IMPORTANT SAFETY INFORMATION
ABOUT XIIDRA^®

Indications and clinical use:

XIIDRA^® is indicated for the treatment of the signs and symptoms of dry eye disease.

Contraindications:

Patients who are hypersensitive to this drug or to any ingredients in the formulation or component of the container should avoid taking XIIDRA^®. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph.

Relevant Warnings and PrecautionsImmune

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.

Use in Specific Populations:

• Pregnancy: There are no adequate and well-controlled studies of XIIDRA^® use in pregnant women. XIIDRA^® should be used with caution during pregnancy.
• Lactation: 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.
• Pediatric Use: Safety and efficacy in pediatric patients have not been established.
• Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions:

In clinical trials, 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%).

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 both eyes. Contact lenses should be removed prior to the administration of XIIDRA^® and may be reinserted 15 minutes following administration.

For more information:

Consult the complete Product Monograph at https://www.xiidra.ca/wpcontent/uploads/2024/01/xiidra_scrip_e.pdf for further information on contraindications, warnings, precautions, adverse reactions, and dosage and administration. The Product Monograph is also available at: 1-888-459-5000.