Chattanooga Times Free Press

Is Diabetic Macular Edema getting in the way of your eyes?

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See how EYLEA may be able to help. On average, people with DME gained 10 more letters on the eye chart after 1 year on EYLEA in 2 clinical studies. Visit DiscoverEY­LEA.com/Parade or Call 833-EYLEA-TV

INDICATION­S

EYLEA® (aflibercep­t) Injection is a prescripti­on medicine approved for the treatment of patients with Wet Agerelated Macular Degenerati­on (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopath­y (DR) in patients with DME.

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.

Please see the Consumer Brief Summary on the adjacent pages.

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) 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.

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