Travoprost

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The recommended dosage is one drop in the affected eye(s) once daily in the evening. Travoprost ophthalmic solution (ionic buffered solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP lowering effect. Reduction of the IOP starts approximately 2 hours after the first administration with maximum effect reached after 12 hours. Travoprost ophthalmic solution (ionic buffered solution) may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure (IOP). If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Ophthalmic solution containing travoprost 0.04 mg/mL.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

11 DESCRIPTION

DESCRIPTION SECTION

Travoprost is a synthetic prostaglandin F analogue. Its chemical name is [1 R -[1α( Z ),2β(1 E ,3 R *),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl) phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C 26 H 35 F 3 O 6 and a molecular weight of 500.55 g/mol. The chemical structure of travoprost is: Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution, USP (ionic buffered solution) contains Active: travoprost 0.04 mg/mL; Inactives: polyoxyl 40 hydrogenated castor oil, ionic buffered system (boric acid, propylene glycol, sorbitol, zinc chloride), sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. Preserved in the bottle with an ionic buffered system.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25 to 27 mmHg, who were treated with travoprost ophthalmic solution 0.004% or travoprost ophthalmic solution (ionic buffered solution) 0.004% dosed once daily in the evening, demonstrated 7 to 8 mmHg reductions in IOP. In sub-group analyses of these studies, mean IOP reduction in black patients was up to 1.8 mmHg greater than in non-black patients. It is not known at this time whether this difference is attributed to race or to heavily pigmented irides. In a multi-center, randomized, controlled trial, patients with mean baseline IOP of 24 to 26 mmHg on TIMOPTIC** 0.5% twice daily who were treated with travoprost ophthalmic solution 0.004% dosed daily adjunctively to TIMOPTIC** 0.5% twice daily demonstrated 6 to 7 mmHg reductions in IOP.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% is supplied as a 2.5 mL solution and a 5 mL solution in a 5 mL translucent polypropylene ophthalmic bottle with a translucent polypropylene ophthalmic dropper and a turquoise, opaque polypropylene cap. 2.5 mL fill NDC 60505-0593-4 5 mL fill NDC 60505-0593-1 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, travoprost ophthalmic solution, USP (ionic buffered solution) 0.004% can be used until the expiration date on the bottle.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Potential for Pigmentation Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. Inform the patient about the possibility of eyelid skin darkening, which may be reversible after discontinuation of travoprost ophthalmic solution (ionic buffered solution) 0.004% [see Warnings and Precautions (5.1)]. Potential for Eyelash Changes Inform the patient about the possibility of eyelash and vellus hair changes in the treated eye during treatment with travoprost ophthalmic solution (ionic buffered solution). These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment [ see Warnings and Precautions (5.2)]. Handling the Container Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions (5.6)]. When to Seek Physician Advice Advise the patient that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of travoprost ophthalmic solution (ionic buffered solution) [see Warnings and Precautions (5.3, 5.4, 5.5)]. Use with Contact Lenses Contact lenses should be removed prior to instillation of travoprost ophthalmic solution (ionic buffered solution) and may be reinserted 15 minutes following its administration [see Warnings and Precautions (5.7)]. Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. Rx Only * TIMOPTIC is a registered trademark of Merck & Co., Inc. Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada, M9L 1T9 33326 March 2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 2.5 mL APOTEX CORP. NDC 60505-0593-4 Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution) 0.004% Equivalent to 0.04 mg travoprost Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 2.5 mL APOTEX CORP. NDC 60505-0593-4 Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution) 0.004% Equivalent to 0.04 mg travoprost Rx Only