Pronunciation:

lif-i-TEG-rast

Brand Names:

• Xiidra

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Lubricant, Ocular

Uses of This Medicine:

Lifitegrast eye drops are used to treat signs and symptoms of dry eye disease (DED).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lifitegrast eye drops in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lifitegrast eye drops in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Remove contact lenses before using this medicine. Wait at least 15 minutes after using this medicine before putting the contact lenses back in.

To use:

• Take a foil pouch out of the box. Open the pouch and remove the strip of single use containers. Pull off 1 single use container from the strip.
• Put the remaining strip back into the pouch and fold the edge to close the pouch.
• Hold the container upright and open it by twisting off the tab.
• Wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Once you have applied a drop to both eyes, throw away the opened single use container. Wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For dry eye disease:
    • Adults—One drop two times a day (12 hours apart) into each eye.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the single dose containers in the foil pouch until you are ready to use it.

Precautions While Using This Medicine:

Your eye doctor will want to examine your eyes at regular visits to make sure that this medicine is working properly and is not causing unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Changes in vision

eye irritation or discomfort

Less common

Blurred vision

redness of the white part of the eyes or inside of the eyelids

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in taste

loss of taste

Less common

Cough

discomfort or itching of the eyes

drainage from the eyes

fever

headache

pain or tenderness around the eyes and cheekbones

stuffy or runny nose

tightness of the chest

troubled breathing

watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.