Lifitegrast
Other Ophthalmologicals
Sold as XIIDRA
- 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
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.