Xiidra 5% Ophth Sol Singles 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. This medication is for eye use only.
Preparation and Administration
1. Remove your contact lenses before using this medication. You can put them back in 15 minutes after administration, unless your eyes are irritated or infected.
2. Avoid touching the container tip to your eye, lid, or other skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
3. Wash your hands before and after using the medication.
4. Do not open the container until you are ready to use it. Use the medication immediately after opening.
5. Tilt your head back and gently drop the medication into your eye.
6. After administration, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Important Safety Information
Each container is for single use only. Use the medication right after opening and discard any remaining balance after administration.
Do not use the medication if the container has been opened previously.
Storage and Disposal
Store the medication at room temperature, protected from light. Keep unused containers in their original foil pouch until use.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for eye use only.
Preparation and Administration
1. Remove your contact lenses before using this medication. You can put them back in 15 minutes after administration, unless your eyes are irritated or infected.
2. Avoid touching the container tip to your eye, lid, or other skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
3. Wash your hands before and after using the medication.
4. Do not open the container until you are ready to use it. Use the medication immediately after opening.
5. Tilt your head back and gently drop the medication into your eye.
6. After administration, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Important Safety Information
Each container is for single use only. Use the medication right after opening and discard any remaining balance after administration.
Do not use the medication if the container has been opened previously.
Storage and Disposal
Store the medication at room temperature, protected from light. Keep unused containers in their original foil pouch until use.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Remove contact lenses before applying Xiidra and wait at least 15 minutes before reinserting them.
- 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 using other eye drops, wait at least 5 minutes between applications.
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:
dry_eye_disease:
One drop in each eye twice daily (approximately 12 hours apart)
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 dosage adjustment necessary; minimal systemic absorption
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 corneal and conjunctival tissues in 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 the subsequent T-cell activation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; plasma concentrations generally below the lower limit of quantification (0.5 ng/mL)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic solution)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not precisely quantifiable due to minimal systemic absorption; estimated terminal half-life of 24.1 to 37.4 hours based on limited data
Clearance:
Not precisely quantifiable
ExcretionRoute:
Primarily renal (as parent drug and metabolite) based on limited systemic exposure
Unchanged:
Not precisely quantifiable
Pharmacodynamics
OnsetOfAction:
Improvement in symptoms (e.g., eye dryness score) may be observed as early as 2 weeks, with continued improvement over 12 weeks.
PeakEffect:
Typically observed at 12 weeks of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; symptoms may recur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, 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 about side effects, contact your doctor. 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 or seek medical attention immediately, 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 about side effects, contact your doctor. 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:
- Eye irritation or discomfort that worsens or does not go away
- New or worsening eye pain
- Changes in vision
- Signs of eye infection (e.g., redness, swelling, discharge)
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. Do not initiate, discontinue, or modify the dosage 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. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision to ensure your safety. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely to occur with ophthalmic administration due to minimal systemic absorption.
What to Do:
If an overdose is suspected or if the solution is accidentally ingested, contact a poison control center or emergency medical services. Call 1-800-222-1222.
Drug Interactions
Monitoring
Routine Monitoring
Ocular signs and symptoms of dry eye disease (e.g., eye dryness score, fluorescein staining)
Frequency: Periodically, as clinically indicated (e.g., at follow-up visits)
Target: Improvement from baseline
Action Threshold: Lack of improvement or worsening of symptoms may indicate need for re-evaluation or alternative therapy.
Ocular adverse reactions (e.g., irritation, blurred vision)
Frequency: At each visit, or as reported by patient
Target: Absence or mild, tolerable reactions
Action Threshold: Persistent or severe reactions may warrant discontinuation.
Symptom Monitoring
- Eye dryness
- Eye irritation
- Blurred vision
- Dysgeusia (unusual taste sensation)
- Headache
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Xiidra in pregnant women. Animal studies showed no adverse developmental effects at clinically relevant exposures. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown; minimal systemic absorption suggests low risk.
Second Trimester:
Risk unknown; minimal systemic absorption suggests low risk.
Third Trimester:
Risk unknown; minimal systemic absorption suggests low risk.
Lactation
It is not known whether lifitegrast is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is expected to be low. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed infant from Xiidra or from the underlying maternal condition.
Infant Risk:
Low risk expected due to minimal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 17 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger adult patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Xiidra is a prescription eye drop specifically for dry eye disease, not just general eye dryness.
- Patients should be instructed on proper instillation technique to minimize contamination and maximize efficacy.
- The most common side effect is instillation site irritation and dysgeusia (unusual taste), which is often described as metallic or chemical. This is usually transient.
- Consistent, twice-daily use is important for optimal results, as the full therapeutic effect may take up to 12 weeks.
- Single-use vials are designed for one-time use and should be discarded immediately after use, even if solution remains, to prevent contamination.
Alternative Therapies
- Cyclosporine ophthalmic emulsion (Restasis, Cequa, Verkazia)
- Topical corticosteroids (short-term use for acute flares)
- Artificial tears/lubricating eye drops
- Punctal plugs
- Tear stimulants (e.g., diquafosol, rebamipide - not available in all regions)
- Oral omega-3 fatty acids (adjunctive therapy)
- Thermal pulsation/LipiFlow (for meibomian gland dysfunction)
Cost & Coverage
Average Cost:
$600 - $700 per 60 single-use vials (30-day supply)
Insurance Coverage:
Tier 2 or 3 (Specialty drug)
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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.