Fluocinolone (Intraocular)

Fluocinolone acetonide intravitreal implant is used for diabetic patients with diabetic macular edema (DME). Macular edema is swelling in the back of the eye and can lead to vision loss. This medicine is for patients who have already 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) in the back part of the eye.

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

Your eye doctor will want to check how you are doing at regular visits, especially in the first few weeks after you receive this medicine.

Serious eye problems may happen after receiving this medicine. Contact your eye doctor immediately if you notice a change in your vision or if your eye becomes red, sensitive to light, or painful. Also, inform your doctor if you feel increased pressure in your eye.

Cataracts may develop after receiving this medicine. Contact your doctor right away if you experience 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 to a different part of your eye if the back part of your lens is missing or torn. Talk to your doctor if you have any concerns.

If your symptoms do not improve or if they get worse, contact your eye doctor immediately.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of fluocinolone acetonide implant in children. Safety and effectiveness have not been established.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the usefulness of fluocinolone acetonide implant.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

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

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Cataract or
• Detached retina (eye disorder) or
• Endophthalmitis (inflammation of the eye) or
• Glaucoma (increased pressure in the eye) or
• History of herpes infection of the eye—Use with caution. May worsen these conditions.

• Eye infection caused by a virus, fungus, or bacteria or
• Fungal eye infection or
• Advanced glaucoma 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.

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

In the U.S.

• Iluvien
• Retisert
• Yutiq

Available Dosage Forms:

• Implant

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Fluocinolone

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.

• What are the differences between Retisert, Iluvien and Yutiq intravitreal implants?