Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TYRVAYA (varenicline solution) nasal spray is available in a carton containing two (2) nasal spray amber glass Type I bottles. Each bottle consists of a white nasal pump and blue dust cover, delivering 0.03 mg varenicline per spray (0.05 mL). Each bottle delivers one spray in each nostril twice daily for 15 days. Two nasal spray bottles in each carton, containing 60 sprays per bottle, equivalent to 30-days’ supply with one spray in each nostril twice daily (NDC 73521-030-02). 16.2 Storage and Handling • Store TYRVAYA nasal spray at 20°C to 25°C (68°F to 77°F). Do not freeze. • Discard TYRVAYA nasal spray bottle 30 days after opening bottle.; 16.1 How Supplied TYRVAYA (varenicline solution) nasal spray is available in a carton containing two (2) nasal spray amber glass Type I bottles. Each bottle consists of a white nasal pump and blue dust cover, delivering 0.03 mg varenicline per spray (0.05 mL). Each bottle delivers one spray in each nostril twice daily for 15 days. Two nasal spray bottles in each carton, containing 60 sprays per bottle, equivalent to 30-days’ supply with one spray in each nostril twice daily (NDC 73521-030-02).; PRINCIPAL DISPLAY PANEL - NASAL SPRAY 0.03 mg NDC 73521-030-02 tyrvaya ® (varenicline solution) nasal spray 0.03 mg 2 nasal spray bottles for a 30-day supply Each bottle contains 60 sprays (Net Content 4.2 mL per bottle) FOR INTRANASAL USE Rx only. Each 50 μL spray contains: varenicline 0.03 mg (equivalent to 0.05 mg 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. Manufactured for: Oyster Point Pharma, Inc. Princeton, NJ 08540 1-877-EYE-0123 Store Tyrvaya between 20°C to 25°C (68°F to 77°F). Do not freeze. Do not shake the bottles. Discard individual bottle of Tyrvaya 30 days after first use. Keep Tyrvaya and all medicines out of the reach of children. 02TRADCTN, Rev 2.0 IMPORTANT Read enclosed Patient Information and Instructions for Use for priming, dosing, and re-priming information. PRIME BEFORE FIRST USE. FOR INTRANASAL USE. Tyrvaya, Oyster Point, and the respective logos are registered trademarks of Oyster Point Pharma, Inc. 0.03 mg Carton Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TYRVAYA (varenicline solution) nasal spray is available in a carton containing two (2) nasal spray amber glass Type I bottles. Each bottle consists of a white nasal pump and blue dust cover, delivering 0.03 mg varenicline per spray (0.05 mL). Each bottle delivers one spray in each nostril twice daily for 15 days. Two nasal spray bottles in each carton, containing 60 sprays per bottle, equivalent to 30-days’ supply with one spray in each nostril twice daily (NDC 73521-030-02). 16.2 Storage and Handling • Store TYRVAYA nasal spray at 20°C to 25°C (68°F to 77°F). Do not freeze. • Discard TYRVAYA nasal spray bottle 30 days after opening bottle.
- 16.1 How Supplied TYRVAYA (varenicline solution) nasal spray is available in a carton containing two (2) nasal spray amber glass Type I bottles. Each bottle consists of a white nasal pump and blue dust cover, delivering 0.03 mg varenicline per spray (0.05 mL). Each bottle delivers one spray in each nostril twice daily for 15 days. Two nasal spray bottles in each carton, containing 60 sprays per bottle, equivalent to 30-days’ supply with one spray in each nostril twice daily (NDC 73521-030-02).
- PRINCIPAL DISPLAY PANEL - NASAL SPRAY 0.03 mg NDC 73521-030-02 tyrvaya ® (varenicline solution) nasal spray 0.03 mg 2 nasal spray bottles for a 30-day supply Each bottle contains 60 sprays (Net Content 4.2 mL per bottle) FOR INTRANASAL USE Rx only. Each 50 μL spray contains: varenicline 0.03 mg (equivalent to 0.05 mg 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. Manufactured for: Oyster Point Pharma, Inc. Princeton, NJ 08540 1-877-EYE-0123 Store Tyrvaya between 20°C to 25°C (68°F to 77°F). Do not freeze. Do not shake the bottles. Discard individual bottle of Tyrvaya 30 days after first use. Keep Tyrvaya and all medicines out of the reach of children. 02TRADCTN, Rev 2.0 IMPORTANT Read enclosed Patient Information and Instructions for Use for priming, dosing, and re-priming information. PRIME BEFORE FIRST USE. FOR INTRANASAL USE. Tyrvaya, Oyster Point, and the respective logos are registered trademarks of Oyster Point Pharma, Inc. 0.03 mg Carton Label
Overview
TYRVAYA nasal spray contains varenicline which is a partial nicotinic acetylcholine receptor agonist of α4β2, α4α6β2, α3β4, and α3α5β4 receptors and a full α7 receptor agonist. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid whose chemical name is 7,8,9,10-tetrahydro-6,10-methano-6 H -pyrazino[2,3-h][3]benzazepine, (2 R ,3 R )-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons and a molecular formula of C 13 H 13 N 3 ⋅ C 4 H 6 O 6 . The chemical structure is: TYRVAYA (varenicline solution) nasal spray is formulated for intranasal use as a clear 0.6 mg/mL strength solution, at pH 6.4. After priming [see Dosage and Administration ( 2.2 )] , each actuation delivers a 0.05 mL spray containing 0.03 mg varenicline free base, equivalent to 0.05 mg of varenicline tartrate. The formulation also contains the following 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. The chemical structure
Indications & Usage
TYRVAYA (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. TYRVAYA (varenicline solution) nasal spray is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage & Administration
• One spray in each nostril twice daily (approximately 12 hours apart). ( 2.1 ) • Prime with seven (7) actuations before initial use. Re-prime with 1 actuation if not used for more than five (5) days. ( 2.2 ) 2.1 Dosing Information Spray TYRVAYA once in each nostril twice daily (approximately 12 hours apart). If a dose is missed, resume regular dosing at the next scheduled dose time. 2.2 Priming Instructions Priming : Prime TYRVAYA before initial use by pumping seven (7) actuations into the air away from the face. When TYRVAYA has not been used for more than 5 days, re-prime with 1 spray into the air. Do not shake.
Warnings & Precautions
No warnings available yet.
Contraindications
None None.
Adverse Reactions
The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oyster Point Pharma at 1-877-EYE-0123 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In three clinical studies of dry eye disease conducted with varenicline solution nasal spray, 349 patients received at least 1 dose of TYRVAYA. The majority of patients had 31 days of treatment exposure, with a maximum exposure of 105 days. The most common adverse reactions reported in 82% of TYRVAYA treated patients was sneezing. Other common adverse reactions that were reported in >5% of patients include cough (16%), throat irritation (13%), and instillation-site (nose) irritation (8%).
Storage & Handling
16.2 Storage and Handling • Store TYRVAYA nasal spray at 20°C to 25°C (68°F to 77°F). Do not freeze. • Discard TYRVAYA nasal spray bottle 30 days after opening bottle.
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