Latanoprost and Netarsudil

1. INDICATIONS AND USAGE ROCKLATAN is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ROCKLATAN ® is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

ROCKLATAN is comprised of two components: netarsudil and latanoprost. Each of these two components decreases elevated IOP. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and glaucomatous visual field loss. ROCKLATAN is believed to reduce IOP by increasing the outflow of aqueous humor.

2. DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. The dosage of ROCKLATAN should not exceed once daily. ROCKLATAN may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. One drop in the affected eye(s) once daily in the evening.

4. CONTRAINDICATIONS None. None.

5. WARNINGS AND PRECAUTIONS • Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. • Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible.

6. ADVERSE REACTIONS The most common adverse reaction is conjunctival hyperemia (59%). Other common adverse reactions were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%).

7. DRUG INTERACTIONS In vitro drug interaction studies have shown that precipitation can occur when eye drops containing thimerosal are mixed with ROCKLATAN. If such drugs are used, they should be administered at least five minutes apart. The combined use of two or more prostaglandins or prostaglandin analogs including latanoprost ophthalmic solution 0.005% is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Thimerosal: In vitro studies have shown that precipitation can occur when eye drops containing thimerosal are mixed with ROCKLATAN ®. If such drugs are used, they should be administered at least 5 minutes apart.

Until opened, store at 2°C to 8°C (36°F to 46°F). During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. Protect from light. After opening, the product may be kept at 2°C to 25°C (36°F to 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C to 8°C (36°F to 46°F), then the product can be used until the expiration date stamped on the bottle.