LATANOPROST Drug Interactions: What You Need to Know

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 (5) 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. ( 7 )

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. ( 4 )

5. WARNINGS AND PRECAUTIONS

• Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.2 )
• Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.3 )

5.1 Epithelial Corneal Edema ROCKLATAN contains netarsudil which has been associated with Epithelial corneal edema, described as honeycomb or bullous, and has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures that could affect corneal endothelial function. Epithelial corneal edemal typically resolves upon discontinuation of ROCKLATAN. Advise patients to notify their physician if they experience eye pain or decreased vision while using ROCKLATAN <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.2 ) and Patient Counselling Information ( 17 )]</span> .

5.2 Pigmentation ROCKLATAN contains latanoprost which has 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.

Beyond

5 years the 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 ROCKLATAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly [see Patient Counseling Information ( 17 ) ].

5.3 Eyelash Changes ROCKLATAN contains latanoprost which 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 <span class="opacity-50 text-xs">[see Patient Counseling Information ( 17 ) ]</span>.

5.4 Intraocular Inflammation ROCKLATAN contains latanoprost which 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 it may exacerbate inflammation.

5.5 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost. ROCKLATAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

5.6 Herpetic Keratitis Reactivation of Herpes Simplex keratitis has been reported during treatment with latanoprost. ROCKLATAN should be used with caution in patients with a history of herpetic keratitis. ROCKLATAN should be avoided in cases of active herpes simplex keratitis because it may exacerbate inflammation.

5.7 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface <span class="opacity-50 text-xs">[see Patient Counseling Information ( 17 )]</span>.

5.8 Use with Contact Lenses Contact lenses should be removed prior to the administration of ROCKLATAN and may be reinserted 15 minutes after administration.