Fluocinolone ophthalmic (for the eye) implant is a steroid medicine that is used to treat diabetic macular edema, a build-up of fluid in the retina that is caused by leaking blood vessels.

Iluvien is also used to treat posterior uveitis, inflammation that affects the back of the eye.

This implant slowly releases fluocinolone into the eye over a period of approximately 30 to 36 months.

Iluvien may also be used for purposes not listed in this medication guide.

You should not be treated with Iluvien if you have glaucoma, or any type of infection in or around your eye (including herpes).

You should not be treated with this medicine if you are allergic to fluocinolone, or if you have:

• glaucoma; or

• any type of infection in or around your eye.

The use of fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

Tell your doctor if you have ever had:

• glaucoma;

• herpes simplex;

• cataract surgery; or

• a detached retina.

Tell your doctor if you are pregnant. It is not known whether the Iluvien is harmful to an unborn baby if you receive the implant while you are pregnant. Tell your doctor right away if you become pregnant during the 36 months after you receive the implant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How is the Iluvien put into place?

A healthcare provider will surgically place the implant in your eye. If both eyes will be treated, your implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Your doctor may prescribe other medications to help control the pressure inside your eyes. Increased pressure inside the eye (also called ocular hypertension) can damage the optic nerve and lead to permanent blindness. You may need to continue using these other medications for several weeks.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or stop using your medications without your doctor's advice.

You may have a temporary decrease in vision. Call your doctor if your vision does not return to normal with 4 weeks after your implant was put in place.

Your eyes will need to be checked on a regular basis.

Iluvien will not correct vision problems you had before receiving the implant, such as near-sightedness or far-sightedness.

Since the Iluvien is surgically put into place, you will not be on a dosing schedule.

Since the fluocinolone implant contains a specific amount of the medication, you are not likely to receive an overdose.

Iluvien may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Do not use other eye medications unless your doctor tells you to.

Ask your doctor before wearing contact lenses after receiving the Iluvien.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Iluvien may cause serious side effects. Call your doctor at once if you have:

• blurred vision, tunnel vision, problems with peripheral (side) vision;

• eye redness, eye pain or swelling, seeing halos around lights;

• bleeding, oozing, or crusting of your eyes;

• flashes of light or "floaters" in your vision; or

• cloudiness in your pupil or iris (colored part of your eyes).

Common side effects of Iluvien may include:

• mild eye redness or pain;

• feeling like something is in your eye;

• headache; or

• your eyes may be more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.