IYUZEH

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 as normal. The dosage of IYUZEH should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH 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. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

IYUZEH may be used concomitantly with other topical ophthalmic drug products to lower IOP. 005% latanoprost reference product. 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 IYUZEH and may be reinserted 15 minutes after administration. The solution from one individual unit is to be used immediately after opening for administration to one or both eyes.

Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration. One drop in the affected eye(s) once daily in the evening. ( 2 )

4) ] Most common adverse reactions (5% to 35%) for IYUZEH are: conjunctival hyperemia, eye irritation, eye pruritus, abnormal sensation in eye, foreign body sensation in eyes, vision blurred and lacrimation increased. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc.

gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. 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.

005% latanoprost reference product, the most frequently reported ocular adverse reactions were conjunctival hyperemia and eye irritation ( Table 1 ). Table 1. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of topical latanoprost products.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ophthalmic latanoprost products, or a combination of these factors, include: Nervous System Disorders: Dizziness; headache; toxic epidermal necrolysis Eye Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid skin darkening; localized skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva.

5 WARNINGS AND PRECAUTIONS Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. 1 ) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes.

Usually, reversible. 1 Pigmentation Topical latanoprost ophthalmic products, including IYUZEH have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes.

Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients.

Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.

Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with IYUZEH can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 2 Eyelash Changes Latanoprost ophthalmic products, including IYUZEH may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes.

Eyelash changes are usually reversible upon discontinuation of treatment. 3 Intraocular Inflammation IYUZEH should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated.

4 CONTRAINDICATIONS Known hypersensitivity to latanoprost or any other ingredients in this product. Known hypersensitivity to latanoprost or any other ingredients in this product. ( 4 )