Eylea

What is Eylea?

• Eylea (Aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor used for the treatment of wet age-related macular degeneration.
• It is also used to treat macular edema after retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Aflibercept (Eylea®)

What are the uses of this medicine?

Eylea (Aflibercept) used for the treatment of:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

How does this medicine work?

• Aflibercept acts as a soluble decoy receptor that binds VEGF-A and PlGF, and thereby can inhibit the binding and activation of these cognate VEGF receptors.
• Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells.
• VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
• PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes.
• Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• ocular or periocular infections
• active intraocular inflammation
• known hypersensitivity to aflibercept or any of the excipients in Eylea

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• In November 2011, the United States Food and Drug Administration (FDA) approved aflibercept for the treatment of wet macular degeneration.

How should this medicine be used?

Recommended dosage: Neovascular (Wet) Age-Related Macular Degeneration (AMD):

• The recommended dose for Eylea is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months).

Macular Edema Following Retinal Vein Occlusion (RVO):

• The recommended dose for Eylea is 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly).

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR):

• The recommended dose for Eylea is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months).

Administration:

• Aflibercept injection comes as a solution (liquid) to be injected into the eye by a doctor.
• It is usually given in a doctor's office.
• Your doctor will give you injections on a schedule that is best for you and your condition.
• Before you receive an aflibercept injection, your doctor will clean your eye to prevent infection and numb your eye to reduce discomfort during the injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 2 mg/0.05 mL solution in a single-dose pre-filled syringe
• Injection: 2 mg/0.05 mL solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Eylea

What side effects can this medication cause?

The most common side effects of this medicine include:

• conjunctival hemorrhage
• eye pain
• cataract
• vitreous detachment
• vitreous floaters
• intraocular pressure increased

Eylea can cause the following serious side effects:

• eye redness or pain
• eye sensitivity to light
• decrease or changes in vision
• bleeding in or around the eye
• seeing floaters or small specks
• injection site pain
• seeing flashes of lights
• dizziness or faintness
• weakness or numbness of an arm or leg
• rash
• itching
• hives
• difficulty breathing or swallowing
• chest pain
• shortness of breath
• sweating
• slow or difficult speech

What special precautions should I follow?

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors, including Eylea. There were no reported thromboembolic events in the patients treated with Eylea in the first six months of the RVO studies.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Adequate and well-controlled studies with Eylea have not been conducted in pregnant women.
• Eylea can cause fetal harm when administered to a pregnant woman.
• Eylea should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of Eylea in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• aflibercept

Inactive Ingredients:

• sodium phosphate
• sodium chloride
• polysorbate 20
• sucrose

Who manufactures and distributes this medicine?

Manufactured by:

• Regeneron Pharmaceuticals, Inc.
• 777 Old Saw Mill River Road
• Tarrytown, NY

• Eylea is a registered trademark of Regeneron Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Refrigerate Eylea at 2°C to 8ºC (36°F to 46ºF).
• Do not freeze.
• Do not use beyond the date stamped on the carton and container label.
• Store in the original carton until time of use to protect from light.
• Do not open sealed blister tray until time of use.

• Dailymed label info on Eylea
• FDA Eylea