Side Effects of Xiidra (lifitegrast) ophthalmic

Xiidra (lifitegrast ophthalmic solution) 5%, for topical ophthalmic use is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).

Common side effects of Xiidra include irritation or discomfort when the drops are applied to the eyes, changes in taste, blurred vision eye redness, headache, increased tearing, eye discharge, eye itching, and sinusitis.

Serious side effects of Xiidra include hypersensitivity (rare), including anaphylactic reaction, bronchospasm, respiratory distress, throat swelling, swollen tongue, hives, allergic conjunctivitis, shortness of breath, skin swelling, and allergic dermatitis.

There are no listed drug interactions of Xiidra.

There are no available data on Xiidra use in pregnant women to inform any drug associated risks. It is unknown if Xiidra will harm a fetus.

There are no data on the presence of Xiidra in breast milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lifitegrast from ocular administration is low. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra.

The most common side effects of Xiidra include eye irritation, discomfort, or blurred vision when the drops are applied to the eyes, and an unusual taste sensation (dysgeusia).

Seek medical care immediately if you get any symptoms of wheezing, difficulty breathing, or swollen tongue.

These are not all the possible side effects of Xiidra.

Tell your doctor if you have any side effects that bother you. You may report side effects to FDA at 1-800-FDA-1088.

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 each eye.

Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.

The following serious adverse reactions are described elsewhere in the labeling:

• Hypersensitivity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

• In five clinical trials of DED conducted with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received lifitegrast 5%).
• The majority of patients (84%) had less than or equal to 3 months of treatment exposure.
• One hundred-seventy patients were exposed to lifitegrast for approximately 12 months.
• The majority of the treated patients were female (77%).
• The most common adverse reactions reported in 5%-25% of patients were instillation-site irritation, dysgeusia, and reduced visual acuity.

Other adverse reactions reported in 1%-5% of the patients were

• blurred vision,
• conjunctival hyperemia,
• eye irritation,
• headache,
• increased lacrimation,
• eye discharge,
• eye discomfort,
• eye pruritus, and
• sinusitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Xiidra. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Rare serious cases of hypersensitivity, including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal edema, swollen tongue, urticaria, allergic conjunctivitis, dyspnea, angioedema, and allergic dermatitis have been reported. Eye swelling and rash have also been reported.