ILUVIEN Safety

Important Safety Information

Do not use ILUVIEN if you have or think you might have:
- an infection in or around the eyes, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.
- glaucoma with a cup to disc ratio of greater than 0.8.
- a hypersensitivity to any of the ingredients in ILUVIEN.

Warnings
- Injections into the gel-like substance between the lens and retina of the eye (vitreous) are associated with a serious eye infection (endophthalmitis), eye inflammation, increased or decreased eye pressure, glaucoma, and choroidal or retinal detachments. Your eye doctor should monitor you regularly after the injection.
- If your eye becomes red, sensitive to light, painful, or you notice a change in vision, seek immediate care from your doctor.
- You may experience temporary blurred vision after receiving an injection and should not drive or use machinery until your vision has resolved.
- Prolonged use of corticosteroids may result in the development of glaucoma and can cause changes in vision. Your eye doctor should regularly monitor your eye pressure. You may develop increased eye pressure and it may need to be managed with eye drops or surgery.
- The use of corticosteroids may cause: posterior subcapsular cataracts; delay corneal wound healing after cataract surgery; corneal and scleral thinning; and bacterial, viral, or fungal infections. Let your doctor know if you have a history of herpes viral infections of the eye as corticosteroids are not recommended in these patients.
- If the back part of the lens of your eye is missing or torn, the ILUVIEN implant may move to the front part of the eye.

Common side effects when using ILUVIEN for Diabetic Macular Edema
- The most common side effects in the eye were: cataracts, increased eye pressure, specks that float in the field of vision, eye pain, bleeding in the conjunctiva, clouding of the back of the eye’s lens capsule, eye irritation, separation of the gel-like substance inside of the eye (vitreous) from the retina, conjunctivitis, corneal swelling, foreign body sensation in eyes, itchy sensation in the eye, eye redness, damage to the optic nerve, eye discomfort, sensitivity to light, yellow or white spots on your retina, presence of white blood cells in the fluid behind the cornea, and eye discharge.
- The most common side effects not related to the eye were: anemia, headache, kidney failure, and pneumonia.

These are not all of the possible side effects of ILUVIEN. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to Alimera Sciences, Inc. at 1-844-445-8843 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

Approved Uses

ILUVIEN is a prescription medicine that is an implant injected into the middle of the eye (vitreous) and is used 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 significant increase in intraocular pressure.

Most common adverse reactions

Other serious side effects may include, but are not limited to:

Who should not use ILUVIEN?

Questions to ask your doctor about ILUVIEN.

Important Safety Information

Approved Uses

Important Safety Information

Approved Uses

ILUVIEN Safety

Most common adverse reactions

Other serious side effects may include, but are not limited to:

Who should not use ILUVIEN?

Questions to ask your doctor about ILUVIEN.

Important Safety Information

Approved Uses

Important Safety Information

Approved Uses

Possible Questions to Ask Your Doctor: