Acoltremon
Generic Name: acoltremon
Brand Names:
Tryptyr
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.
Overview
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.
Uses
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
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.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. 5.2 Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
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.
Storage
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.
Frequently Asked Questions
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 )
What are the side effects of Acoltremon?▼
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.
Can I take Acoltremon during pregnancy?▼
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.
What are the important warnings for Acoltremon?▼
5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. 5.2 Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.