Indication
Indication: ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
Important Safety Information
- 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 glaucoma with a cup to disc ratio of greater than 0.8.
- You should not use ILUVIEN if you have a hypersensitivity to any components of this product.
- Injections into the vitreous in the eye are associated with a serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, glaucoma, and retinal detachments. Your eye doctor should monitor you regularly after the injection.
- Corticosteroids may increase secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of herpes viral infections of the eye.
- If the posterior capsule of the lens of your eye is missing or torn, the ILUVIEN implant may move to the front chamber of the eye.
- The most common side effects reported in patients with diabetic macular edema who were treated with corticosteroids, including ILUVIEN, include cataracts (ILUVIEN 82%; sham 50%) and increased eye pressure (ILUVIEN 34%; sham 10%).
- This safety information is not comprehensive. For additional safety information, please talk to your doctor and see the full Prescribing Information for ILUVIEN at old.iluvien.com.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.