Tyalia®

What is it?

What Tyalia^® is and what it is used for?

Tyalia^® is a solution which is injected into the eye to treat some eye conditions such as:

• Neovascular (wet) age-related macular degeneration (known as wet AMD)
• Edema and Swelling of macula (central area of the retina) caused by diabetes
• Diabetic Retinopathy
• Macular edema following retinal vein occlusion

Aflibercept, the active substance in Tyalia^®, blocks the activity of a group of factors, known as Vascular Endothelial Growth Factor A (VEGF-A) and Placental Growth Factor (PlGF), which, in excess, trigger the abnormal formation of new blood vessels in the eye. These new blood vessels can cause the leak of blood components into the eye and eventual damage to tissues in the eye responsible for vision.

Tyalia^® has been shown to stop the growth of new abnormal blood vessels in the eye which often leak fluid or bleed. Tyalia^® can help to stabilize, and in many cases, improve the vision loss related to wet AMD.

It is worth noting that Tyalia^® may be given to you for other reasons. Talk with the doctor.

Contraindications

Tyalia^® should not be administered in following conditions:

Known hypersensitivity to aflibercept or any component of the formulation; current ocular or periocular infection; active intraocular inflammation

Important information

Talk with your doctor if you have the following conditions, BEFORE you take this drug:

• If you are allergic to Aflibercept or any part of the drug; allergic to any other drugs, foods or substances
• If you have an eye infection or swelling (inflammation) in the eye
• If you are pregnant or breast-feeding or plan to become pregnant or to breast-feed

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor about all of your drugs (prescription, OTC, vitamins, etc.) and health problems to make sure that it is safe for you to take this drug.

Do not start, stop, or change the dose of any drug without checking with your doctor.

Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects of Tyalia^® may include cataract, eye pain and conjunctival hemorrhage.

Tyalia^® may cause less common side effects which include:

• Injection site pain
• Bleeding at injection site
• Foreign body sensation of the eye
• Increased intraocular pressure
• Increased lacrimation
• Blurred vision
• Intraocular inflammation
• Eyelid edema/ inflammation
• Corneal edema
• Hypersensitivity reactions

*The side effects mentioned above may be possibly related to the injection procedure or to the medicine.

*If you get any side effects, especially serious side effects, talk to your doctor. This includes any possible side effects not listed above.

Storage

• Store Tyalia^® in refrigerator (2°C to 8°C) and in the original package in order to protect from light.
• Do not Freeze Tyalia^®.
• Keep this medicine out of the sight and reach of children.