Tyrvaya
Pronunciation: Teer-vye-ah
Generic name: varenicline solution
Dosage form: nasal spray (0.03 mg per spray)
Drug class: Cholinergic agonists
What is Tyrvaya?
Tyrvaya nasal spray is used to treat dry eye disease. Tyrvaya increases natural tear production by activating the trigeminal nerves within the nose to relieve dry eye symptoms.
Dry eye disease is often a long-term condition where there are problems with the tear film that normally protects and lubricated the eyes. Dry eye disease causes symptoms of stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue, and it may lead to inflammation and damage to the cornea. Natural tears are a complex mixture of proteins, growth factors, and antibodies. Tyrvaya is used to increase the amount of natural tear film to improve the symptoms of dry eye.
Tyrvaya (varenicline solution) is a highly selective cholinergic agonist (mode of action). Tyrvaya became an FDA-approved medicine on Oct. 18, 2021.
How effective is Tyrvaya?
Tyrvaya improved the Eye Dryness Score by -13.9 mm more than the placebo, which means that it was statistically significantly better at improving dry eyes than the placebo.
The clinical trial called ONSET-1 (NCT03636061) studied the effectiveness of Tyrvaya for dry eye. The study found that patients who used the 0.03 mg nasal spray twice daily for 28 days had a statistically significant improvement in tear film production when compared to the placebo group. The effectiveness was measured by the mean change from baseline in Eye Dryness Score. The higher the EDS score, the dryer the eyes. If the score decreases during treatment, then the eyes are less dry and more lubricated.
The results of ONSET-1 clinical trial show the mean change from baseline in Eye Dryness Score (EDS) at week 4:
- Tyrvaya-treated patients -18.9 mm
- placebo-treated patients -5.4 mm
- Difference between Tyrvaya patients and placebo patients was - 13.9 mm
Tyrvaya side effects
Common Tyrvaya side effects may include sneezing (82%), cough (16%), throat (13%), and nose irritation (8%). Most side effects reported were mild, and less than 2% of patients stopped treatment in clinical trials due to side effects.
These are not the only possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before using this medicine
Before using this medicine tell your doctor or prescriber about your medical conditions.
Pregnancy
Tell your healthcare provider if you are pregnant, planning a pregnancy, or become pregnant. It is not known if Tyrvaya will harm your unborn baby.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or are planning to breastfeed. It is not known if Tyrvaya passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.
How should I use Tyrvaya?
- Use the nasal spray exactly as your healthcare provider tells you to use it.
- Tyrvaya is a nasal spray that is sprayed into the nose.
- Do not shake the bottles.
- Spray one spray into each nostril two times daily (about 12 hours apart).
- Two nasal spray bottles are a one-month supply. You should finish the first bottle before opening the next bottle.
Dosing information
Usual Nasal Spray dose:
Use one spray in each nostril twice daily (approximately 12 hours apart).
Related/similar drugs
cyclosporine ophthalmic, varenicline, Restasis, Xiidra, Artificial Tears, Systane
What happens if I miss a dose?
If you miss a dose, skip that dose and take your next dose at your regular scheduled time. Do not take an extra dose to make up for a missed dose.
What other drugs will affect Tyrvaya?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Storage
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze.
- Discard Tyrvaya nasal spray bottle 30 days after first use.
Ingredients
Active ingredient: varenicline tartrate
Inactive ingredients: sodium phosphate dibasic heptahydrate, monobasic sodium phosphate, anhydrous, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.
Company
Manufactured for:
Oyster Point Pharma, Inc., 202 Carnegie Center, Suite 109, Princeton, NJ 08540.
Instructions for Use
Read this Instructions for Use before you start using Tyrvaya and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Steps for priming nasal spray before first use
Step 1. Remove the cap and the clip. Do not throw away the cap or the clip. The cap and the clip will be placed back on to the nasal applicator after each use.
Step 2. Hold the nasal spray bottle upright and away from your face. Place 1 finger on each side of the base of the nasal applicator and place your thumb underneath the bottle.
Step 3. Prime the nasal spray bottle by pressing and releasing the nasal applicator 7 times with your thumb and fingers. You may not see a spray released each time you press and release the nasal applicator. Spray away from yourself and others.
The nasal spray is now primed for use.
- Reprime: If you do not use the nasal for more than 5 days, you will need to reprime the nasal spray bottle with 1 spray before you start using it. To reprime, hold the nasal spray bottle upright and away from your face and press and release the nasal spray applicator 1 time.
- Avoid priming the nasal spray bottle more than needed: Priming the nasal spray bottle more than needed will reduce the amount of medicine in the nasal spray bottle.
Steps for using the nasal spray after priming
Step 1. Blow your nose to clear your nostrils, if needed.
Step 2. Remove the cap and clip. Do not throw away the cap or the clip. The cap and the clip will be placed back on to the nasal applicator after each use.
Step 3. Hold the nasal spray bottle upright. Place 1 finger on each side of the base of the nasal applicator and your thumb underneath the bottle.
Step 4. Tilt your head back slightly without lying down.
Step 5. Insert the nasal applicator into the left or right nostril. Tilt the nasal applicator and point the tip of the nasal applicator towards the top of the ear on the same side as your nostril.
Do not press the tip of the nasal applicator against the wall of the inside of your nose. Leave a space between the tip of the nasal applicator and the wall of the inside of your nose.
Step 6. Place your tongue to the roof of your mouth and breathe gently while pressing and releasing the nasal applicator 1-time to release a spray into your nostril.
Repeat Steps 5 and 6 to deliver a second spray in the other nostril.
Step 7. Wipe the nasal applicator with a clean tissue.
Step 8. Replace the clip and the cap.
Repeat Steps 1 to 8 each time you use the nasal spray.
Popular FAQ
How often can you use Tyrvaya?
Tyrvaya should be sprayed into each nostril twice a day (about every 12 hours) to treat the signs and symptoms of dry eye disease. Follow the special Instructions for Use included with your prescription to learn how to correctly spray Tyrvaya, or ask your healthcare provider.
How quickly does Tyrvaya work?
When used twice a day in each nostril, Tyrvaya nasal spray may start working as quickly as the first week to increase eye tear film production. In clinical studies, Tyrvaya increased tear production and relief of symptoms at 4 weeks, on average, in mild to severe dry eye disease.
Can you use Tyrvaya long term?
The recommended dose is one spray in each nostril twice daily (about every 12 hours). Only change your dose or stop treatment if directed by your doctor. Tyrvaya is a prescription nasal spray used to treat symptoms of dry eye disease.
What is the mechanism of action of Tyrvaya?
Tyrvaya works by activating a pathway in the nose that is responsible for your own natural tear production. It is thought to work as an agonist by binding to the nicotinic acetylcholine (nACh) receptor. This binding activates the trigeminal parasympathetic pathway in the nose to increase basal tear production. Continue reading
How long does a bottle of Tyrvaya last?
A bottle of Tyrvaya will last 15 days. This is because it contains 60 sprays and the recommended dose is ONE spray into BOTH nostrils Twice daily. This means you will use 4 sprays per day in total which will last 15 days. Each prescription of Tyrvaya comes with 2 glass nasal spray bottles which will last you 30 days in total. Continue reading
Does Tyrvaya reduce inflammation?
Tyrvaya does not reduce inflammation, it targets the trigeminal parasympathetic pathway which stimulates the lacrimal functional unit – an integrated system consisting of the lacrimal glands, surface of the eye, goblet glands and meibomian glands, and the nerves that connect them – to improve the quality and quantity of tear film produced. The trigeminal parasympathetic pathway is accessible through the nose, which is why Tyrvaya is produced as a nasal spray. This allows effective treatment of dry eye without the burning and stinging often associated with eye drops. Continue reading
References
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