What is Tyrvaya?
Tyrvaya is a prescription nasal spray used to treat the signs and symptoms of dry eye disease.
What should I tell my healthcare provider before using Tyrvaya?
Before you use Tyrvaya, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if Tyrvaya will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Tyrvaya passes into your breast milk. You and your healthcare provider should decide if you will use Tyrvaya if you plan to breastfeed.
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.
How should I use Tyrvaya?
- See the Instructions for Use at the end of this Patient Information leaflet for information about the right way to use Tyrvaya.
- Tyrvaya increases tear production in the eye after being sprayed in the nose.
- Use Tyrvaya exactly as your healthcare provider tells you to use it.
- Do not shake the bottles.
- Spray Tyrvaya 1 time in each nostril, 2 times daily (about 12 hours apart).
- A 1-month supply of Tyrvaya consists of 2 nasal spray bottles. Finish 1 bottle before opening the second. Tyrvaya comes in glass bottles with a white nasal pump and blue dust cover.
- If you miss a dose of Tyrvaya, 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 are the possible side effects of Tyrvaya?
The most common side effects of Tyrvaya include sneezing, cough, and throat and nose irritation.
These are not the only possible side effects of Tyrvaya. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Tyrvaya
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tyrvaya for a condition for which it was not prescribed. Do not give Tyrvaya to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Tyrvaya that is written for health professionals.
How should I store Tyrvaya?
- Store Tyrvaya at room temperature between 68°F to 77°F (20°C to 25°C)
- Do not freeze.
- Throw away (discard) Tyrvaya nasal spray bottle 30 days after first use.
Keep Tyrvaya and all medicines out of the reach of children.
What are the ingredients in Tyrvaya?
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.
Instructions for use for Tyrvaya
Tyrvaya (Teer-vye-ah)
(varenicline solution)
nasal spray, for intranasal 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.
Important information you need to know before using Tyrvaya:
- Tyrvaya is for use in the nose.
- Do not shake the bottles.
- The Tyrvaya carton contains enough medicine for 30 days.
- Each carton has 2 glass nasal spray bottles.
- Each nasal spray bottle has enough medicine for 15 days of treatment.
- Do not open the second nasal spray bottle until you have used the entire first bottle.
Parts of your Tyrvaya nasal spray:
Steps for priming Tyrvaya 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.
Tyrvaya is now primed for use.
- Reprime: If you do not use Tyrvaya 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 Tyrvaya 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 Tyrvaya.
Instructions for use issued 10/2021