Tyrvaya 0.03mg Nasal Spray
It is used to treat dry eyes.
Drug Class
Ophthalmic agent, Dry Eye Disease treatment
Pharmacologic Class
Nicotinic acetylcholine receptor agonist
Pregnancy Category
Not assigned (PLLR)
FDA Approved
Oct 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tyrvaya is a nasal spray that helps your eyes make more of their own natural tears. It works by stimulating a nerve pathway that tells your tear glands to produce more tears, helping to relieve the dryness and discomfort of dry eye disease.
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. When using the nasal spray, direct it up your nose only, avoiding contact with your eyes.
Before using the nasal spray for the first time, prime the pump by spraying it 7 times away from your face. If you haven't used the spray for 5 days, re-prime it by spraying once.
Important handling instructions:
Do not shake the nasal spray.
After each use, clean the spray tip with a clean tissue or cloth.
If the spray tip becomes clogged, follow the cleaning instructions provided or refer to the package insert.
Replace the cap after using your dose.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. After opening, discard any unused portion after 30 days.
Missed Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses to make up for the missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. When using the nasal spray, direct it up your nose only, avoiding contact with your eyes.
Before using the nasal spray for the first time, prime the pump by spraying it 7 times away from your face. If you haven't used the spray for 5 days, re-prime it by spraying once.
Important handling instructions:
Do not shake the nasal spray.
After each use, clean the spray tip with a clean tissue or cloth.
If the spray tip becomes clogged, follow the cleaning instructions provided or refer to the package insert.
Replace the cap after using your dose.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. After opening, discard any unused portion after 30 days.
Missed Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses to make up for the missed dose.
Lifestyle & Tips
- Use as directed, one spray in each nostril, twice a day, approximately 12 hours apart.
- Do not spray into the eyes.
- If you wear contact lenses, remove them before using Tyrvaya and wait at least 15 minutes before reinserting them.
- Avoid touching the tip of the spray bottle to your nose or any other surface to prevent contamination.
- Store at room temperature, away from light and moisture.
- Consider using humidifiers, avoiding direct air conditioning/heating vents, and taking breaks from screen time to help manage dry eye symptoms.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One spray (0.03 mg) into each nostril twice daily (approximately 12 hours apart)
Dose Range:
0.03 - 0.03 mg
Condition-Specific Dosing:
dry_eye_disease:
One spray (0.03 mg) into each nostril twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed, but caution is advised due to primary renal excretion
Dialysis:
Not specifically studied; caution advised due to primary renal excretion
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Varenicline is a highly selective nicotinic acetylcholine receptor (nAChR) agonist. For dry eye disease, it is believed to activate the trigeminal parasympathetic pathway, leading to increased basal tear film production. Specifically, it acts as an agonist at alpha7 and alpha4beta2 nAChRs.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for nasal administration, but systemic absorption occurs.
Tmax:
Approximately 10 minutes after nasal administration.
FoodEffect:
Not relevant for nasal spray administration.
Distribution:
Vd:
Not specifically reported for nasal varenicline; for oral varenicline, approximately 415 L.
ProteinBinding:
<20% (low protein binding).
CnssPenetration:
Yes (systemic absorption occurs, and varenicline is known to cross the blood-brain barrier).
Elimination:
HalfLife:
Approximately 24 hours (systemic).
Clearance:
Primarily renal clearance.
ExcretionRoute:
Renal excretion.
Unchanged:
>90% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Improvement in tear production can be observed within weeks of consistent use.
PeakEffect:
Sustained improvement in signs and symptoms of dry eye disease is typically observed over several weeks to months of treatment.
DurationOfAction:
Effects persist with continued twice-daily administration.
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:
- Sneezing
- Cough
- Nose or throat irritation
Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for 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:
- Sneezing
- Cough
- Nose or throat irritation
Important Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for 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:
- Severe or persistent nasal irritation, burning, or stinging
- Frequent or severe nosebleeds
- New or worsening vision changes
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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 this medication can be taken with all your current 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 this medication can be taken with all your current 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. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with Tyrvaya is unlikely due to the nasal route of administration and low systemic exposure. Symptoms of systemic varenicline overdose (from oral forms) could include nausea, vomiting, headache, dizziness, tremor, and unsteadiness.
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Ophthalmic examination (e.g., Schirmer's test, fluorescein staining)
Rationale: To assess baseline severity of dry eye disease and confirm diagnosis.
Timing: Prior to initiation of therapy
Assessment of dry eye symptoms (e.g., Ocular Surface Disease Index - OSDI)
Rationale: To quantify baseline symptom burden.
Timing: Prior to initiation of therapy
Routine Monitoring
Dry eye symptoms (e.g., discomfort, foreign body sensation, blurred vision)
Frequency: Periodically, as clinically indicated (e.g., every 1-3 months initially, then every 6-12 months)
Target: Reduction in symptom severity
Action Threshold: Lack of improvement or worsening symptoms may warrant re-evaluation of treatment.
Nasal and throat irritation
Frequency: Routinely, especially during initial treatment
Target: Tolerable level of irritation
Action Threshold: Severe or persistent irritation may require dose adjustment or discontinuation.
Symptom Monitoring
- Nasal irritation
- Sneezing
- Cough
- Throat irritation
- Nosebleeds (epistaxis)
- Changes in vision
- Eye discomfort or pain
Special Patient Groups
Pregnancy
Risk Summary: There are no adequate and well-controlled studies of Tyrvaya in pregnant women. Animal reproduction studies with varenicline administered orally showed no evidence of adverse developmental outcomes at clinically relevant exposures. Tyrvaya should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show no adverse effects at clinically relevant exposures.
Second Trimester:
Limited human data; animal studies show no adverse effects at clinically relevant exposures.
Third Trimester:
Limited human data; animal studies show no adverse effects at clinically relevant exposures.
Lactation
Risk Summary: Varenicline (oral) is excreted in human milk. It is not known whether Tyrvaya (nasal varenicline) is excreted in human milk. However, systemic exposure to varenicline following nasal administration is lower than with oral administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tyrvaya and any potential adverse effects on the breastfed infant from Tyrvaya or from the underlying maternal condition.
Infant Risk:
Low risk. Monitor breastfed infants for potential adverse reactions (e.g., irritability, changes in feeding or sleep patterns), though unlikely given low systemic exposure.
Pediatric Use
The safety and effectiveness of Tyrvaya in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects. No dose adjustment is necessary in elderly patients.
Clinical Information
Clinical Pearls
- Tyrvaya is the first and only nasal spray approved for the treatment of signs and symptoms of dry eye disease.
- It works by stimulating the trigeminal nerve in the nose, which then activates the parasympathetic nervous system to increase natural tear production.
- Patients should be instructed on proper nasal spray technique, ensuring the spray is administered into the nostril and not the eye.
- Common side effects are related to nasal administration, such as sneezing, cough, and nasal/throat irritation.
- Unlike many other dry eye treatments, Tyrvaya does not require direct application to the eye, which can be beneficial for patients with sensitive eyes or difficulty with eye drops.
Alternative Therapies
- Cyclosporine ophthalmic emulsion/solution (e.g., Restasis, Cequa)
- Lifitegrast ophthalmic solution (e.g., Xiidra)
- Topical corticosteroids (short-term use)
- Artificial tears/lubricating eye drops
- Punctal plugs
- Warm compresses
- Omega-3 fatty acid supplements
Cost & Coverage
Average Cost:
$600 - $800 per 30-day supply (2 bottles)
Insurance Coverage:
Tier 3 or higher (Specialty Drug)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may have additional patient information leaflets available; you can consult with your pharmacist to determine if this applies to your specific medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.