Retisert is an ophthalmic implant containing fluocinolone. Fluocinolone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Retisert ophthalmic implant is used to treat non-infectious posterior uveitis, inflammation that affects the back of the eye.

Retisert slowly releases fluocinolone into the eye over a period of approximately 30 months.

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

The Retisert implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Do not use any eye medications that your doctor has not prescribed. Retisert can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

For the first 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal after 4 weeks. Retisert will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.

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

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

• glaucoma; or

• any type of infection in or around your eye.

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

To make sure the Retisert implant is safe for you, 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 fluocinolone contained in an implant is harmful to an unborn baby if you use the implant while you are pregnant. Tell your doctor right away if you become pregnant during the 30 months after you receive the implant.

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

How is the Retisert ophthalmic implant put into place?

A healthcare provider will surgically place the Retisert 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.

For 1 to 4 weeks after receiving the implant, 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.

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

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

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

Retisert 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 Retisert.

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

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 Retisert side effects 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.