Acoltremon
FDA Drug Information • Also known as: Tryptyr
- Brand Names
- Tryptyr
- Route
- OPHTHALMIC, TOPICAL
- Dosage Form
- SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION TRYPTYR (acoltremon ophthalmic solution) 0.003% contains an agonist of TRPM8 ion channels. Acoltremon’s chemical name is (1 R ,2 S ,5 R )-2-isopropyl- N -(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide. The molecular formula of acoltremon is C 18 H 27 NO 2 and has a molecular weight of 289.42 g/mol. Acoltremon is a white to pale yellow crystalline solid, that is insoluble in water. TRYPTYR is a sterile, clear to slightly opalescent, colorless, isotonic aqueous solution for topical ophthalmic use, with a pH of approximately 7 and an osmolality of 280 to 330 mOsm/kg. Each mL of TRYPTYR contains active: acoltremon 0.003%; and inactives: polyoxyl 35 castor oil, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose and purified water. Additionally, sodium hydroxide is used to adjust pH. TRYPTYR does not contain an anti-microbial preservative.
What Is Acoltremon Used For?
1 INDICATIONS AND USAGE TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Instill one drop in each eye twice daily (approximately 12 hours apart). ( 2 ) 2.1 Recommended Dosage Instill one drop in each eye twice daily (approximately 12 hours apart). 2.2 Administration Instructions Wash hands before use. The single-dose vials are to be used immediately after opening and can be used to dose both eyes. Discard the single-dose vial, including any remaining contents, immediately after use. TRYPTYR can be used concomitantly with other topical ophthalmic eye drops. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart . Contact lenses should be removed prior to the administration of TRYPTYR and may be reinserted 15 minutes following administration. If one dose is missed, treatment should continue with the next dose.
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The most common adverse reaction was instillation site pain (50%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9780, 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 patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States. The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%). Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies on TRYPTYR in pregnant women. Systemic exposure to acoltremon from ocular administration is negligible [see Clinical Pharmacology ( 12.3 )] . Intravenous administration of acoltremon to pregnant rats and rabbits during organogenesis did not produce embryofetal toxicity at 806- and 2151-fold the maximum recommended human ocular dose (MRHOD) of acoltremon on a mg/m 2 basis ( see Data ) . All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal developmental studies in pregnant rats and rabbits dosed by intravenous injection daily during organogenesis from gestation days 6-17 and gestation days 7-19, respectively, no maternal or fetal toxicity was observed at 806- and 2151-fold the MRHOD of acoltremon on a mg/m 2 basis.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING TRYPTYR (acoltremon ophthalmic solution) 0.003% is supplied as a sterile, clear to slightly opalescent, and colorless solution in a low-density polyethylene (LDPE), single-dose vial with a 0.4 mL fill. One strip of 5 single-dose vials is packaged in a foil pouch with twelve (12) pouches in a carton. NDC 0065-8595-02; Carton of 60 Single-Dose Vials. Storage Store refrigerated at 2°C to 8°C (36°F to 46°F). After opening the carton, TRYPTYR may be stored refrigerated or at room temperature at 2°C to 25°C (36°F to 77°F). If stored at room temperature, TRYPTYR should be used within 30 days, not to exceed the expiration date printed on the carton and foil pouch. After opening each foil pouch, the single-dose vials should be used within 7 days, not to exceed the expiration date printed on the vial. Store unopened single-dose vials in the original foil pouch until ready to use.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.