Bromfenac Ophthalmic Solution

None. None. ( 4 )

• Sulfite Allergic Reactions ( 5.1 ) Slow or Delayed Healing ( 5.2 ) Potential for Cross-Sensitivity ( 5.3 ) Increased Bleeding Time ( 5.4 ) Keratitis and Corneal Reactions ( 5.5 )
• 5.1 Sulfite Allergic Reactions Bromfenac Ophthalmic Solution contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
• Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
• 5.2 Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, 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 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac.
• Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
• 5.4 Increased Bleeding Time With some NSAIDs, including bromfenac, 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 Bromfenac Ophthalmic Solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
• 5.5 Keratitis and Corneal Reactions Use of topical NSAIDs, including bromfenac, 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 bromfenac, 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 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events.
• 5.6 Risk of Contamination Do not touch dropper tip to the eye, eyelids, or to any surface, as this may contaminate the contents.
• Replace the bottle cap after using.
• 5.7 Contact Lens Wear Bromfenac Ophthalmic Solution should not be instilled while wearing contact lenses.

• Risk Summary There are no available data on Bromfenac Ophthalmic Solution use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
• The systemic exposure to bromfenac following topical ocular administration is low [see Clinical Pharmacology ( 12.3 )].
• Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal following topical ocular administration.
• However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Bromfenac Ophthalmic Solution during late pregnancy should be avoided.
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
• All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
• In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
• Clinical Considerations Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs.
• Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration.
• The maternal plasma level of Bromfenac Ophthalmic Solution following ocular administration is unknown [see Clinical Pharmacology ( 12.3 )].
• Data Animal Data Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively.
• These doses corresponded to a Cmax 90- and 150- times the predicted Cmax at the recommended human ophthalmic dose (RHOD), respectively.
• In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human Cmax at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human Cmax at the RHOD).
• IN SPECIFIC POPULATIONS
• 8.1 Pregnancy Risk Summary There are no available data on Bromfenac Ophthalmic Solution use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
• The systemic exposure to bromfenac following topical ocular administration is low [see Clinical Pharmacology ( 12.3 )].
• Consequently, the systemic exposure of a pregnant woman to bromfenac is expected to be minimal following topical ocular administration.
• However, because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Bromfenac Ophthalmic Solution during late pregnancy should be avoided.
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
• All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
• In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
• Clinical Considerations Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs.
• Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration.
• The maternal plasma level of Bromfenac Ophthalmic Solution following ocular administration is unknown [see Clinical Pharmacology ( 12.3 )].
• Data Animal Data Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively.
• These doses corresponded to a Cmax 90- and 150- times the predicted Cmax at the recommended human ophthalmic dose (RHOD), respectively.
• In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human Cmax at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human Cmax at the RHOD).
• 8.2 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.
• The systemic exposure of a breastfeeding woman to bromfenac is expected to be minimal following topical ocular administration, however, the possibility of harm to the breastfed infant cannot be ruled out.
• The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Bromfenac Ophthalmic Solution, and any potential adverse effects on the breastfed infant from Bromfenac Ophthalmic Solution or from the underlying maternal conditions.
• 8.4 Pediatric Use The safety and effectiveness of Bromfenac Ophthalmic Solution have not been established in pediatric patients.
• 8.5 Geriatric Use No overall differences in safety or effectiveness of Bromfenac Ophthalmic Solution have been observed between patients 70 years of age and older and younger adult patients.