Tyrvaya (nasal)

Varenicline nasal (for the nose) is used in adults to treat symptoms of dry eye disease. Varenicline nasal helps increase tear production in the eye after being sprayed into the nose.

Varenicline nasal may also be used for purposes not listed in this medication guide.

Use only as directed. Inform your doctor if you are taking any other medicines, have any other medical conditions, or have any allergies.

Tell your doctor if you have or have ever had health problems or are taking other medications.

It is not known if varenicline nasal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Common side effects of Tyrvaya may include:

• sneezing;
• cough; or
• irritation of the nose or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Varenicline nasal is for use in the nose.

Do not shake the bottle.

Varenicline nasal is usually sprayed once in each nostril twice per day (about 12 hours apart).

Read and carefully follow any Instructions for Use provided with your medicine. Be sure you understand how to properly prepare your first dose. Talk to your doctor or pharmacist if you do not understand these instructions or have any questions.

To use the nasal spray:

• Before your first use, prime it with 7 sprays into the air, away from your face.
• Tilt your head back slightly without lying down and insert the tip of bottle into the nostril. Breathe in and spray the medicine into your nose. Use in your other nostril as directed.
• If the spray gets in your eyes or mouth or on your skin, rinse with water.
• Clean the nasal applicator after each use.
• Prime again whenever the inhaler has not been used in longer than 5 days.
• Do not use the second bottle until you are done with the first bottle. Each bottle has about 15 days of treatment.

Store at room temperature away from moisture and heat. Do not freeze. Once opened, throw away the medicine after 30 days.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid priming varenicline (nasal) more than necessary. Priming will decrease the amount of medicine remaining in the bottle.

Other drugs may affect varenicline (nasal), including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.