This information is not for clinical use. These highlights do not include all the information needed to use Ilevro safely and effectively. Before taking Ilevro please consult with your doctor. See full prescribing information for Ilevro.

Indications And Usage

SECTION ILEVRO* (nepafenac ophthalmic suspension), 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO* (nepafenac ophthalmic suspension), 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery (1).

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Dosage Forms And Strengths

SECTION Sterile ophthalmic suspension 0.3% 1.7 mL in a 4 mL bottle 3 mL in a 4 mL bottle Sterile ophthalmic suspension 0.3%: 1.7 mL in a 4 mL bottle and 3 mL in a 4 mL bottle. (3)

Contraindications

SECTION ILEVRO* (nepafenac ophthalmic suspension), 0.3% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs. Hypersensitivity to any of the ingredients in the formula or to other NSAIDS.(4)

Warning and Cautions

SECTION Increased bleeding time due to interference with thrombocyte aggregation (5.1) Delayed healing (5.2) Corneal effects including keratitis (5.3) 5.1 Increased Bleeding Time With some nonsteroidal anti-inflammatory drugs including ILEVRO* (nepafenac ophthalmic suspension), 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery. It is recommended that ILEVRO* (nepafenac ophthalmic suspension), 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 5.2 Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including ILEVRO* (nepafenac ophthalmic suspension), 0.3%, 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. 5.3 Corneal Effects 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 ILEVRO* (nepafenac ophthalmic suspension), 0.3% and should be closely monitored for corneal health. Postmarketing 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. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events. 5.4 Contact Lens Wear ILEVRO* (nepafenac ophthalmic suspension), 0.3% should not be administered while using contact lenses.

Adverse Reactions

SECTION 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 the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most common adverse reactions (5 to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Serious and Otherwise Important Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of labeling. Increased Bleeding Time (Warnings and Precautions 5.1) Delayed Healing (Warnings and Precautions 5.2) Corneal Effects (Warnings and Precautions 5.3) 6.2 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these reactions may be the consequence of the cataract surgical procedure. 6.3 Non-Ocular Adverse Reactions Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

Use In Specific Populations

SECTION 8.1 Pregnancy Section Teratogenic Effects. Pregnancy Category C: Reproduction studies performed with nepafenac in rabbits and rats at oral doses up to 10 mg/kg/day have revealed no evidence of teratogenicity due to nepafenac, despite the induction of maternal toxicity. At this dose, the animal plasma exposure to nepafenac and amfenac was approximately 70 and 630 times human plasma exposure at the recommended human topical ophthalmic dose for rats and 20 and 180 times human plasma exposure for rabbits, respectively. In rats, maternally toxic doses ≥ 10 mg/kg were associated with dystocia, increased postimplantation loss, reduced fetal weights and growth, and reduced fetal survival. Nepafenac has been shown to cross the placental barrier in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ILEVRO* (nepafenac ophthalmic suspension), 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Non-teratogenic Effects. Because of the known effects of prostaglandin biosynthesis inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ILEVRO* (nepafenac ophthalmic suspension), 0.3% during late pregnancy should be avoided. 8.3 Nursing Mothers Section Nepafenac is excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ILEVRO* (nepafenac ophthalmic suspension), 0.3% is administered to a nursing woman. 8.4 Pediatric Use Section The safety and effectiveness of ILEVRO* (nepafenac ophthalmic suspension), 0.3% in pediatric patients below the age of 10 years have not been established. 8.5 Geriatric Use Section No overall differences in safety and effectiveness have been observed between elderly and younger patients.