Tyrvaya (Varenicline Solution)
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Fact Table
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| Formula | C13H13N3 · C4H6O6 (varenicline tartrate) |
| License | U.S. FDA approved for dry eye disease (NDA 213978; 2021) |
| Bioavailability | Not formally stated; systemic exposure after 0.12 mg intranasal dose was ~7.5% of exposure after 1 mg oral varenicline |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3-h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1) |
| Elimination half-life | ~19 ± 10 hours after intranasal administration |
| Dosage (Strength) | 0.03 mg varenicline per 0.05 mL spray; 1 spray in each nostril twice daily (~12 hours apart) |
| Pregnancy | No available human data; animal studies did not show malformations at clinically relevant doses |
| Brands | Tyrvaya (Oyster Point Pharma; Viatris) |
| Protein binding | Low; =20% |
| PubChem CID | 9906942 (varenicline tartrate); 5310966 (varenicline) |
| MedlinePlus | a621057 |
| ChEBI | 84507 (varenicline tartrate); 84500 (varenicline) |
| ATC code | S01XA28; N07BA03 |
| DrugBank | DB01273; DBSALT000548 |
| KEGG | D06282 (varenicline tartrate); D08669 (varenicline) |
| Routes of administration | Intranasal; nasal spray |
Tyrvaya (varenicline) is a prescription nasal spray used to treat dry eye disease. Instead of applying medication directly to the eye like traditional eye drops, it works through the nose. It stimulates specific nerve pathways that signal the eyes to produce their own natural tears. Tyrvaya has been shown to significantly reduce dry eye symptoms.
Directions
Tyrvaya nasal spray is administered as one spray in each nostril twice daily, around 12 hours apart. Before using it for the first time, the bottle needs to be primed by actuating it seven times. If the spray has not been used for more than five days, re-prime it with one actuation before use. If a dose is missed, skip it and resume dosing at the next scheduled time. Do not use more than directed.
Ingredients
The active ingredient in Tyrvaya is varenicline tartrate 0.03 mg per spray (0.05 mL). Inactive ingredients include sodium phosphate dibasic heptahydrate, monobasic sodium phosphate anhydrous, sodium chloride, sodium hydroxide and/or hydrochloric acid (for pH adjustment), and water for injection.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Safety and effectiveness of Tyrvaya have not been established in children.
There are no available data on the use of Tyrvaya in pregnant women. Animal reproduction studies did not show evidence of malformations at doses for human use, though toxicity to an unborn baby may occur at high doses.
It is not known whether varenicline is present in human breast milk. The potential risks and benefits should be weighed when deciding whether to use Tyrvaya while breastfeeding.
No overall differences in safety or effectiveness have been observed between older and younger adult patients.
Contraindications
There are no contraindications for Tyrvaya listed in the drug label.
Side Effects
Common side effects of Tyrvaya include:
- Sneezing
- Cough
- Throat irritation
- Nose irritation
These effects are generally related to administering the drug through the nose. If side effects are persistent or bothersome, consult a healthcare provider.
Frequently Asked Questions about Tyrvaya
What is Tyrvaya used for?
Tyrvaya is a prescription nasal spray used to treat the signs and symptoms of dry eye disease.
How does Tyrvaya work?
It is believed to act on nicotinic acetylcholine receptors and activate the trigeminal parasympathetic pathway, which increases basal tear film production. The label also notes that the exact mechanism is not fully known.
How do you use Tyrvaya?
The usual dose is 1 spray in each nostril twice daily, about 12 hours apart. It is for use in the nose, not the eyes. Before first use, prime the bottle with 7 sprays into the air; if it has not been used for more than 5 days, re-prime with 1 spray. Do not shake the bottle.
How quickly can Tyrvaya start working?
In the manufacturer’s clinical-trial summary, Tyrvaya increased tear production on average as early as about 5 minutes after one dose. In trials, dryness symptoms improved at 4 weeks and as early as 3 weeks in 1 of the 2 studies, although individual results vary.
What are the most common side effects?
The most commonly reported side effects are sneezing, cough, throat irritation, and nose irritation. Sneezing was the most frequent reaction in trials, and the manufacturer reports that most side effects were mild, with no serious Tyrvaya-related side effects reported in those clinical trials.
What should you do if you miss a dose?
Skip the missed dose and take the next dose at the regular scheduled time. Do not use an extra dose to make up for the missed one.
Are there any major warnings or people who should avoid it?
The current prescribing information lists no contraindications. Even so, patients should tell their healthcare provider about all medical conditions and all medicines, vitamins, and herbal supplements before starting Tyrvaya.
Can Tyrvaya be used during pregnancy or breastfeeding?
There are no adequate human data to define drug-related risk in pregnancy, and it is not known whether Tyrvaya will harm an unborn baby. For breastfeeding, there are no human milk data, so use during lactation should be discussed with the prescribing clinician.
Can children or older adults use Tyrvaya?
Safety and effectiveness have not been established in pediatric patients. In older adults, the label reports no overall differences in safety or effectiveness compared with younger adults.
How should Tyrvaya be stored?
Store it at room temperature, 68°F to 77°F (20°C to 25°C), and do not freeze it. Each bottle should be discarded 30 days after first opening, and one carton contains 2 bottles that together provide a 30-day supply.
