TM Owner Bausch & Lomb Incorporated
Xiidra 5% Eye Drops
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Indications & Clinical Uses
- Xiidra 5% (lifitegrast ophthalmic solution) is a prescription eye drop for the treatment of the signs and symptoms of dry eye disease in adults; safety and efficacy have not been established in patients under 17 years.
- It is approved in the United States and is not authorised in the EU, because Novartis Europharm withdrew its EU application on 18 June 2020 after the European Medicines Agency judged the benefits did not outweigh the risks.
- The US label holder is now Bausch & Lomb (the product was previously held by Novartis).
- The dose is one drop in each eye twice daily, about 12 hours apart, from a single-use container supplied in foil pouches.
- It is used by the patient at home after instruction from a healthcare provider, and contact lenses must be removed before use.
Side Effects
- The most common side effects, occurring in 5% to 25% of patients, are instillation-site irritation (stinging or burning when the drop goes in), dysgeusia (an unusual or bitter taste) and decreased visual acuity (reduced or blurred vision).
- Reactions in 1% to 5% of patients include blurred vision, red eyes (conjunctival hyperaemia), eye irritation, headache, watering eyes, eye discharge, eye discomfort, eye itching and sinusitis.
- Rare serious reactions reported after approval include anaphylaxis, bronchospasm, difficulty breathing, throat swelling and angioedema (swelling of the face, lips or tongue); seek emergency help if these occur.
- The label carries no boxed warning.
- If the drop causes blurred vision, wait until your vision clears before driving.
Precautions & Warnings
- Xiidra must not be used by anyone allergic to lifitegrast or any ingredient.
- Remove contact lenses before putting in the drops and wait 15 minutes before reinserting them.
- Use one single-use container for both eyes, then throw it away; do not reuse it or keep it for later.
- Remove the container from its foil pouch only immediately before use, and keep unused containers in the original foil pouch at 20°C to 25°C.
- There are no data on use in pregnant women; rabbit studies showed increased omphalocele at the lowest doses tested, although body exposure from eye drops is minimal, so discuss pregnancy with your provider.
- Safety and efficacy in people under 17 years have not been established.
- Tell your provider if your eyes become painful, very red or your vision worsens.
Avoid Interactions
- The US prescribing information does not describe any drug interactions with Xiidra, and no medicines are listed that increase its effect or reduce its effectiveness.
- Because contact lenses can interfere with the drops, remove them before dosing and reinsert them 15 minutes afterwards.
- If you use other eye drops, tell your healthcare provider or pharmacist so they can advise on the order and spacing of use; do not mix drops in the same container.
- Tell your provider about all prescription and non-prescription medicines and supplements you take, including any other eye treatments.
References
Frequently Asked Questions
Xiidra (lifitegrast) eye drops treat the signs and symptoms of dry eye disease in adults. Safety and effectiveness have not been established in people under 17. It is approved in the United States but is not authorised in the EU.
Put one drop of Xiidra (lifitegrast) in each eye twice a day, about 12 hours apart. Take a single-use container from its foil pouch just before use, use it for both eyes, then throw it away. Do not reuse it.
Xiidra (lifitegrast) most often causes stinging or irritation when the drop goes in, an unusual taste, and reduced or blurred vision. Red, watery or itchy eyes and headache are less common. Get emergency help for swelling of the face or throat, or trouble breathing.
Remove contact lenses before using Xiidra (lifitegrast) and wait 15 minutes after the drops before putting them back in. Do not reuse the single-use container. The label lists no drug interactions, but tell your provider about any other eye drops you use.
Store Xiidra (lifitegrast) single-use containers at room temperature, 20°C to 25°C, in the original foil pouch until you are ready to use them. Discard each container after dosing both eyes, and do not keep opened containers for later use or reuse.
There are no data on Xiidra (lifitegrast) use in pregnant women, so discuss it with your provider first. Rabbit studies showed a birth defect at the lowest doses tested, although eye drops give minimal body exposure. It is not established for anyone under 17.
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