Dosing and uses of Xiidra (lifitegrast ophthalmic)
Adult dosage forms and strengths
ophthalmic solution
- 5% (50mg/mL) in single-use containers
Dry Eye Disease
Indicated for treatment of the signs and symptoms of dry eye disease (DED)
Instill 1 gtt q12hr into each eye (also see Administration)
Pediatric dosage forms and strengths
<17 years: Safety and efficacy not established
Xiidra (lifitegrast ophthalmic) adverse (side) effects
>10%
Instillation site irritation (5-25%)
Dysgeusia (5-25%)
Reduced visual acuity (5-25%)
1-10%
Blurred vision (1-5%)
Conjunctival hyperemia (1-5%)
Eye irritation (1-5%)
Headache (1-5%)
Increased lacrimation (1-5%)
Eye discharge (1-5%)
Eye discomfort (1-5%)
Eye pruritus (1-5%)
Sinusitis (1-5%)
Warnings
Contraindications
None
Pregnancy
Pregnancy
There are no available data regarding use in pregnant women to inform any drug-associated risks
Animal data (IV administration)
- Lifitegrast administered daily by IV injection to rats, from premating 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 recommended human ophthalmic dose (RHOD)
- In rabbits, 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 from gestation days 7 through 19
Lactation
There are no data on the presence of lifitegrast in human milk; systemic exposure to lifitegrast from ocular administration is low
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Xiidra (lifitegrast ophthalmic)
Mechanism of action
The exact mechanism in dry eye disease is not known
Binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein bound on leukocytes, and blocks the interactions 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
Absorption
Systemic absorption is low following ophthalmic administration
19% of patients studied had plasma lifitegrast trough concentration >0.5 ng/mL (the lower limit of assay quantitation)
Trough plasma concentrations that could be quantitated ranged from 0.55-3.74 ng/mL
Administration
Ophthalmic Administration
Drops are in single-use containers; discard the single-use container immediately after using in each eye
Remove contact lenses before instilling eye drops; may be reinserted 15 minutes following administration
Storage
Store at 20-25°C (68-77°F)
Store single-use containers in the original foil pouch
