Xiidra (lifitegrast 5%) is an eye drop solution that is used twice daily in each eye to treat the signs and symptoms of dry eye disease (DED) in adults over the age of 17 years.

Xiidra works by preventing a certain protein called lymphocyte function-associated antigen-1 (LFA-1) on the surface of leukocytes (a type of blood cell), from binding to a type of adhesion molecule called ICAM-1 which may be overexpressed in corneal and conjunctival tissues in people with DED. The interaction between LFA-1 and ICAM-1 is associated with T-cell activation and migration and the secretion of inflammatory cytokines. By blocking this interaction, Xiidra may prevent the secretion of inflammatory cytokines which improves the symptoms of DED, although the exact way it works in DED is not known.

Xiidra was FDA approved on July 11, 2016.

There are no contraindications to the use of Xiidra.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Before you use Xiidra, tell your doctor if you:

• are using any other eye drops
• wear contact lenses
• are pregnant or plan to become pregnant. It is not known if Xiidra will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Xiidra passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Xiidra.

Xiidra is not approved for use by anyone younger than 17 years old.

Use Xiidra exactly as directed by your health care provider. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Xiidra is usually given as one drop in each eye twice per day (every 12 hours). Use your doses at regular 12 hour intervals.

Wash your hands before using the eye drops.

Do not use Xiidra eye drops while wearing contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

To apply the Xiidra eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the Xiidra eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Each single-use eye drop container is for only one use in both eyes. Throw away after one use, even if there is still some medicine left in it after using the eye drops

Store Xiidra eye drops at room temperature away from moisture, heat, and light. Keep the eye drop container in its original foil pouch until you are ready to use the medicine.

Wash your hands before using the eye drops.

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
• Instil one drop of Xiidra into each eye twice daily (approximately 12 hours apart).
• Close your eyes for 2 or 3 minutes with your head level, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the Xiidra eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Each container of Xiidra is for single use only. Throw away the container after putting the drops in each eye, even if some solution remains.

If you wear contact lenses, remove them before putting Xiidra drops into your eyes. You can reinsert them 15 minutes later.

Use Xiidra exactly as directed by your healthcare provider. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Before you use Xiidra, tell your doctor if you:

• are using any other eye drops
• wear contact lenses
• are pregnant or plan to become pregnant. It is not known if Xiidra will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Xiidra passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Xiidra.

Xiidra is not approved for use by anyone younger than 17 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up for the missed dose.

An overdose of Xiidra is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Do not use other eye medications unless your doctor tells you to. Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Xiidra, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• vision problems; or

• severe eye redness or irritation.

Common Xiidra side effects may include:

• blurred vision;

• eye discomfort;

• eye irritation;

• unusual or unpleasant taste in the mouth.

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.