Xiidra (Page 3 of 3)

This Instructions for Use has been approved by the U.S. Food and Drug Administration.Revised: June 2020
INSTRUCTIONS FOR USE XIIDRA® [ZYE-druh](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.
Important Information You Need to Know Before Using Xiidra:
  • 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.
  • 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 one drop of Xiidra in each eye two times each day (one drop in the morning and one 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, one 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 (see Figure A).

Figure AFigure A
  • Pull off one single-use container from the strip (see Figure B).
Figure B
(click image for full-size original)
Figure B

Step 2. Put the remaining strip of single-use containers back in the pouch (see Figure C).

Figure CFigure C
  • Fold the edge to close the pouch (see Figure D).
Figure DFigure D

Step 3. Hold the Xiidra container upright (see Figure E).

Figure EFigure E
  • Tap the top of the container until all of the solution is in the bottom part of the container (see Figure F).
Figure F
(click image for full-size original)
Figure F

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 (see Figure G).

Figure G
(click image for full-size original)
Figure G

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 one drop of Xiidra fall into the space between your lower eyelid and your eye. If a drop misses your eye, try again (see Figure H).

Figure H
(click image for full-size original)
Figure H

Step 9. Repeat Steps 5 to 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.

Distributed by: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936

T2020-89

PRINCIPAL DISPLAY PANEL

NDC 0078-0911-12

Rx Only

60 Single-Use
Containers:
12 pouches x 5 single-use
containers (0.2 mL each)

xiidra®
(lifitegrastophthalmic solution) 5%

NOVARTIS

Principal Display Panel NDC 0078-0911-12 xiidra®
(click image for full-size original)
XIIDRA lifitegrast solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0911
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIFITEGRAST (LIFITEGRAST) LIFITEGRAST 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM THIOSULFATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0911-12 12 POUCH in 1 CARTON contains a POUCH (0078-0911-05)
1 NDC:0078-0911-05 5 AMPULE in 1 POUCH This package is contained within the CARTON (0078-0911-12) and contains a AMPULE
1 0.2 mL in 1 AMPULE This package is contained within a POUCH (0078-0911-05) and a CARTON (0078-0911-12)
2 NDC:0078-0911-94 4 POUCH in 1 CARTON contains a POUCH (0078-0911-95)
2 NDC:0078-0911-95 5 AMPULE in 1 POUCH This package is contained within the CARTON (0078-0911-94) and contains a AMPULE
2 0.2 mL in 1 AMPULE This package is contained within a POUCH (0078-0911-95) and a CARTON (0078-0911-94)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208073 07/11/2016
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 08/2023 Novartis Pharmaceuticals Corporation

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