Aflibercept ophthalmic (for the eyes) is used to treat wet age-related macular degeneration. Aflibercept ophthalmic is also used to treat macular edema following retinal vein occlusion, a swelling in the retina caused by a blockage in the blood vessels.

Aflibercept ophthalmic is also used to treat diabetic retinopathy, an eye disorder in diabetics that can lead to a buildup of fluid in the retina and cause blindness. Aflibercept can also be used to treat diabetic macular edema, a build-up of fluid in the retina that is caused by leaking blood vessels.

Aflibercept ophthalmic is also used to treat retinopathy of prematurity, an eye condition of premature babies affecting the retina.

Aflibercept ophthalmic may also be used for purposes not listed in this medication guide.

You should not use aflibercept if you have swelling inside your eyes, or any type of infection in or around your eyes.

Call your doctor at once if you have eye pain or redness, swelling or puffiness around your eyes, or sudden vision problems at any time during treatment.

Aflibercept ophthalmic is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Aflibercept is given at different intervals, depending on the condition being treated with this medicine. Follow your doctor's dosing instructions very carefully.

Usual Adult Dose for Macular Degeneration:

2 mg via intravitreal injection every 4 weeks for the first 12 weeks, then 2 mg via intravitreal injection every 8 weeks
-Some patients may need to continue with every 4-week dosing after the first 12 weeks

Comments:
-Patients should be assessed regularly.
-Additional efficacy was not demonstrated for most patients when dosed every 4 weeks compared to every 8 weeks; however, some patients may need monthly dosing.
-After 1 year of effective therapy, patients may be treated with 2 mg via intravitreal injection every 12 weeks, although this regimen is not as effective as the recommended every 8-week dosing regimen.

Use: For the treatment of neovascular (wet) age-related macular degeneration.

Usual Adult Dose for Macular Edema:

Macular Edema following Retinal Vein Occlusion (RVO):
2 mg via intravitreal injection every 4 weeks

Diabetic Macular Edema (DME):
2 mg via intravitreal injection every 4 weeks for the first 5 injections (20 weeks), then 2 mg via intravitreal injection every 8 weeks
-Some patients may need to continue with every 4-week dosing after the first 20 weeks

Diabetic Retinopathy (DR):
2 mg via intravitreal injection every 4 weeks for the first 5 injections (20 weeks), then 2 mg via intravitreal injection every 8 weeks
-Some patients may need to continue with every 4-week dosing after the first 20 weeks

Comments:
-Patients should be assessed regularly.
-Additional efficacy was not demonstrated for most patients when dosed every 4 weeks compared to every 8 weeks; however, some patients may need monthly dosing.

Uses: For the treatment of macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

You should not use aflibercept if you are allergic to it, or if you have:

• swelling inside your eyes; or

• any type of infection (bacterial, fungal, viral) in or around your eyes.

Tell your doctor if you have ever had:

• a blood clot or stroke; or

• glaucoma or other condition that increase pressure inside your eyes.

Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy before your first dose of aflibercept ophthalmic. Keep using birth control during treatment and for at least 3 months after your last injection.

Do not breastfeed.

Call your doctor for instructions if you miss an appointment for your aflibercept injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

aflibercept ophthalmic may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your eyes, face, lips, tongue, or throat.

Aflibercept ophthalmic may cause serious side effects. Call your doctor at once if you have:

• eye pain or redness, swelling around your eyes;

• sudden vision problems;

• seeing flashes of light or "floaters" in your vision, seeing halos around lights;

• your eyes may be more sensitive to light;

• chest pain;

• sudden numbness or weakness, especially on one side of the body; or

• sudden severe headache, confusion, problems with speech or balance.

Common side effects of aflibercept ophthalmic may include:

• red or watery eyes;

• blurred vision;

• swelling of the eyelids; or

• mild eye pain or discomfort after the injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.