Xiidra 5% Ophth Sol Singles 12 X 5s
It is used to treat dry eyes.
Drug Class
Ophthalmic anti-inflammatory
Pharmacologic Class
Lymphocyte function-associated antigen-1 (LFA-1) antagonist
Pregnancy Category
Not available
FDA Approved
Jul 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xiidra is an eye drop used to treat the signs and symptoms of dry eye disease. It works by reducing inflammation on the surface of your eyes that can cause dryness and discomfort.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication as directed.
Administration
This medication is for eye use only.
Before using, remove your contact lenses. You can put them back in 15 minutes after administering the medication, unless your eyes are irritated or infected.
To avoid contamination, do not touch the container tip to your eye, lid, or surrounding skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
Wash your hands thoroughly before and after using the medication.
Do not open the container until you are ready to use it, and use it immediately after opening.
Tilt your head back and gently drop the medication into your eye.
After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Important Usage Guidelines
Each container is for single use only. Use it immediately after opening and discard any remaining medication after administration.
Do not use the medication if the container has been previously opened or tampered with.
Storage and Disposal
Store the medication at room temperature.
Keep unused containers in their original foil pouches to protect them from light.
Dispose of any opened containers and unused medication according to your doctor's instructions or local regulations.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not use two doses at the same time or take extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication as directed.
Administration
This medication is for eye use only.
Before using, remove your contact lenses. You can put them back in 15 minutes after administering the medication, unless your eyes are irritated or infected.
To avoid contamination, do not touch the container tip to your eye, lid, or surrounding skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
Wash your hands thoroughly before and after using the medication.
Do not open the container until you are ready to use it, and use it immediately after opening.
Tilt your head back and gently drop the medication into your eye.
After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Important Usage Guidelines
Each container is for single use only. Use it immediately after opening and discard any remaining medication after administration.
Do not use the medication if the container has been previously opened or tampered with.
Storage and Disposal
Store the medication at room temperature.
Keep unused containers in their original foil pouches to protect them from light.
Dispose of any opened containers and unused medication according to your doctor's instructions or local regulations.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not use two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Remove contact lenses before applying Xiidra and wait at least 15 minutes after instilling the drops before reinserting contact lenses.
- Do not touch the tip of the single-use container to your eye or any other surface to avoid contamination.
- Use one single-use container for each eye, then discard immediately after use, even if there is solution remaining.
- If you are using other eye drops, wait at least 5 minutes between applying Xiidra and other eye medications.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in each eye twice daily (approximately 12 hours apart)
Condition-Specific Dosing:
dryEyeDisease:
One drop in each eye twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established in pediatric patients under 17 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No specific recommendations; systemic exposure is minimal.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Pharmacology
Mechanism of Action
Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist. It binds to LFA-1, a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand, intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in the corneal and conjunctival tissues of patients with 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 showed that lifitegrast inhibited the adhesion of T-cells to ICAM-1 and blocked T-cell activation.
Pharmacokinetics
Absorption:
Bioavailability:
Very low systemic absorption (plasma concentrations generally below the lower limit of quantification of 0.5 ng/mL)
Tmax:
Variable, typically 15 minutes to 12 hours post-dose (for detectable levels)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not available (due to minimal systemic absorption)
ProteinBinding:
Not available (due to minimal systemic absorption)
CnssPenetration:
Limited (not expected to penetrate CNS significantly due to low systemic exposure)
Elimination:
HalfLife:
Not precisely quantifiable due to low systemic levels; estimated terminal half-life of 24.5 hours for detectable levels.
Clearance:
Not precisely quantifiable due to low systemic levels.
ExcretionRoute:
Primarily renal (for the small amount absorbed systemically)
Unchanged:
Not available (due to minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement in symptoms (e.g., eye dryness score) observed as early as 2 weeks, with continued improvement up to 12 weeks.
PeakEffect:
Typically observed around 6-12 weeks of continuous use.
DurationOfAction:
Maintained with continued twice-daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Eye irritation
- Change in taste
- Blurred eyesight
Additional Information on Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Eye irritation
- Change in taste
- Blurred eyesight
Additional Information on Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Persistent or worsening eye irritation or pain
- Changes in vision
- Signs of eye infection (e.g., redness, discharge, swelling)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when operating a vehicle or performing tasks that require clear vision to ensure your safety. If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor promptly. Your doctor will need to discuss the potential benefits and risks of this medication with you, considering both your health and the well-being of your baby, to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Not expected to cause systemic toxicity due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If an overdose is suspected, contact a poison control center (1-800-222-1222) or seek medical attention. Management is generally supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Ophthalmic examination (e.g., corneal staining, conjunctival hyperemia)
Rationale: To assess baseline severity of dry eye disease.
Timing: Prior to initiation of therapy
Patient-reported symptoms (e.g., eye dryness score, discomfort)
Rationale: To establish baseline symptom severity and track improvement.
Timing: Prior to initiation of therapy
Routine Monitoring
Patient-reported symptoms (e.g., eye dryness score, discomfort)
Frequency: Periodically, as clinically indicated (e.g., at follow-up visits)
Target: Reduction in severity
Action Threshold: Lack of improvement or worsening symptoms may warrant re-evaluation of therapy.
Ophthalmic examination
Frequency: Periodically, as clinically indicated
Target: Improvement in objective signs (e.g., reduced corneal staining, reduced conjunctival hyperemia)
Action Threshold: Lack of improvement or worsening signs may warrant re-evaluation of therapy.
Symptom Monitoring
- Eye irritation
- Dysgeusia (altered taste sensation)
- Blurred vision (temporary)
- Conjunctival hyperemia
- Headache
- Discomfort upon instillation
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Xiidra in pregnant women. Animal studies did not show adverse developmental effects at clinically relevant systemic exposures. Given the minimal systemic absorption of lifitegrast following ophthalmic administration, maternal use is not expected to result in fetal exposure to the drug.
Trimester-Specific Risks:
First Trimester:
Low risk expected due to minimal systemic absorption.
Second Trimester:
Low risk expected due to minimal systemic absorption.
Third Trimester:
Low risk expected due to minimal systemic absorption.
Lactation
It is not known whether lifitegrast is excreted in human milk. However, systemic exposure to lifitegrast is negligible following ophthalmic administration, and therefore, breastfed infants are not expected to be exposed to the drug. 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 or from the underlying maternal condition.
Infant Risk:
Low risk expected due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients below 17 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. No dosage adjustment is necessary for geriatric patients.
Clinical Information
Clinical Pearls
- Patients may experience dysgeusia (altered taste sensation) as a common side effect, which is usually mild and transient.
- Temporary blurred vision may occur immediately after instillation; advise patients to wait until vision clears before driving or operating machinery.
- Xiidra is supplied in single-use containers; patients should be instructed to discard the container immediately after use, even if solution remains.
- It is important to emphasize consistent twice-daily dosing for optimal therapeutic effect, as clinical benefits may take several weeks to become apparent.
- Advise patients to avoid touching the tip of the single-use container to the eye or any other surface to prevent contamination.
Alternative Therapies
- Cyclosporine ophthalmic solution (e.g., Restasis, Cequa)
- Topical corticosteroids (for short-term use in severe inflammation)
- Artificial tears/lubricating eye drops
- Punctal plugs
- Oral secretagogues (e.g., pilocarpine, cevimeline - for Sjogren's related dry eye)
Cost & Coverage
Average Cost:
Typically high, ranging from $600-$800+ per 60 single-use vials (30-day supply)
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization, step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.