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Patient Information ILUVIEN® (ih-LOO-vee-in) (fluocinolone acetonide intravitreal implant) 0.19 mg


This information is not comprehensive and does not take the place of talking to your doctor about your medical condition or treatment. If you have any questions about ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg, ask your doctor. Only your doctor can determine if ILUVIEN is right for you. Visit www.iluvien.com to obtain the FDA-approved product labeling.


.............................................................................................................. What is ILUVIEN?


• ILUVIEN is a tiny implant injected into the back of the eye. It is designed to release a continuous low dose of steroid to the retina for 36 months. The medicine in ILUVIEN is called fluocinolone acetonide, a type of steroid called a corticosteroid. ILUVIEN is used for the treatment of the inflammation associated with diabetic macular edema (DME) in patients who have been treated with corticosteroids before and did not have a significant increase in eye pressure.


• It is not known if ILUVIEN is safe and effective in children less than 18 years of age.


.............................................................................................................. Who should not use ILUVIEN?


• Do not use ILUVIEN if you have or think you might have an infection in or around the eye.


• ILUVIEN should not be used if you have severe glaucoma.


• You should not use ILUVIEN if you are allergic to any ingredients of ILUVIEN (see complete list below). ..............................................................................................................


What should I tell my doctor before using ILUVIEN? Tell your doctor if you:


• are pregnant or plan to become pregnant. It is not known if ILUVIEN can harm your unborn baby.


• are breastfeeding or plan to breastfeed. It is not known if


ILUVIEN passes into your breast milk. .............................................................................................................. How should ILUVIEN be used?


• A retina specialist will insert a single ILUVIEN implant in your eye during an in-office procedure. The eye is numbed prior to the procedure, and then the implant is delivered via a tiny needle. No surgery or hospital stay is typically required. And there are no stitches. Following ILUVIEN treatment, your doctor will schedule periodic appointments to monitor your condition.


.............................................................................................................. What are some of the possible side effects of ILUVIEN? The use of ILUVIEN may cause serious side effects including:


• serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments.


• cataracts, glaucoma, and increased secondary eye infections due to bacteria, fungi, or viruses.


• the ILUVIEN implant moving to the front of the eye if the posterior capsule of the lens of your eye is missing or torn.


The most common eye-associated (ocular) side effects reported in patients with DME who were treated with ILUVIEN include:


• cataracts. If a cataract occurs, your vision will decrease and you will need cataract surgery to restore your vision.


• increased eye pressure, which may progress to glaucoma. Increase in eye pressure can be treated with eye pressure- lowering medications (usually eye drops). However, some people may require eye surgery to treat their increased eye pressure.


The most common side effects not associated with the eye (nonocular) reported in patients with DME who were treated with ILUVIEN include:


• decrease in the amount of red blood cells or hemoglobin in the blood (anemia).


• headache. • kidney (renal) failure. • pneumonia.


These are not all the possible side effects with ILUVIEN. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects to the FDA.


Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. .............................................................................................................. General information about ILUVIEN


• Medicines are sometimes prescribed for purposes other than those listed in their package inserts. This is a Brief Summary of important information about ILUVIEN. Ask your doctor or pharmacist for more complete product information, or visit www.ILUVIEN.com, or call 1-844-445-8843.


What are the ingredients in ILUVIEN? • Active ingredient: 0.19 mg fluocinolone acetonide.


• Inactive ingredients: polyimide tube, polyvinyl alcohol, silicone adhesive, and water for injection.


.............................................................................................................. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg


Manufactured for: Alimera Sciences, Inc. 6120 Windward Parkway Alpharetta, GA 30005 See: www.alimerasciences.com


All Rights Reserved. ILUVIEN is a registered trademark of Alimera Sciences, Inc.


Copyright ©2017 Alimera Sciences, Inc. All Rights Reserved. 1-844-445-8843. Printed in USA. US-ILV-MMM-0515. 11/2017


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