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LFA-1 Integrin Antagonist — Dry Eye Disease Pregnancy: US labelling: there are no available data on use in pregnant women to inform any drug-associated risks. Intravenous lifitegrast in pregnant rats (premating through gestation day 17) did not produce teratogenicity at clinically relevant systemic exposures; in pregnant rabbits IV lifitegrast during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose, by AUC). Since human systemic exposure after ocular administration is low, the applicability of the animal findings to the risk in humans during pregnancy is unclear. Lactation: there are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant or on milk production; systemic exposure from ocular administration is low; the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the breastfed child.

Lifitegrast 5% Eye Drops

Brand names: Xiidra

Lifitegrast is a topical eye drop used to treat the signs and symptoms of dry eye disease.

Adult dose

Dose: Signs and symptoms of dry eye disease: 1 drop into each eye twice daily (approximately 12 hours apart)
Route: Topical ophthalmic (single-use container, into each eye)
Frequency: Twice daily, approximately 12 hours apart
Use the single-use container once and discard it immediately after using in each eye. Contact lenses should be removed prior to administration and may be reinserted 15 minutes following administration. Safety and efficacy in paediatric patients below the age of 17 years have not been established and no paediatric regimen is printed - for children use a children's formulary. No UK SPC for lifitegrast eye drops is listed on eMC — this dose is from US prescribing information (Xiidra, Novartis Pharmaceuticals Corporation) and must be verified against UK practice.

Dose adjustments

Renal

Not addressed in the US labelling retrieved for this page.

Hepatic

Not addressed in the US labelling retrieved for this page.

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation

Side effects

  • Instillation-site irritation, dysgeusia and reduced visual acuity (most common, 5% to 25% of patients)
  • Blurred vision, conjunctival hyperaemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis (1% to 5%)
  • Postmarketing: rare serious cases of hypersensitivity including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal oedema, swollen tongue, urticaria, allergic conjunctivitis, dyspnoea, angioedema and allergic dermatitis; eye swelling and rash

Monitoring

  • Watch for signs of hypersensitivity (including anaphylactic reaction, angioedema, bronchospasm) reported postmarketing

Clinical monograph

How it works

It is a lymphocyte function-associated antigen-1 (LFA-1) antagonist that blocks the interaction between LFA-1 and intercellular adhesion molecule-1, reducing T-cell-mediated inflammation on the ocular surface.

Prescribing in practice

  • Transient instillation site irritation, an altered or unusual taste (dysgeusia) and temporary reduced visual acuity are common and should be explained to patients to support adherence.
  • It is used on a regular twice-daily basis rather than as needed, so set expectations that benefit develops over weeks of continued use.
  • Remove contact lenses before instillation and reinsert after the recommended interval.

Monitoring

No systemic monitoring is required; review symptom and sign improvement and tolerability at clinical follow-up.

Counselling the patient

  • A temporary unusual taste and brief irritation or blurring after instillation are common and not a cause for concern.
  • Use it regularly twice daily as prescribed, remove contact lenses first, and reinsert them after the advised interval.

Evidence & guidelines

Lifitegrast is licensed for dry eye disease, with benefit on signs and symptoms demonstrated in randomised controlled trials.

Reference: MHRA Approval 2024 (Xiidra); FDA Approval 2016; Tauber et al. Ophthalmology 2015 (OPUS-1); Holland et al. Ophthalmology 2017 (OPUS-3); TFOS DEWS II 2017; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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