Indication:
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 USAGE
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).
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
15. Xiidra Lifitegrast Ophthalmic 7/11/2016
Solution
To treat the signs and symptoms of dry eye disease
Approved by FDA on 7/11/2016 (Ref- FDA approved List- 2016)
Press Release
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reactions (incidence 5-25%) following the use of
Xiidra were instillation site irritation, dysgeusia and decreased visual acuity.
Contra-Indications:
CONTRAINDICATIONS
None
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
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).
DOSAGE AND ADMINISTRATION
One drop twice daily in each eye (approximately 12 hours apart).
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing lifitegrast 5% (50 mg/mL).
Patient Information:
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
Administration
Advise patients that the solution from 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
Storage Information
Instruct patients to store single-use containers in the original foil pouch until ready to use.
Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
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.
The exact mechanism of action of lifitegrast in dry eye disease is not known.
2.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 from
0.55 ng/mL to 3.74 ng/mL.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Risk Summary 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,
from pre-mating through gestation day 17, did not produce teratogenicity at
clinically relevant systemic exposures
2. Lactation
Risk Summary There are no data on the presence of lifitegrast in human milk, the
effects on the breastfed infant, or the effects on milk production. However, systemic
exposure to lifitegrast from ocular administration is low
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 from Xiidra.
3 Pediatric Use
Safety and efficacy in pediatric patients below the age of 17 years have not been
established.
4. Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly
and younger adult patients.
Manufacturer Details