NDA 208073
`
`Page 5
`
`HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use XIIDRA
`safely and effectively. See full prescribing information for XIIDRA.
`
`XIIDRATM (lifitegrast ophthalmic solution) 5%, for topical ophthalmic
`use
`
`Initial U.S. Approval: 2016
`
`INDICATIONS AND USAGET
`Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte
`function-associated antigen-1 (LFA-1) antagonist indicated for the treatment
`of the signs and symptoms of dry eye disease (DED). (1)
`
`-DOSAGE AND ADMINISTRATION
`One drop twice daily in each eye (approximately 12 hours apart). (2)
`
`W€\-BU3l~)b—I
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`INDICATIONS AND USAGE
`DOSAGE AND ADMINISTRATION
`DOSAGE FORMS AND STRENGTHS
`CONTRAINDICATIONS
`ADVERSE REACTIONS
`6.1 Clinical Studies Experience
`USE IN SPECIFIC POPULATIONS
`8.1 Pregnancy
`8.2 Lactation
`8.4 Pediatric Use
`8.5 Geriatric Use
`
`DOSAGE FORMS AND STRENGTHSTT
`Ophthalmic solution containing lifitegrast 5% (50 mg/mL). (3)
`
`----------——---—----—---——-CONTRAINDICATIONS--——---------——-——----
`None (4)
`
`TADVERSE REACTIONS
`The most common adverse reactions (incidence 5-25 %) following the use of
`Xiidra were instillation site irritation, dysgeusia and decreased visual acuity.
`(6)
`
`To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc.
`at 1-800-828-2088 or FDA at 1-800-FDA-1088 or
`www.fda.gov./medwatch.
`
`See 17 for PATIENT COUNSELING INFORMATION and
`FDA-approved patient labeling.
`
`Revised: 06/2016
`
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1
`Mechanism of Action
`12.3
`Pharmacokinetics
`13 NONCLINICAL TOXICOLOGY
`13.1
`Carcinogenesis, Mutagenesis, Impairment of Fertility
`14 CLINICAL STUDIES
`16 HOW SUPPLIED/STORAGE AND HANDLING
`17 PATIENT COUNSELING INFORMATION
`
`*Sections or subsections omitted from the full prescribing information are
`not listed.
`
`Reference ID: 3957400
`
`1
`
`ALL 2044
`MYLAN PHARMACEUTICALS V. ALLERGAN
`IPR2016-01128
`
`

`

`NDA 208073
`
`Page 6
`
`FULL PRESCRIBING INFORMATION
`
`1
`
`INDICATIONS AND USAGE
`
`XiidraTM (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye
`disease (DED).
`
`2
`
`DOSAGE AND ADMINISTRATION
`
`Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container.
`Discard the single-use container immediately after using in each eye.
`
`Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following
`administration.
`
`3
`
`DOSAGE FORMS AND STRENGTHS
`
`Ophthalmic solution containing lifitegrast 5% (50 mg/mL).
`
`4
`
`CONTRAINDICATIONS
`
`None.
`
`6
`
`ADVERSE REACTIONS
`
`6.1 Clinical Studies Experience
`Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical
`studies of a drug carmot be directly compared to rates in the clinical trials of another drug and may not reflect the rates
`observed in practice.
`
`In five clinical studies of dry eye disease conducted with lifitegrast ophthalmic solution, 1401 patients received at
`
`least 1 dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had 33 months of
`treatment exposure. 170 patients were exposed to lifitegrast for approximately 12 months. The majority of the treated
`patients were female (77%). The most common adverse reactions reported in 5-25 % of patients were instillation site
`irritation, dysgeusia and reduced visual acuity.
`
`Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye
`irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
`
`8
`
`USE IN SPECIFIC POPULATIONS
`
`8.1
`
`Pregnancy
`
`Risk Summa;v_
`There are no available data on Xiidra use in pregnant women to inform any drug associated risks. Intravenous (IV)
`administration of lifitegrast to pregnant rats, fiom pre-mating through gestation day 17, did not produce teratogenicity
`at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during
`organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the
`human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve
`[AUC] level). Since human systemic exposure to lifitegrast following ocular administration of Xiidra at the RHOD is
`low, the applicability of animal findings to the risk of Xiidra use in humans during pregnancy is unclear [see Clinical
`Pharmacology (1 2. 3)] .
`
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`NDA 208073
`
`Page 7
`
`Data
`
`Animal Data
`
`Lifrtegrast administered daily by intravenous (IV) injection to rats, fiom pre-mating through gestation day 17, caused
`an increase in mean preimplantation loss and an increased incidence of several minor skeletal anomalies at
`30 mg/kg/day, representing 5,400-fold the human plasma exposure at the RHOD of Xiidra, based on AUC. No
`teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the RHOD, based on
`AUC). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day
`(400-fold the human plasma exposure at the RHOD, based on AUC), when administered by IV injection daily fiom
`gestation days 7 through 19. A fetal No Observed Adverse Effect Level (NOAEL) was not identified in the rabbit.
`
`8.2
`
`Lactation
`
`Risk Summary
`There are no data on the presence of lif1tegrast in human milk, the effects on the breastfed infant, or the effects on
`milk production. However, systemic exposure to lif1tegrast from ocular administration is low [see Clinical
`Pharmacology (12. 3)]. The developmental and health benefits of breastfeeding should be considered, along with the
`mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child fiom Xiidra.
`
`8.4
`
`Pediatric Use
`
`Safety and efficacy in pediatric patients below the age of 17 years have not been established.
`
`8.5
`
`Geriatric Use
`
`No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
`
`11
`
`DESCRIPTION
`
`The chemical name for lif1tegrast is (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-
`carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid. The molecular formula of lifitegrast is C29H24Cl2N2O7S
`and its molecular weight is 615.5. The structural formula of lifitegrast is:
`
`* Chiral center
`
`Lifitegrast is a white to off-white powder which is soluble in water.
`
`Xiidra (lifrtegrast ophthalmic solution) 5% is a lymphocyte fiinction-associated antigen-l ( LFA-1) antagonist
`supplied as a sterile, clear, colorless to slightly brownish-yellow colored, isotonic solution of lifitegrast with a pH of
`7.0-8.0 and an osmolality range of 200-330 mOsmol/kg.
`
`Xiidra contains Active: lif1tegrast 50 mg/mL; Inactives: sodium chloride, sodium phosphate dibasic anhydrous,
`sodium thiosulfate pentahydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.
`3
`
`Reference ID: 3957400
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`NDA 208073
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`Page 8
`
`12
`
`CLINICAL PHARMACOLOGY
`
`12.1 Mechanism of Action
`
`Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on
`leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1).
`ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can
`contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues.
`In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may
`inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of
`action of lifitegrast in dry eye disease is not known.
`
`12.3
`
`Pharmacokinetics
`
`In a subset of dry eye disease patients (n=47) enrolled in a Phase 3 trial, the pre-dose (trough) plasma concentrations
`of lifitegrast were measured after 180 and 360 days of topical ocular dosing (1 drop twice daily) with Xiidra
`(lifitegrast ophthalmic solution) 5%. A total of nine (9) of the 47 patients (19%) had plasma lifitegrast trough
`concentrations above 0.5 ng/mL (the lower limit of assay quantitation). Trough plasma concentrations that could be
`quantitated ranged fiom 0.55 ng/mL to 3.74 ng/mL.
`
`13
`
`NONCLINICAL TOXICOLOGY
`
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`Carcinogenesis
`Animal studies have not been conducted to determine the carcinogenic potential of lifitegrast.
`
`Mutagenesis
`Lifitegrast was not mutagenic in the in vitro Ames assay. Lifitegrast was not clastogenic in the in vivo mouse
`micronucleus assay. In an in vitro chromosomal aberration assay using mammalian cells (Chinese hamster ovary
`cells), lifitegrast was positive at the highest concentration tested, without metabolic activation.
`
`Imgairment of tertiligy
`Lifitegrast administered at intravenous (IV) doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at
`the recommended human ophthalmic dose (RHOD) of lifitegrast ophthalmic solution, 5%) had no effect on fertility
`and reproductive performance in male and female treated rats.
`
`14
`
`CLINICAL STUDIES
`
`The safety and efficacy of lifitegrast for the treatment of dry eye disease were assessed in a total of 1181 patients
`(1067 of which received lifitegrast 5%) in four 12-week, randomized, multi-center, double-masked, vehicle-controlled
`studies. Patients were randomized to Xiidra or vehicle (placebo) in a 1:1 ratio and dosed twice a day. Use of artificial
`tears was not allowed during the studies. The mean age was 59 years (range, 19-97 years). The majority of patients
`were female (76%). Enrollment criteria included, minimal signs (i.e., Corneal Fluorescein Staining (CFS) and
`non-anesthetized Schirrner Tear Test (STT)) and symptoms (i.e., Eye Dryness Score (EDS) and Ocular Discomfort
`Score (ODS)) severity scores at baseline.
`
`Efiects on Symptoms of Dgjy Eye Disease
`Eye dryness Score (EDS) was rated by patients using a visual analogue scale (VAS) (0 = no discomfort, 100 =
`maximal discomfort) at each study visit. The average baseline EDS was between 40 and 70. A larger reduction in
`EDS favoring Xiidra was observed in all studies at Day 42 and Day 84 (see Figure 1).
`
`Reference ID: 3957400
`
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`NDA 208073
`
`Page 9
`
`Figure 1: Mean Change (SD) from Baseline and Treatment Difference (Xiidra — Vehicle) in Eye Dryness Score in 12-Week
`Studies in Patients with Dry Eye Disease
`Smdyi
`
`t
`Difference[ 1
`Xiidra
`Vehicle
`Diflerencem
`Xiidra
`'1.-'edi-cie
`(95% Cl)
`1N = 2931
`(N = 2951
`V1511.
`195% C11
`[N = 5-13 1
`(N : 53 1
`Visit
` " FBVCNY: Klldfa " FBVOIS Xllia
`Baseline
`51 8123.55]
`51.B(24.691
`Baseline
`41 6129.69)
`40 2128.641
`
`Sliudy 2
`
`Day 14
`Day-i2
`Dai_i8-'l
`
`-39125461
`-r.9i19i3oi
`1212529;
`
`-8.9121 mi
`-1‘.-'3(24=3i5i
`-14.d(25..'5B)
`
`.51 1.131, 301
`.94i.17ci_ -19)
`.r3:.1e.1_ 14)
`
`Da'i114
`Day-12
`Dag.-84
`
`.7599 B11
`.9i[:ioo3i
`-‘112[28.i'B)
`
`em? 3431
`-125130111
`.152m 431
`
`011-39 -1 1i
`421.35. uni
`.4 1'1-8.9, .04;
`
`-2121
`
`10
`
`0 5
`
`20
`
`-10
`
`0
`
`5
`
`1
`Shady I
`Study J
`I
`Difference! 1
`Xiidra
`Vehicle
`U'1flEfEl'|CE[ ]
`xiidra
`Vehicle
`V1511
`V1511
`195°»; cii
`in : 355 i
`(N : 355 i
`195% cu
`[N : 3551
`(N = 3:50 i
`-T-4- ~— Favors Xiidra -4444 v- Favors Xiidra
`Baseiiiie
`692116761
`697116951
`5
`B-aseiirie
`69C1[1?‘03i
`611.3116 831
`'
`
`Day 14
`Day #2
`Day 8-!
`
`-13.112-104)
`-18.2125 511
`-22.8123 60)
`
`-197126.-191
`-28 3121.691
`-35.3123 -101
`
`-2 31
`-E1-11-101).
`-111.01-13 3 431)
`-12 31-16.-1,
`-B 3)
`
`—+—-
`---o--
`—o—
`12121:!
`-10
`-20
`O 5
`
`Day 14
`Day-12
`Day 84
`
`-149122 35)
`-23 1' [$5.98)
`-30.5 [28 031
`
`-221125 -111
`-33 D (21.4-E11
`-3? ? (28 911
`
`-B111-114. 451
`-9 61-13 4. -5 B)
`-1‘ 51-116. -3.51
`
`-—o—-
`—o---
`-0-
`1221:!
`-10
`-20
`CI
`5
`
`:
`
`[1] Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4.
`All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one Xiidra treated subject who did not
`have a baseline value was excluded from analysis.
`
`Eflects on Signs 01 D52 Eye Disease
`Inferior fluorescein corneal staining score (ICS S) (0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and
`countable lesions, 3 = lesions too numerous to count but not coalescent, 4 = coalescent) was recorded at each study
`visit. The average baseline ICSS was approximately 1.8 in Studies 1 and 2, and 2.4 in Studies 3 and 4. At Day 84, a
`larger reduction in ICSS favoring Xiidra was observed in three of the four studies (see Figure 2).
`
`Figure 2: Mean Change (SD) from Baseline and Treatment Difference (Xiidra — Vehicle) in Inferior Corneal Staining Score in
`12-Week Studies in Patients with Dry Eye Disease.
`511.1651!
`
`Shad? 2
`
`Diifeiieriicem
`Xiima
`Vehicle
`Diflerencem
`Xiidra
`Vehicle
`Visit
`'Ii'i5i1
`195% CI]
`[N = 293]
`W = 295]
`195% 011
`{N = 53 J
`(N = 5-8)
` -— Favors Xiidra - Fainioiisxildra
`
`Base-like
`D311-1
`Da'r-1-2
`Uairfi-I
`
`16510 513)
`12124 11] 7091
`121 19113 694)
`E1 3810 I351
`
`1 ?'71U 5151
`11061135221
`0121310 591}
`0.134113 I451
`
`-1'.) 141-1136, DOB)
`43051-0 28.
`1'1 11')
`-121 251-121 5121. -U 0131)
`
`Baseline
`Day-14
`Day -12
`Dar E14
`
`1 51 10.599)
`0121310 1'71)
`-0 0210 893)
`01110 E119)
`
`1 B4 :10 59.?)
`0.0-! 10 1'3-41
`-D1-i1C1.E16-11
`-121 CI? 10 B581
`
`«1J.IZ1I31-D 14, DOB}
`-121 101-12123. E102}
`-11231’-0 36.-D10)
`
`—o— :
`are
`.050
`01210
`I125
`
`T-i-:1
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`D01] 025
`
`8t1.idy4
`away 3
`Uifferencel
`Xiidra
`Vehicle
`i
`Diflerericel
`Xiidra
`Venue
`'|.|'i5it
`'-i"i*:ia1
`195% CI]
`[N = 355}
`1N : 356)
`(95% Cl)
`{N = 353]
`(N = 350 I
` 0- Favors xlldfa - v— FBVDTS Xiidra
`Base-me
`2 4010 722)
`2.3911] F53}
`j
`Baseline
`2 4510 746)
`2 41-6 10.651]
`
`I
`
`I
`
`I
`
`Dar 1!
`Blair 42
`Dar B-1
`
`.0 4810 798)
`-0 60 10.899)
`-0 T1 (0 9-13)
`
`.0 11811] 81321
`0.69 [1191 B1
`-0.?‘.‘1- [E9231
`
`-9 I210 [.13 11. D11]
`-11.0-91-0.22, U (34)
`-0.03 [-0 16, D10)
`
`rmiji
`-0.50
`000 025
`
`[Jay 14
`Day -12
`[Jay 8-!
`
`.0 M10 775)
`-0 6610 927)
`-0 6310.911)
`
`.0 4910 91-11
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`
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`
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`-050
`0130 D25
`
`[1] Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4.
`All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 2, one Vehicle treated subject who did not
`have a study eye designated was excluded from analysis.
`
`Reference ID: 3957400
`
`5
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`NDA 208073
`
`Page 10
`
`16
`
`HOW SUPPLIED/STORAGE AND HANDLING
`
`Xiidra (lifitegrast ophthalmic solution) 5% (50 mg/mL) is supplied in a foil pouch containing 5 low density
`polyethylene 0.2 mL single-use containers.
`
`NDC 54092-606-01; Carton of 60 single-use containers.
`
`Storage.‘
`Store at 20-25°C (68-77°F). Store single-use containers in the original foil pouch.
`
`17
`
`PATIENT COUNSELING INFORMATION
`
`Advise patients to read the FDA-approved patient labeling.
`
`Handling the Single-use Container
`Advise patients not to touch the tip of the single-use container to their eye or to any surface, in order to avoid eye
`injury or contamination of the solution.
`
`Use with Contact Lenses
`
`Advise patients that contact lenses, should be removed prior to administration of Xiidra and can be reinserted
`15 minutes after administration [see Dosage and Administration (2)].
`
`Administration
`
`Advise patients that the solution fiom one single-use container is to be used immediately after opening. It can be used
`to dose both eyes. The single-use container, including any remaining contents should be discarded immediately after
`administration [see Dosage and Administration (2)].
`
`Storage Information
`Instruct patients to store single-use containers in the original foil pouch until ready to use.
`
`Reference ID: 3957400
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`NDA 208073
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`Page 11
`
`What is Xiidra?
`
`Patient Information
`
`XiidraTM (ZYE-druh)
`(lifitegrast ophthalmic solution) 5%
`
`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
`0
`0 wear contact lenses
`
`0
`
`0
`
`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.
`
`0 Use Xiidra as your doctor tells you.
`
`0 Use 1 drop of Xiidra in each eye, 2 times each day, about 12 hours apart.
`
`0 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
`l-800-FDA-1088.
`
`How should I store Xiidra?
`
`0
`
`0
`
`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 from light.
`
`0 Do not open the Xiidra foil pouch until you are ready to use the eye drops.
`
`0 Return unused single-use containers to their original foil pouch to protect fiom excessive
`light exposure.
`
`Keep Xiidra and all medicines out of the reach of children.
`
`General information about the safe and effective use of Xiidra.
`
`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
`
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`NDA 208073
`
`Page 12
`
`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.
`
`Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421
`
`For more information, go to www.Xiidra.com or call 1-800-828-2088.
`
`This Patient Information has been approved by the U.S. Food and Drug Administration
`Issued: June 2016
`
`Reference ID: 3957400
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`NDA 208073
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`Page 13
`
`Instructions for Use
`
`XiidraTM (ZYE-druh)
`(lifitegrast ophthalmic solution) 5%
`for topical ophthalmic use
`
`Read this Instructions for Use before you start using XiidraTM 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:
`
`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 fiom 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 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.
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`

`NDA 208073
`
`Page 14
`
`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.
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`NDA 208073
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`Page 15
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`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
`our e e,
`n aain.
`
`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 our e es.
`
`Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.
`This Instructions for Use has been approved by the U.S. Food and Drug Administration
`Issued: 06/2016
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