(ZYE-druh) (lifitegrast) Ophthalmic Solution 5%
What is Xiidra?
Xiidra is a prescription eye drop solution used to treat
the signs and symptoms of dry eye disease.
It is not known if Xiidra is safe and effective in
children under 17 years of age.
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.
How should I use Xiidra?
See the complete Instructions for Use at the end of this
Patient Information leaflet for detailed instructions about the right way to
- Use Xiidra as your doctor tells you.
- Use 1 drop of Xiidra in each eye, 2 times each day, about
12 hours apart.
- Use Xiidra right away after opening. Throw away the
single-use container and any unused solution after you have applied the dose to
both eyes. Do not save any unused Xiidra for later.
What are the possible side effects of Xiidra?
The most common side effects of Xiidra include eye
irritation, discomfort, or blurred vision when the drops are applied to the
eyes, and an unusual taste sensation (dysgeusia).
Tell your doctor if you have any side effects that bother
you. These are not all the possible side effects of Xiidra.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store Xiidra?
- Store Xiidra at room temperature between 68°F to 77°F
(20°C to 25°C).
- Store Xiidra in the original foil pouch to protect it
- Do not open the Xiidra foil pouch until you are ready to
use the eye drops.
- Return unused single-use containers to their original
foil pouch to protect from excessive light exposure.
Keep Xiidra and all medicines out of the reach of
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. You can ask your pharmacist
or doctor for information about Xiidra that is written for health
professionals. Do not use Xiidra for a condition for which it was not
prescribed. Do not give Xiidra to other people, even if they have the same symptoms
you have. It may harm them.
What are the ingredients in Xiidra?
Active ingredient: lifitegrast
Inactive ingredients: sodium chloride, sodium phosphate
dibasic anhydrous, sodium thiosulfate pentahydrate, sodium hydroxide and/or
hydrochloric acid (to adjust pH) and water for injection.
Instructions for Use
(lifitegrast ophthalmic solution) 5% for topical ophthalmic use
Read this Instructions for Use before you start using
Xiidra™ and each time you get a refill. There may be new information. This
leaflet does not take the place of talking to your doctor about your medical
condition or your treatment.
- Xiidra is for use in the eye.
- Wash your hands before each use to make sure you do not
infect your eyes while using Xiidra
- If you wear contact lenses, remove them before using
- Xiidra single-use containers are packaged in a foil
pouch. Do not remove from the foil pouch until you are ready to use Xiidra.
- Do not let the tip of the Xiidra single-use container
touch your eye or any other surfaces.
- Use 1 drop of Xiidra in each eye 2 times each day (1 drop
in the morning and 1 drop in the evening, approximately 12 hours apart). Each
single-use container of Xiidra will give you enough medicine to treat both of
your eyes, 1 time. There is some extra Xiidra in each single-use container in
case you miss getting a drop into your eye. After you have applied the drops,
throw away the single-use container and any unused Xiidra. Do not save any unused
Follow Steps 1 to 9 each time you use Xiidra:
Step 1. Take a foil pouch out of the Xiidra box.
Open the pouch and remove the strip of single-use containers. Pull off 1
single-use container from the strip.
Step 2. Put the remaining strip of single-use
containers back in the pouch and fold the edge to close the pouch.
Step 3. Hold the Xiidra container upright. Make
sure that the Xiidra solution is in the bottom part of the container.
Step 4. Open the Xiidra single-use container by
twisting off the tab. Make sure that the tip of the single-use container does not
touch anything, to avoid contamination.
Step 5. Tilt your head backwards. If you are not
able to tilt your head, lie down.
Step 6. Gently pull your lower eyelid downwards
and look up.
Step 7. Place the tip of the Xiidra single-use
container close to your eye, but be careful not to touch your eye with it.
Step 8. Gently squeeze the single-use container
and let 1 drop of Xiidra fall into the space between your lower eyelid and your
eye. If a drop misses your eye, try again.
Step 9. Repeat steps 5-8 for your other eye. There
is enough Xiidra in one single-use container for both eyes.
Once you have applied a drop to both eyes, throw away the
opened single-use container with any remaining solution. If you use contact
lenses, wait for at least 15 minutes before placing them back in your eyes.