Important safety information about EYLEA Important safety information about EYLEA

Safety

See possible side effects, what you should tell your doctor before you receive EYLEA, and more.

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.

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 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

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
  • 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 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 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 important safety information listed under “What is the most important information I should know about EYLEA?”

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.

There are other possible side effects of EYLEA. For more information, see the full prescribing information for EYLEA, or 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 by call 1-800-FDA-1088.

WHERE CAN I LEARN MORE ABOUT EYLEA?

For more information, talk to your eye doctor and see the full Prescribing Information at EYLEA.com.

Download the discussion guide to help start the conversation with your doctor about retinal disease.

DISCUSSION GUIDES

Whether it's the first visit or you've already been diagnosed, these helpful guides may give you insight into more productive discussions with your eye care team.

APPOINTMENT & TREATMENT TIPS

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Tips to prepare for your eye appointment

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IMPORTANT SAFETY INFORMATION
  • EYLEA® (aflibercept) Injection is a prescription medicine administered by injection into the eye. 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.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • EYLEA is for prescription use only. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA.

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.

INDICATIONS

EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with 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.

Please see the full Prescribing Information for EYLEA.

The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.

For U.S. Residents Only

EYLEA AND EYLEA4U are registered trademarks of Regeneron Pharmaceuticals, Inc.

© 2019, Regeneron Pharmaceuticals, Inc. All rights reserved.
777 Old Saw Mill River Road,
Tarrytown, NY 10591

03/2019
US-LEA-14281b(1) US-LEA-14281b(1)

 

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