Xiidra (lifitegrast)

The recommended dosage of lifitegrast in the management of dry eye disease in adults is 1 drop of a 5% ophthalmic solution in each eye twice daily, administered approximately 12 hours apart.

Lifitegrast is applied topically to the eye as an ophthalmic solution. The ophthalmic solution is for topical ophthalmic use only. Care should be taken to avoid eye injury or contamination of the solution container. The tip of the single-use container should not touch the eye or any other surface.

Contact lenses should be removed prior to administration of lifitegrast ophthalmic solution and may be reinserted 15 minutes after administration.

Single-use containers of lifitegrast ophthalmic solution should not be removed from the foil pouch until ready to use. After removing a single-use container from the foil pouch, the remaining containers should be placed back in the pouch and the edge should be folded to close the pouch.

There is a sufficient amount of lifitegrast ophthalmic solution in each single-use container for administration of 1 dose into each eye. The preservative-free solution is for single use only and any unused portion should be discarded immediately after administration.

No dosing information is available for this tab.

No formal drug interaction studies involving lifitegrast ophthalmic solution have been performed.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Manufacturer states none known.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse effects of lifitegrast ophthalmic solution (reported in 5-25% of patients) are instillation site irritation, dysgeusia, and reduced visual acuity. Other adverse effects (occurring in 1-5% of patients) include ocular effects such as blurred vision, conjunctival hyperemia, irritation, increased lacrimation, discharge, discomfort, and pruritus as well as nonocular effects such as headache and sinusitis.

Rare or Very Rare

• Acute respiratory distress syndrome
• Anaphylaxis
• Angioedema
• Bronchospastic pulmonary disease
• Dyspnea
• Pharyngeal edema
• Tongue swelling

More Frequent

• Dysgeusia
• Ocular irritation
• Reduced visual acuity

Less Frequent

• Blurred vision
• Conjunctival hyperemia
• Eye tearing
• Headache disorder
• Ocular discharge
• Ocular itching
• Ocular pain
• Sinusitis

Rare or Very Rare

• Periorbital edema
• Skin rash
• Urticaria

No enhanced messaging available.

Safety and efficacy of lifitegrast ophthalmic solution have not been established in pediatric patients younger than 17 years of age.

There are no data available regarding the use of lifitegrast ophthalmic solution in pregnant women. In pregnant rats, IV administration of lifitegrast did not result in teratogenic effects at relevant systemic exposures. In pregnant rabbits, IV administration of lifitegrast 3 mg/kg per day (400-fold human plasma exposures at the recommended ophthalmic dosage) increased incidence of omphalocele.

It is not known whether lifitegrast is distributed into human milk following topical application to the eye. There are no data available regarding lifitegrast effects on the breast-fed infant or milk production. Although systemic exposure to lifitegrast after ophthalmic administration is low, the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the infant from lifitegrast.

No overall differences in safety or efficacy have been observed between geriatric patients and younger adults.