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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 people receiving EYLEA are increased redness in the eye, eye pain, cataract, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.

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 2.

Important Safety Information
  • EYLEA® (aflibercept) Injection is a prescription medication 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.
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Important Safety Information
  • EYLEA® (aflibercept) Injection is a prescription medication 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, moving spots in the field of vision, increased pressure in the eye, and vitreous (gel-like substance) detachment.
  • 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): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 3 months (12 weeks).
  • Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).
  • Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME: The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (every 4 weeks) injections. EYLEA may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. Some patients may need monthly (every 4 weeks) dosing after the first 5 months (20 weeks).
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.