Consumer Brief Summary
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) in Patients with DME
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). 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 • 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 risk of serious and sometimes fatal side effects related to blood clots, leading to heart attack
or stroke in patients receiving EYLEA • You may experience temporary visual problems after receiving EYLEA and also during and/or after the eye
doctor visits that will follow. Avoid driving or using machinery until your sight has recovered • 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 side effects 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 • Moving spots in the field of vision • Increased pressure in the eye • Vitreous (gel-like substance) detachment 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 concentrated at 40 mg/mL. It is provided in a 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 more information, talk to your eye doctor and see the full Prescribing Information at EYLEA.com.