Lifitegrast: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: August 1, 2025🚩 Report this page

Lifitegrast

Other Ophthalmologicals

Sold as XIIDRA

CA Health Canada

Drug class: Other Ophthalmologicals
Availability: See label
Routes: Ophthalmic
Markets covered: 1
Products on record: 1

Overview

Lifitegrast is an active pharmaceutical ingredient in the Other Ophthalmologicals group (S01XA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	1	August 1, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised August 1, 2025[1]

17 Page 3 of 23 XIIDRA® Lifitegrast Ophthalmic Solution PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Ophthalmic Solution containing lifitegrast 5% (w/v).
For a complete listing see Dosage Forms Composition and Packaging Section INDICATIONS AND CLINICAL USE XIIDRA® (Lifitegrast) is indicated for the treatment of the signs and symptoms of dry eye disease. Geriatrics (> 65 years of age) No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Pediatrics (< 18 years of age) The safety and efficacy of XIIDRA have not been established in pediatric patients. CONTRAINDICATIONS Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph. Page 4 of 23 WARNINGS AND PRECAUTIONS Immune Hypersensitivity reactions are possible with XIIDRA. Rarely, allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with post marketing reports for XIIDRA.

Sources & citations

[1]Health Canada (DPD) · 02471027 · revised August 1, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised August 1, 2025[1]

Adverse Drug Reaction Overview The most common ocular adverse reactions were eye irritation (18%), eye pain (13%) and instillation site reactions (12%); the majority of ocular adverse reactions were mild and transient in nature. The most common non-ocular adverse reaction was dysgeusia (14%).
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In 5 clinical studies of dry eye disease, 1401 subjects received at least 1 dose of lifitegrast (1287 of which received lifitegrast ophthalmic solution 5%).
The majority of subjects (84%) had 3 months of treatment exposure. 177 subjects were exposed to lifitegrast for >6 months and 170 subjects were exposed to lifitegrast for approximately 12 months. The lifitegrast population was predominantly female (77%) and white (84%).
8) 1 Patients from safety population received at least one dose of study treatment during the study trial. Long-Term Study A long-term randomized, double-masked and placebo-controlled safety study was conducted over the course of 12 months in 332 patients (262 subjects completed) with dry eye disease.
Patients were allowed to use artificial tears concomitantly. The safety profile observed in this long-term study was similar to that seen in the short-term 12-week studies. Post-Market Adverse Reactions The following adverse reactions have been identified during post-approval use of XIIDRA.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions identified in post-marketing hypersensitivity reports included anaphylactic reaction, swollen tongue, hypersensitivity, Type IV hypersensitivity reaction, asthma, dyspnoea, pharyngeal edema, respiratory distress, angioedema, conjunctivitis allergic, and dermatitis allergic.
Page 7 of

CAOfficial regulatory label· Warnings and precautions· revised August 1, 2025[1]

Immune Hypersensitivity reactions are possible with XIIDRA. Rarely, allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with post marketing reports for XIIDRA. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
Driving and Operating Machinery XIIDRA may cause transient blurred vision at instillation. If patients experience blurred vision, they should be advised not to drive or operate machinery until their vision has cleared. Special Populations Pregnant Women There are no adequate and well-controlled studies of XIIDRA use in pregnant women.
In a reproductive toxicology study in rats, intravenous administration of lifitegrast from pre-mating through gestation day 17 resulted in an increase in incidence of pre-implantation loss and incidences of skeletal malformations. In a reproductive toxicity study in rabbits, intravenous administration of lifitegrast during organogenesis resulted in incidences of omphalocele.
Since human systemic exposure to lifitegrast following ocular administration at the recommended human ophthalmic dose (RHOD) is low, the applicability of animal findings to the risk of lifitegrast use in humans during pregnancy is unclear.
XIIDRA should be used with caution during pregnancy (see TOXICOLOGY, Reproductive and Developmental Toxicity). Nursing Women It is not known whether XIIDRA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XIIDRA is administered to a nursing woman.
Pediatrics The safety and efficacy of XIIDRA have not been established in pediatric patients. Geriatrics No overall differences in safety or effectiveness have been observed between elderly and younger patients. Page 5 of

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

Drugs in the same class

Sources & citations