Consumer Brief Summary
This summary contains risk and safety information for patients about EYLEA. It does not include all the information about EYLEA and does not take the place of talking to your eye doctor about your medical condition or treatment.
What is EYLEA?
EYLEA is a prescription medicine that works by blocking vascular endothelial growth factor (VEGF). VEGF can cause fluid to leak into the macula (the light-sensitive tissue at the back of the eye responsible for sharp central vision). Blocking VEGF helps reduce fluid from leaking into the macula.
What is EYLEA used for?
EYLEA is indicated for the treatment of patients with: • Neovascular (Wet) Age-Related Macular Degeneration (AMD) • Macular Edema Following Retinal Vein Occlusion (RVO) • Diabetic Macular Edema (DME) • Diabetic Retinopathy (DR)
How is EYLEA given?
EYLEA is an injection administered by your eye doctor into the eye. Depending on your condition, EYLEA injections are given on different schedules. Consult with your eye doctor
to confirm which EYLEA schedule is appropriate for you.
Who should not use EYLEA?
Do not use EYLEA if you have an infection in or around the eye, eye pain or redness, inflammation in the eye, or are allergic to aflibercept and/or any other ingredients in EYLEA.
What is the most important information I should know about EYLEA?
• EYLEA must only be administered by a qualified eye doctor. Injection into the eye
with EYLEA can result in an infection in the eye and retinal detachment (separation of retina from back of the eye) can occur. Inflammation in the eye has been reported
with the use of EYLEA. If your eye becomes red, sensitive to light, painful, or develops a change in vision, seek immediate care from an eye doctor • In some patients, injections with EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your eye doctor may monitor this after each injection • There is a potential but rare 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 • You may experience temporary visual changes after an EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers
sufficiently • Because EYLEA is composed of large molecules, your body may react to it; therefore,
there is a potential for an immune response (allergy-like) in patients treated with EYLEA
What are possible side effects of EYLEA?
EYLEA can cause serious side effects, including
• See important safety information listed under “What is the most important information I should know about EYLEA?”
The most common side effects include • Increased redness in the eye • Eye pain • Cataract • Vitreous (gel-like substance) detachment • Vitreous floaters • Moving spots in the field of vision • Increased pressure in the eye
There are other possible side effects of EYLEA. For more information, ask your eye doctor.
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.
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.
What should I tell my eye doctor before receiving EYLEA?
• Tell your eye doctor if you have any medical conditions
• Tell your eye doctor if you are pregnant or are planning to become pregnant. It is not known if EYLEA may harm your unborn baby • Tell your eye doctor if you are breastfeeding. It is not known if EYLEA may harm your
baby. You and your eye doctor should decide whether you should be treated with EYLEA or breastfeed, but you should not do both
How is EYLEA supplied?
EYLEA is supplied in a clear, colorless to pale yellow solution. It is provided in a pre-filled glass syringe or glass vial containing the amount of product required for a single injection into the eye, which is 0.05 mL (or 2 mg of the medicine product).
Where can I learn more about EYLEA?
For a more comprehensive review of EYLEA safety and risk information, talk to your health care provider and see the full Prescribing Information at EYLEA.com.