lifitegrast ophthalmic (Rx)

Brand and Other Names:Xiidra
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 5% (50mg/mL) in single-use containers

Dry Eye Disease

Indicated for treatment of the signs and symptoms of dry eye disease (DED)

Instill 1 gtt q12hr into each eye (also see Administration)

<17 years: Safety and efficacy not established

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Adverse Effects

>10%

Instillation site irritation (5-25%)

Dysgeusia (5-25%)

Reduced visual acuity (5-25%)

1-10%

Blurred vision (1-5%)

Conjunctival hyperemia (1-5%)

Eye irritation (1-5%)

Headache (1-5%)

Increased lacrimation (1-5%)

Eye discharge (1-5%)

Eye discomfort (1-5%)

Eye pruritus (1-5%)

Sinusitis (1-5%)

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Warnings

Contraindications

None

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Pregnancy

Pregnancy

There are no available data regarding use in pregnant women to inform any drug-associated risks

Animal data (IV administration)

  • Lifitegrast administered daily by IV injection to rats, from premating through gestation day 17, caused an increase in mean preimplantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the recommended human ophthalmic dose (RHOD)
  • In rabbits, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the RHOD, based on AUC), when administered by IV injection daily from gestation days 7 through 19

Lactation

There are no data on the presence of lifitegrast in human milk; systemic exposure to lifitegrast from ocular administration is low

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

The exact mechanism in dry eye disease is not known

Binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein bound on leukocytes, and blocks the interactions of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1)

ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease; LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues

In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells

Absorption

Systemic absorption is low following ophthalmic administration

19% of patients studied had plasma lifitegrast trough concentration >0.5 ng/mL (the lower limit of assay quantitation)

Trough plasma concentrations that could be quantitated ranged from 0.55-3.74 ng/mL

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Administration

Ophthalmic Administration

Drops are in single-use containers; discard the single-use container immediately after using in each eye

Remove contact lenses before instilling eye drops; may be reinserted 15 minutes following administration

Storage

Store at 20-25°C (68-77°F)

Store single-use containers in the original foil pouch

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.