Lifitegrast ophthalmic (for the eyes) is used to treat symptoms of dry eye disease.

Lifitegrast ophthalmic may also be used for purposes not listed in this medication guide.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use your doses at regular intervals, about every 12 hours.

Do not use while wearing soft contact lenses. A preservative in lifitegrast ophthalmic could permanently stain the lenses. Use the medicine at least 15 minutes before inserting your contact lenses.

Wash your hands before using eye medication.

To apply 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 and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the number of drops your doctor has prescribed.

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

Store 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.

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

Usual Adult Dose for Eye Dryness/Redness:

5% ophthalmic solution: 1 drop instilled into each eye 2 times a day

Comments:
-Doses should be separated by approximately 12 hours.
-The single-use container may be used to instill 1 drop in both eyes, but should be discarded immediately after use.
-Contacts should be removed before administration, and may be reinserted after 15 minutes.

Use: Treatment of the signs/symptoms of dry eye disease (DED)

Usual Pediatric Dose for Eye Dryness/Redness:

17 years and older:
5% ophthalmic solution: 1 drop instilled into each eye 2 times a day

Comments:
-Doses should be separated by approximately 12 hours.
-The single-use container may be used to instill 1 drop in both eyes, but should be discarded immediately after use.
-Contacts should be removed before administration, and may be reinserted after 15 minutes.

Use: Treatment of the signs/symptoms of DED

You should not use lifitegrast if you are allergic to it.

Tell your doctor if you are pregnant or breastfeeding.

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

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

An overdose of lifitegrast ophthalmic 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.

Keep this medication in the container it came in, closed, and out of reach of children. Keep the containers in the foil pouch until you are ready to use them to protect them from light. Store it at room temperature and away from excess heat.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not use other eye medications unless your doctor tells you to.

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

lifitegrast ophthalmic may cause serious side effects. Stop using lifitegrast ophthalmic and call your doctor at once if you have:

• vision problems; or

• severe eye redness or irritation.

Common side effects of lifitegrast ophthalmic may include:

• blurred vision;

• eye irritation; o

• 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.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.