Eylea

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.

FDA pregnancy category C. It is not known whether aflibercept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether aflibercept passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

The most common Eylea side effects include:

• conjunctival hemorrhage (bleeding in the eye)
• eye pain
• cataract
• vitreous detachment
• vitreous floaters
• increased pressure in the eye

This is not a complete list of Eylea side effects. Ask your doctor or pharmacist for more information.

Serious side effects have occurred with Eylea injections. See "Drug Precautions" section.

Because Eylea is injected into the eye, only a very small amount of the drug reaches the bloodstream, making Eylea unlikely to interact with most medications. However, be sure to tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Before receiving Eylea, tell your doctor about all your medical conditions including if you:

• have an infection in or around your eye(s)
• have had a blood clot or stroke
• are allergic to any medication, food, or dyes
• are pregnant or breastfeeding

Tell your doctor about all the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

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 (4 weeks) injections. Eylea may be dosed once per month, but additional benefit was not seen with this dosing plan.

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):  The recommended dose for Eylea is 2 mg administered by injection in the eye every 2 months (8 weeks) following 5 initial monthly (4 weeks) injections. Eylea may be dosed once per month, but additional benefit was not seen with this dosing plan.

Diabetic retinopathy in patients with diabetic macular edema:  The recommended dose for Eylea is 2 mg administered by injection in the eye every 4 weeks (monthly) for the first 5 injections then followed by 2 mg once every 8 weeks (2 months).

If Eylea is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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.

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

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

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

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;

• increased sensitivity of your eyes to light;

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

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

Common side effects 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.

Recombinant humanized fusion protein; a vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF) antagonist.1 2 3

Absorption

Bioavailability

Following intravitreal injection, mean peak plasma concentration attained in 1–3 days; peak plasma concentration estimated to be >100-fold lower than concentration required to half-maximally bind systemic VEGF.1

Free aflibercept undetectable in plasma 2 weeks after intravitreal injection.1

No accumulation observed following repeated intravitreal injections (i.e., once every 4 weeks).1

Special Populations

Following intravitreal injection every 4 or 8 weeks, no differences in free plasma aflibercept concentrations observed between patients with mild, moderate, or severe renal impairment.1

Distribution

Extent

Not known whether aflibercept is distributed into milk.1

Elimination

Metabolism

Expected to undergo elimination through both target-mediated disposition via binding to free endogenous VEGF and via proteolysis.1

Half-life

Approximately 5–6 days following IV administration of doses of 2–4 mg/kg.1

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Have your eye pressure checked. Talk with your doctor.
• This medicine may raise the chance of very bad and sometimes deadly health problems caused by blood clots, like heart attack and stroke. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust before care begins, during care, and for 3 months after care ends.
• If you get pregnant while taking Eylea or within 3 months after your last dose, call your doctor right away.

Single-use, glass vial designed to provide 0.05 mL of 40 mg/mL of a clear, colorless to pale yellow solution (2 mg) for intravitreal injection.

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

It is not likely that other drugs you take orally or inject will have an effect on Eylea used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.