Pronunciation:

floo-oh-SIN-oh-lone a-SEET-oh-nide

Brand Names:

• Iluvien
• Retisert
• Yutiq

Dosage Forms:

• Implant

Classifications:

Therapeutic—

Corticosteroid, Intermediate

Pharmacologic—

Fluocinolone

Uses of This Medicine:

Fluocinolone acetonide intravitreal implant is used in diabetic patients who have diabetic macular edema (DME). Macular edema is swelling in the back of the eye and may cause vision loss. This medicine is used in patients who already have received steroid medicines and did not have an increase in intraocular pressure.

Fluocinolone acetonide intravitreal implant is also used to treat chronic non-infectious uveitis (redness, pain, or swelling of the eye that is not caused by infection) of the back part of the eye.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fluocinolone acetonide implant in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluocinolone acetonide implant in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin
• Bemiparin
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataract or
• Detached retina (eye disorder) or
• Endophthalmitis (inflammation of the eye) or
• Glaucoma (increased pressure in the eye) or
• Herpes infection of the eye, history of—Use with caution. May make these conditions worse.

• Eye infection caused by a virus, fungus, or bacteria or
• Fungal eye infection or
• Glaucoma, advanced or
• Herpes simplex infection of the eye or
• Mycobacterial eye infection or
• Vaccinia (smallpox) eye infection or
• Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Your eye doctor (ophthalmologist) will give you this medicine in a hospital or clinic. This medicine is an implant that is placed into your eye. It will stay into your eye and will not need to be removed for up to 3 years.

Precautions While Using This Medicine:

Your eye doctor will want to check your progress at regular visits, especially during the first few weeks after you receive this medicine.

Serious eye problems may occur after receiving this medicine. Check with your eye doctor right away if you have a change in vision or the eye becomes red, sensitive to light, or painful. Also, tell your doctor if you feel an increased pressure in the eye.

Cataracts may occur after receiving this medicine. Check with your doctor right away if you have blurred vision, decreased vision, or loss of vision.

This medicine may cause temporary blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This implant could move into a different part of your eye if the back part of your lens is missing or torn. Talk to your doctor if you have concerns.

If your symptoms do not improve or if they become worse, check with your eye doctor right away.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blindness

bloody eye

blurred vision

burning, dry, or itching eyes

change in color vision

decreased vision

difficulty seeing at night

discharge or excessive tearing

increased sensitivity of the eyes to sunlight

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Feeling of having something in the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.