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Safety

What is EYLEA® (aflibercept) Injection?

EYLEA is a prescription medicine approved by the FDA for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in patients with DME. You should not use EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept.

Who should not use EYLEA?

Anyone who has an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA, including aflibercept, should not use EYLEA.

What should I tell my doctor before I receive EYLEA?

Before you receive EYLEA, tell your doctor about all your medical conditions, including allergies, and if you are

  • Pregnant or plan to become pregnant. It is not known if EYLEA will harm your unborn baby
  • Breastfeeding or plan to breastfeed. You and your doctor should decide if you will take EYLEA or breastfeed. You should not do both without talking to your doctor first

Tell your eye doctor about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal supplements.

What are the possible side effects of EYLEA?

There is a potential risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack or stroke in patients receiving EYLEA.

Serious side effects related to the injection procedure with EYLEA are rare but can occur including infection inside the eye and retinal detachment.

The most common side effects reported in patients receiving EYLEA are increased redness in the eye, eye pain, cataract, vitreous (gel-like substance) detachment, moving spots in the field of vision, and increased pressure in the eye.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA.

It is important that you contact your doctor right away if you think you might be experiencing any side effects, including eye pain or redness, light sensitivity, or blurring of vision, after an injection.

These are not all the possible side effects of EYLEA. Ask your doctor for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

General information about the safe and effective use of EYLEA

In the days following EYLEA administration, there is a risk of infection in the eye and retinal detachment (separation of retina from back of the eye). If the eye becomes red, sensitive to light, painful, or develops a change in vision, seek immediate care from your eye doctor.

You may have temporary visual problems after treatment with EYLEA. Do not drive or use machinery until your sight has recovered.

This information summarizes the safe and effective use of EYLEA. For more information, talk to your eye doctor. You can ask your eye doctor for information about EYLEA that is written for health professionals. For more information about EYLEA, see the full Prescribing Information for EYLEA or call 1-855-395-3248 and select Option 1 for EYLEA, then Option 2.