Lifitegrast Ophthalmic

Ophthalmic lifitegrast comes as a solution (liquid) to instill in the eyes. It is usually instilled in each eye twice a day, about 12 hours apart. Instill lifitegrast at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lifitegrast exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Lifitegrast eye drops come in single-use containers (small bottles to be used for one dose). Use the liquid from the container immediately after opening, and throw away the container with any remaining liquid in it when you are finished. Do not save the liquid left in the container for your next dose.

To instill the eye drops follow these steps:

1. Wash your hands thoroughly with soap and water.
2. Pull off one container of medication from the strip of containers. Put the rest of the containers back into the foil pouch.
3. Hold the container upright. Be sure that twist off tab is at the top of the container.
4. Open the container by twisting off the tab at the top of the container.
5. Avoid touching the dropper tip against your eye or anything else; eye drops and droppers must be kept clean.
6. While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
7. Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it.
8. Brace the remaining fingers of that hand against your face
9. While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
10. Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
11. Place a finger on the tear duct and apply gentle pressure.
12. Wipe any excess liquid from your face with a tissue.
13. Repeat steps 5- 12 to instill in the other eye. There is enough liquid in one container for both eyes.
14. Wash your hands to remove any medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Instill the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill a double dose to make up for a missed one.

>10%

Instillation site irritation (5-25%)

Dysgeusia (5-25%)

Reduced visual acuity (5-25%)

1-10%

Blurred vision (1-5%)

Conjunctival hyperemia (1-5%)

Eye irritation (1-5%)

Headache (1-5%)

Increased lacrimation (1-5%)

Eye discharge (1-5%)

Eye discomfort (1-5%)

Eye pruritus (1-5%)

Sinusitis (1-5%)

Contraindications

None

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 lifitegrast, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lifitegrast 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.

Pediatric

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.

Geriatric

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

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

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

lifitegrast 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 lifitegrast. Wait at least 15 minutes after using lifitegrast 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 lifitegrast 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 lifitegrast. 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 lifitegrast, 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.

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:

• Changes in vision
• eye irritation or discomfort

• 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:

• Change in taste
• loss of taste

• 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.

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 your doctor's instructions about any restrictions on food, beverages, or activity.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Keep the medication in the original foil pouch until ready to use. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.