Xiidra

Indications for Use

Xiidra is specifically approved for the treatment of dry eye disease (DED). This condition occurs when the eyes do not produce enough tears or when the tears evaporate too quickly, which can lead to inflammation and discomfort on the surface of the eye.

The medication is designed to address both the signs of the condition that a healthcare provider can observe and the symptoms that a patient experiences. It is intended for daily, long-term use to manage chronic symptoms.

Common Symptoms Addressed

Patients with dry eye disease may be prescribed Xiidra to help relieve various symptoms, including:

• A persistent feeling of dryness or scratchiness
• Eye irritation, stinging, or burning
• Redness of the eyes
• A gritty sensation, often described as feeling like there is sand or a foreign object in the eye

Xiidra is used in adults to help improve eye comfort and manage the underlying inflammation associated with dry eye disease.

How Xiidra Works

Xiidra belongs to a class of medications called lymphocyte function-associated antigen-1 (LFA-1) antagonists. It is specifically designed to treat the signs and symptoms of dry eye disease by targeting inflammation on the surface of the eye.

The medication works by interfering with the interaction between two specific proteins:

• LFA-1: A protein found on the surface of white blood cells (lymphocytes).
• ICAM-1: A protein that is often found in higher amounts in the eye tissues of people with dry eye disease.

When these two proteins interact, they contribute to an inflammatory cycle that leads to the symptoms of dry eye, such as stinging, burning, or redness. Xiidra binds to LFA-1, which prevents it from connecting with ICAM-1. By blocking this interaction, the medication helps to reduce inflammation and improve the health of the eye surface.

Although the exact mechanism is not fully established, researchers believe that by inhibiting this protein interaction, Xiidra prevents inflammatory cells from sticking to the eye tissue and releasing chemicals that cause further irritation.

Common Side Effects

Most side effects from Xiidra are mild and typically affect the eyes or the sense of taste. Common symptoms include:

• Eye irritation: Stinging, burning, or a gritty feeling when the drops are applied.
• Taste changes: An unusual or metallic taste in the mouth (dysgeusia).
• Blurred vision: This is typically temporary and occurs immediately after use.
• Eye redness and itching: General discomfort or redness in the eye area.
• Watery eyes: Increased tearing.
• Headache: Some users report mild headaches.

Serious Side Effects

Contact a healthcare professional immediately if you experience signs of a severe reaction, including:

• Allergic reactions: Hives, rash, or swelling of the face, lips, tongue, or throat.
• Breathing difficulties: Shortness of breath or wheezing.
• Severe eye pain: Intense discomfort or significant swelling of the eye or eyelid.
• Persistent vision changes: Any changes in sight that do not resolve quickly.

Allergic Reactions

Some people using Xiidra have experienced serious hypersensitivity reactions. These may include anaphylaxis, swelling of the face, tongue, or throat (angioedema), difficulty breathing (bronchospasm), and skin rashes or hives. If these symptoms occur, medical attention should be sought immediately.

Eye Safety and Contamination

To avoid eye injury or contamination of the solution, the tip of the single-use container should not touch the eye, eyelids, or any other surface. Each container is intended for a single use only and should be discarded immediately after treating both eyes.

Contact Lens Use

Xiidra should not be administered while wearing contact lenses. Lenses should be removed before using the drops. It is recommended to wait at least 15 minutes after application before reinserting contact lenses.

Pregnancy and Breastfeeding

There is limited information regarding the safety of Xiidra use during pregnancy or while breastfeeding. The potential risks and benefits should be discussed with a healthcare professional.

Pregnancy

It is currently unknown if Xiidra (lifitegrast) can cause harm to an unborn baby. There have not been enough well-controlled studies in humans to determine the specific risks of using this medication during pregnancy.

In animal studies, no significant harm was observed in the offspring of animals given lifitegrast at doses much higher than the standard human dose. However, animal studies do not always predict how a human will respond. If you are pregnant or planning to become pregnant, discuss the potential benefits and risks with your healthcare provider.

Breastfeeding

It is not known whether lifitegrast passes into human breast milk or if it could affect a nursing infant. Because many drugs are excreted in human milk, caution is advised when using this medication while nursing.

When considering the use of Xiidra while breastfeeding, you and your doctor should evaluate:

• The mother's clinical need for the medication.
• The health and developmental benefits of breastfeeding for the child.
• Any potential adverse effects on the breastfed child from the drug.

Dosage Forms

Xiidra (lifitegrast) is available as a sterile ophthalmic solution. It is supplied in a 5% concentration.

Packaging Information

The medication is provided in individual, single-use containers. Key details regarding its packaging include:

• Single-use containers: Each container holds enough liquid for one dose (one drop in each eye).
• Foil pouches: The containers are stored inside foil pouches to protect the solution from light.
• Disposal: Because the containers do not contain preservatives, any leftover solution must be discarded immediately after a single use.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Xiidra (lifitegrast ophthalmic solution) 5% in July 2016. It is indicated for the treatment of both the signs and symptoms of dry eye disease in adult patients.

Regulatory History and Safety Monitoring

Xiidra was the first drug in a new class of medications known as lymphocyte function-associated antigen-1 (LFA-1) antagonists to receive FDA approval. Since its initial approval, the FDA has continued to monitor its safety profile through the FDA Adverse Event Reporting System (FAERS).

In 2020, the FDA evaluated a potential safety signal regarding reduced visual acuity associated with the use of Xiidra. After a thorough review of available data, the FDA concluded that no regulatory action was necessary at that time, though the agency continues to monitor the medication for new safety information.

Boxed Warnings and Restrictions

Xiidra does not currently carry any FDA boxed warnings, which are the most serious warnings issued by the agency. There is no Risk Evaluation and Mitigation Strategy (REMS) required for this medication, and it is not classified as a controlled substance.

Factors Affecting Cost

The price you pay for Xiidra can vary significantly based on several factors:

• Insurance Coverage: Most commercial insurance plans cover Xiidra, but your specific copay or coinsurance will depend on your plan's formulary. Medicare and Medicaid coverage may also vary.
• Pharmacy Choice: Prices can differ between retail pharmacies, mail-order services, and specialty pharmacies.
• Generic Availability: Currently, there is no generic version of lifitegrast available. Brand-name medications typically cost more than generics.

Financial Assistance

Patients may be able to reduce their out-of-pocket expenses through various programs:

• Manufacturer Savings Cards: The drug manufacturer often provides savings cards for patients with commercial insurance that can lower copays to a specific amount.
• Patient Assistance Programs: Some programs offer the medication at low or no cost to individuals who meet specific income requirements and do not have insurance coverage.

It is recommended to check with your insurance provider and pharmacist to determine the exact cost for your prescription.