General: Topical non-steroidal anti-inflammatory drugs (NSAIDs), including nepafenac (Nevanac) Sterile Ophthalmic Suspension, 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.
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 nepafenac (Nevanac) Sterile Ophthalmic Suspension 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 patients with repeat and/or complex ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases, dry eye or rheumatoid arthritis may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions.
Information for Patients: Nepafenac (Nevanac) Sterile Ophthalmic Suspension should not be administered while wearing contact lenses.
Effects on ability to drive and use machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at application, the patient must wait until the vision clears before driving or using machinery.
Use in hepatic and renal impairment: Nepafenac has not been studied in patients with hepatic disease or renal impairment. No dose adjustment is warranted in these patients, as the systemic exposure is very low following topical ocular administration.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Nepafenac has not been evaluated in long-term carcinogenicity studies. Increased chromosomal aberrations were observed in Chinese hamster ovary cells exposed in vitro to nepafenac suspension. Nepafenac was not mutagenic in the Ames assay or in the mouse lymphoma forward mutation assay. Oral doses up to 5,000 mg/kg did not result in an increase in the formation of micronucleated polychromatic erythrocytes in vivo in the mouse micronucleus assay in the bone marrow of mice.
Nepafenac did not impair fertility when administered orally to male and female rats at 3 mg/kg (approximately 90 and 380 times the plasma exposure to the parent drug, nepafenac, and the active metabolite, amfenac, respectively, at the recommended human topical ophthalmic dose).
There are no adequate data regarding the use of nepafenac (Nevanac) Sterile Ophthalmic Suspension on human fertility. No significant fertility effects were seen in studies in rats at doses up to 2500 times greater than the maximum recommended human ocular dose.
Use in Pregnancy: Teratogenic Effects.
Pregnancy Category C: There are no adequate data regarding the use of nepafenac (Nevanac) on human pregnancy. No significant teratogenic effects were observed in rats and rabbits orally administered with doses of nepafenac up to 2500 times greater than the maximum recommended human ocular dose. Since human systemic exposure is negligible (< 1 ng/mL) after treatment with nepafenac (Nevanac), the risk during pregnancy could be considered low. Nevertheless, inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/fetal development and/or parturition and/or postnatal development.
Nepafenac (Nevanac) is not recommended during pregnancy unless the benefit outweighs the potential risk.
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 nepafenac (Nevanac) Sterile Ophthalmic Suspension during late pregnancy should be avoided.
Use in Lactation: Nepafenac (Nevanac) Sterile Ophthalmic Suspension is excreted in the milk of pregnant rats. It is unknown whether nepafenac is excreted in human milk after topical administration. Because many drugs excreted in human milk, caution should be exercised when nepafenac (Nevanac) Sterile Ophthalmic Suspension is administered to a nursing woman. Animal studies have shown excretion of nepafenac in the milk of rats after oral administration. While no effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to nepafenac is negligible (<1 ng/mL), caution should be exercised when nepafenac (Nevanac) is administered to a nursing woman.
Use in Children: The safety and effectiveness of nepafenac (Nevanac) Sterile Ophthalmic Suspension in pediatric patients below the age of 10 years have not been established. Its use is not recommended in these patients until further data become available.
Use in Elderly: No overall differences in safety and effectiveness have been observed between elderly and younger patients.