ours 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 Xiidra.
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.
Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
US Patents: 9353088; 9216174; 9085553; 8592450; 8367701; 8168655; 8084047; 7928122; 7790743; 7745460; 7314938.
This Instructions for Use has been approved by the U.S. Food and Drug Administration
Issued: 07/2016
PRINCIPAL DISPLAY PANEL - 12 Pouch Carton
NDC-54092-606-01
xiidra™
(lifitegrast
ophthalmic solution) 5%
For Topical Application to the Eye
60 Single-Use
Containers:
12 pouches x 5 single-use
containers (0.2 mL each)
Rx Only
Shire
INGREDIENTS AND APPEARANCE
XIIDRA
lifitegrast solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54092-606
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIFITEGRAST (UNII: 038E5L962W) (LIFITEGRAST - UNII:038E5L962W) LIFITEGRAST 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM THIOSULFATE (UNII: HX1032V43M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54092-606-01 12 in 1 CARTON 07/11/2016
1 NDC:54092-606-06 5 in 1 POUCH
1 0.2 mL in 1 AMPULE; Type 0: Not a Combination Product
2 NDC:54092-606-02 12 in 1 CARTON 07/11/2016
2 NDC:54092-606-07 5 in 1 POUCH
2 0.2 mL in 1 AMPULE; Type 0: Not a Combination Product
3 NDC:54092-606-04 4 in 1 CARTON 07/11/2016
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