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Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Rx Only BRIEF SUMMARY Consult the Full Prescribing Information for complete product information. INDICATIONS AND USAGE Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. DOSAGE AND ADMINISTRATION e 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. e 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 (5) minutes apart. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Pigmentation Rocklatan® contains latanoprost which has been reported to cause changes to pigmented tissues. e 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. e pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. Aer discontinuation, 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. 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. 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. 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... 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. 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. Bacterial Keratitis ere have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. ese containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Use with Contact Lenses Contact lenses should be removed prior to the administration of Rocklatan® and may be reinserted 15 minutes aer administration. ADVERSE REACTIONS Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Rocklatan® e most common ocular adverse reaction observed in controlled clinical studies with Rocklatan® was conjunctival hyperemia which was reported in 59% of patients. Five percent of patients discontinued therapy due to conjunctival hyperemia. Other common ocular adverse reactions reported were: instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%). Eye pruritus, visual acuity reduced, increased lacrimation, instillation site discomfort, and blurred vision were reported in 5-8% of patients. Other adverse reactions that have been reported with the individual components and not listed above include: Netarsudil 0.02% Instillation site erythema, corneal staining, increased lacrimation and erythema of eyelid. Latanoprost 0.005% Foreign body sensation, punctate keratitis, burning and stinging, itching, increased pigmentation of the iris, excessive tearing, eyelid discomfort, dry eye, eye pain, eyelid margin crusting, erythema of the eyelid, upper respiratory tract infection/nasopharyngitis/influenza, photophobia, eyelid edema, myalgia/ arthralgia/back pain, and rash/allergic reactions. DRUG INTERACTIONS Although specific drug interaction studies have not been conducted with Rocklatan®, in vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost ophthalmic solution 0.005%. If such drugs are used, they should be administered at least five (5) minutes apart. e 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. USE IN SPECIFIC POPULATIONS Pregnancy ere are no available data on netarsudil ophthalmic solution use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low. Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures. Animal Data Netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the RHOD, based on C max ). e no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C max ). Netarsudil administered daily by intravenous injection to rabbits during organogenesis caused embryofetal lethality and decreased fetal weight at 5 mg/kg/day (1480-fold the plasma exposure at the RHOD, based on C max ). Malformations were observed at ≥3 mg/kg/day (1330-fold the plasma exposure at the RHOD, based on C max ), including thoracogastroschisis, umbilical hernia and absent intermediate lung lobe. e NOAEL for embryofetal development toxicity was 0.5 mg/kg/day (214-fold the plasma exposure at the RHOD, based on C max ). For latanoprost, in 4 of 16 pregnant rabbits, no viable fetuses were present at a dose that was approximately 80 times higher than the RHOD. Latanoprost did not produce embryofetal lethality in rabbits at a dose approximately 15 times higher than the RHOD. Lactation ere are no data on the presence of netarsudil or latanoprost in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to netarsudil following topical ocular administration is low, and it is not known whether measurable levels of netarsudil would be present in maternal milk following topical ocular administration. It is also not known whether latanoprost or its metabolites are excreted in milk. e developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Rocklatan® and any potential adverse effects on the breastfed child from netarsudil and latanoprost. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil. Netarsudil was not mutagenic in the Ames test, in the mouse lymphoma test, or in the in vivo rat micronucleus test. Studies to evaluate the effects of netarsudil on male or female fertility in animals have not been performed. Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of up to 170 mcg/kg/day (approximately 2800 times the recommended maximum human dose) for up to 20 and 24 months, respectively. Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes. Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative. Latanoprost has not been found to have any effect on male or female fertility in animal studies. For additional information, refer to the full prescribing information at www.Rocklatan.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Manufactured for: Aerie Pharmaceuticals, Inc., Irvine, CA 92614, U.S.A. Rocklatan® is a registered trademark of Aerie Pharmaceuticals, Inc. U.S. Patent Nos.: 8,450,344; 8,394,826; 9,096,569; 9,415,043; 9,931,336; 9,993,470

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