Pronunciation:

a-FLIB-er-sept

Brand Names:

• Eylea

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Uses of This Medicine:

Aflibercept injection is used to treat neovascular (wet) age-related macular degeneration (AMD). AMD is a disorder of the retina in the eye that causes blurred vision or blindness. Aflibercept works by changing the amount of blood that gets to the retina.

Aflibercept injection is also used to treat macular edema after retinal vein occlusion. It is also used to treat diabetic macular edema (DME) and diabetic retinopathy. Macular edema is swelling in the back of the eye and may cause vision loss. Retinal vein occlusion is a blockage of a blood vessel in the eye. Swelling can occur when the blood vessel is blocked.

Aflibercept injection is also used to treat premature babies with retinopathy of prematurity (ROP). ROP happens when abnormal blood vessels grow in the retina.

This medicine is to be given only by your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Eylea® to treat retinopathy of prematurity in babies. Safety and efficacy have been established.

Appropriate studies have not been performed on the relationship of age to the effects of Eylea® HD in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aflibercept injection in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots, history of or
• Detached retina (eye disorder) or
• Endophthalmitis (inflammation of the eye) or
• Glaucoma (increased pressure in the eye) or
• Heart attack, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Eye infection or
• Eye swelling, active—Should not be used in patients with these conditions.

Proper Use of This Medicine:

An ophthalmologist (eye doctor) will give you this medicine as a shot into the eye.

Precautions While Using This Medicine:

Your eye doctor will want to check your or your child's progress closely and at regular visits, especially during the first few days after you receive this medicine, to make sure this medicine is working properly and to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control before the first dose, during treatment, and for 3 months for Eylea® or for 4 months for Eylea® HD after the last dose to keep from getting pregnant. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Serious eye problems may occur with this medicine. Check with your eye doctor right away if your or your child's eye becomes red, sensitive to light, or painful, or if you see flashes or sparks of light, have a change in vision, or feel increased pressure in the eye several days after the injection.

This medicine may increase your risk of blood clots. Check with your doctor right away if you or your child has pain in your chest, groin, or legs, especially the calves, difficulty with breathing, a severe, sudden headache, slurred speech, a sudden loss of coordination, severe weakness or numbness in your arm or leg, or vision changes.

This medicine may cause temporary blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blindness

bloody eye

blurred vision

eye or eyelid redness

eye pain

seeing flashes, sparks of light, or a veil or curtain

seeing floating spots before the eyes

vision changes

Less common

Bleeding or pain at the injection site

swelling of the eyelid

Rare

Chest tightness

fast heartbeat

fever

headache

hives, itching, rash, or skin redness

hoarseness

irritation

joint pain, stiffness, or swelling

swelling of the eye, face, lips, hands, or feet

trouble breathing or swallowing

Incidence not known

Pain in the chest, groin, or legs, especially the calves

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Feeling like something is in the eye

watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.