Pronunciation:

a-FLIB-er-sept - abzv

Brand Names:

• Enzeevu

Uses of This Medicine:

Aflibercept-abzv 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-abzv works by changing the amount of blood that gets to 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 have not been performed on the relationship of age to the effects of aflibercept-abzv injection 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-abzv 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
• Heart attack, history of or
• Increased pressure in the eye 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 progress closely 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 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 (eg, retinal detachment, endophthalmitis, increased pressure inside the eye, or retinal vasculitis with or without occlusion) may occur with this medicine. Check with your eye doctor right away if your 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 for blood clots. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty breathing, a severe, sudden headache, slurred speech, a sudden loss of coordination, severe weakness or numbness in the 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

change in vision

decreased vision

eye pain

loss of vision

redness of the eye

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

Less common

Pain at the injection site

sensitivity of the eyes to light

swelling of the eye

swelling of the eyelids

tearing

watering of the eyes

Rare

Chest tightness

fast heartbeat

hives, itching, skin rash

headache

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

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

trouble breathing or swallowing

Incidence not known

Chest pain or discomfort

nausea

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

pain or discomfort in the arms, jaw, back, or neck

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sweating

vomiting

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.