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USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses. Clinical Considerations Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of BromSite during late pregnancy should be avoided. Data Animal Data Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m 2 basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m 2 basis) produced no structural teratogenicity in reproduction studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation There are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects on milk production; however, systemic exposure to bromfenac from ocular administration is low. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bromfenac and any potential adverse effects on the breast-fed child from bromfenac or from the underlying maternal condition. Pediatric Use Safety and efficacy in pediatric patients below the age of 18 years have not been established. Geriatric Use There is no evidence that the efficacy or safety profiles for BromSite differ in patients 65 years of age and older compared to younger adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (129 times a unilateral daily dose assuming 100% absorbed, on a mg/m 2 basis) and 5 mg/kg/day (540 times a unilateral daily dose on a mg/m 2 basis), respectively revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the bacterial reverse mutation, chromosomal aberration, and micronucleus tests. Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (195 and 65 times a unilateral daily dose, respectively, on a mg/m 2 basis). PATIENT COUNSELING INFORMATION Slow or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, advise patients to administer BromSite at least 5 minutes after instillation of other topical medications. Concomitant Use of Contact Lenses Advise patients not to wear contact lenses during administration of BromSite. The preservative in this product, benzalkonium chloride, may be absorbed by soft contact lenses. Sterility of Dropper Tip/Product Use Advise patients to replace the bottle cap after use and do not touch the dropper tip to any surface as this may contaminate the contents. Advise patients to thoroughly wash hands prior to using BromSite. Rx Only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 BromSite is a trademark of Sun Pharma Global FZE. SUN-OPH-BRO-017 09/2016 INDICATIONS AND USAGE BromSite™ (bromfenac ophthalmic solution) 0.075% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. DOSAGE AND ADMINISTRATION Recommended Dosing One drop of BromSite should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery. Use with Other Topical Ophthalmic Medications BromSite should be administered at least 5 minutes after instillation of other topical medications. Dosage Forms and Strengths Topical ophthalmic solution: bromfenac 0.075%. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite (bromfenac ophthalmic solution) 0.075%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. Increased Bleeding Time of Ocular Tissue With some NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that BromSite be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%, and should be closely monitored for corneal health. Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events. Contact Lens Wear BromSite should not be administered while wearing contact lenses. The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses. ADVERSE REACTIONS Clinical Trial 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 clinical practice. The most commonly reported adverse reactions in 1–8% of patients were: anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain and ocular hypertension. BromSite™ (bromfenac ophthalmic solution) 0.075% Brief Summary

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