increased eye pain or discomfort, worsening redness in the eye, flashes of light and a sudden increase in floating dots or spots (clouds) in front of the eye, partially blocked field of vision , decreased vision or increased photosensitivity after injection . Other side effects may be increased or decreased pressure in the eye or turbidity of the eye’s natural lens. There may be an increased risk of increased pressure in the eye that damages the optic nerve ( glaucoma ) if the pressure inside the eye is higher than normal before treatment. Your doctor will discuss the risks of this with you before treatment. The symptoms that you may experience and what to do if you get these symptoms are described in section 2 of this leaflet (Warnings and Precautions).

The following side effects may occur with Iluvia:

Very common (affects more than 1 patient in 10)

Increased pressure in the eye, clouding of the eye’s natural lens ( cataract ) or eye surgery to correct a cataract .

Common (affects 1 to 10 users in 100)

Increased pressure in the eye that damages the optic nerve ( glaucoma ), detachment of the photosensitive layer at the back of the eye (retinal detachment), bleeding in the white of the eye or inside the eye, small particles or spots in the visual field (cloudiness), a feeling of seeing through haze or fog, decreased pressure in the eye that causes sudden pain and blurred vision, loss of your normal field of vision , pain or irritation in the eye, impaired vision, eye surgery or action to relieve the increased pressure in the eye or remove the gel that fills the back of eye, increased amount of protein and cells in the front of the eye due to inflammation , sensation of foreign objects in the eye, dry eyes.

Uncommon (affects less than 1 in 100 people)

Blockage of the blood vessels in the back of the eye, growth of new blood vessels inside the eye, sores on the whites of the eyes, changes in the gel that fills the back of the eye, clouding of the sac containing the eye lens, eye redness, itching or infection in the eye, thinning of white outer layer of the eye, damage to the eye by injection of the drug, unplanned movement of the implant through the whites of the eyes and / or other complications of the injection , movement of the Iluvian implant from the back to the front of the eye, involuntary closure of the eyelids, aching and sore eyes with sudden severe pain, sometimes associated with blurred vision, precipitations on the outermost layer of the eye, painful eye condition caused by a scratch on the surface of the eye, swollen eyes.

The most common non-visual side effect reported to be possibly caused by the drug or by injection is a headache.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store 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 inner carton after EXP.
  • Do not store above 30 ° C.
  • Store in a cold place. Do not freeze.
  • Do not open the sealed tray until just before administration .
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
  • Dispose of the applicator safely in a container for sharp objects and biological hazardous waste

6. Contents of the packaging and other information

Content declaration

  • The active substance is fluocinolone acetonide.
  • 1 intravitreal implant contains 190 micrograms of fluocinolone acetonide.
  • The other ingredients are polyvinyl alcohol.
  • The implant is a small tube made of polyimide and sealed with silicone glue at one end and polyvinyl alcohol at the other end.

What the medicine looks like and contents of the pack

The Iluvi consists of a small light brown tube (approximately 3.5 mm x 0.37 mm) which is preloaded in an applicator system. The pre-charged applicator is placed on a polycarbonate tray that is sealed with a peelable lid. 1 sealed tray is delivered in a box containing the package leaflet.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Alimera Sciences Europe Limited

77 Sir John Rogerson’s Quay

Dublin 2

Ireland

Manufacturer:

AndersonBrecon (UK) Ltd.

Forest Road

Hay-on-Wye

Hereford

Herefordshire HR3 5PG

UK

Millmount Healthcare Limited

Block-7, City North Business Campus

Stamullen

Co. Meath

K32 YD60

Ireland

Muhammad Nadeem

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