Eyeworld

Postmarketing Experience The following reaction has been identified during postmarketing use of FLAREX in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes dysgeusia. USE IN SPECIFIC POPULATIONS Pregnancy Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs, and neural abnormalities, such as encephalocele, craniorachischisis, and spina bifida, were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX is administered to a nursing woman. 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 younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone. PATIENT COUNSELING INFORMATION Risk of Contamination Do not touch dropper tip to any surface, as this may contaminate the suspension. Use with Contact Lenses The preservative in FLAREX, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX but may be reinserted 15 minutes after instillation. Temporarily Blurred Vision Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX. Care should be exercised in operating machinery or driving a motor vehicle. Rx Only Distributed by: Eyevance Pharmaceuticals LLC. Fort Worth, TX 76102 References: 1. FLAREX [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; 2017. 2. Leibowitz HM, Hyndiuk RA, Lindsey C, et al. Fluorometholone acetate: clinical evaluation in the treatment of external ocular inflammation. Ann Ophthalmol. 1984;16(12):1110-1115. 3. Data on file. Fort Worth, TX: Eyevance Pharmaceuticals LLC. 4. US Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. (Orange Book). 38th ed. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2018. FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% Brief Summary INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. DOSAGE AND ADMINISTRATION Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely. CONTRAINDICATIONS Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation. WARNINGS AND PRECAUTIONS Topical Ophthalmic Use Only For topical ophthalmic use only. Not for injection. Intraocular Pressure Increase Prolonged use may result in glaucoma, damage to the optic nerve, and defects in visual acuity and visual field. It is advisable that the intraocular pressure be checked frequently. Cataracts Use of corticosteroids may result in cataract formation. Delayed Healing Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. Viral Infections Use in the treatment of herpes simplex infection requires great caution. Bacterial Infections Use of corticosteroids may suppress the host response and thus aid in the establishment of secondary ocular infections. Acute purulent infections of the eye may be masked or exacerbated by the presence of steroid medication. Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Contamination Do not touch dropper tip to any surface, as this may contaminate the suspension. Contact Lens Wear Contact lenses should be removed during instillation of FLAREX but may be reinserted after 15 minutes. Temporarily Blurred Vision Vision may be temporarily blurred following dosing with FLAREX. Care should be exercised in operating machinery or driving a motor vehicle. ADVERSE REACTIONS Clinical Trials Experience Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur. © 2019 Eyevance Pharmaceuticals LLC. All rights reserved. FLAREX ® is a registered trademark of Alcon Research, Ltd. FLA-09-19-AD-40

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