Eyeworld Daily News

EW SHOW DAILY 18 Sunday, April 19, 2015 ASCRS News Today INDICATIONS AND USAGE PROLENSA ® (bromfenac ophthalmic solution) 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. DOSAGE AND ADMINISTRATION Recommended Dosing One drop of PROLENSA ® ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. Use with Other Topical Ophthalmic Medications PROLENSA ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta- blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Sulfite Allergic Reactions 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. 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. 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. 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 PROLENSA ® ophthalmic solution 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 bromfenac, 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 post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. Contact Lens Wear PROLENSA should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA, benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA. 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 following use of PROLENSA ® ophthalmic solution following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia and vision blurred. These reactions were reported in 3 to 8% of patients. USE IN SPECIFIC POPULATIONS Pregnancy Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and reduced postnatal growth at 0.9 mg/kg/day. There are no adequate and well-controlled studies in pregnant women. 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. Because of the known effects of prostaglandin biosynthesis- inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of PROLENSA ® ophthalmic solution during late pregnancy should be avoided. Nursing Mothers Caution should be exercised when PROLENSA is administered to a nursing woman. Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established. Geriatric Use There is no evidence that the efficacy or safety profiles for PROLENSA differ in patients 70 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 (systemic exposure 30 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and 5 mg/kg/day (340 times the predicted human systemic exposure), respectively, revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the 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 (systemic exposure 90 and 30 times the predicted human exposure, respectively). PATIENT COUNSELING INFORMATION Slowed or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Sterility of Dropper Tip Advise patients to replace bottle cap after using and to not touch dropper tip to any surface, as this may contaminate the contents. Advise patients that a single bottle of PROLENSA ® ophthalmic solution, be used to treat only one eye. Concomitant Use of Contact Lenses Advise patients to remove contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Rx Only Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637 Under license from: Senju Pharmaceuticals Co., Ltd. Osaka, Japan 541-0046 Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates. © Bausch & Lomb Incorporated. 9317600 US/PRA/14/0024 PROLENSA ® (bromfenac ophthalmic solution) 0.07% Brief Summary S:7" S:10" T:7.75" T:10.75" B:7.75" B:10.75" beginning of baseball season with a fun, casual event at Petco Park, home of the San Diego Padres. Approximately 150 guests attended the event, celebrating the T his year's eyePAC reception following the ASCRS•ASOA Special Joint Govern- ment Relations Session featuring House Majority Leader Kevin McCarthy (R-CA) was a celebration for the ASCRS domes- tic members who contributed to eyePAC in 2014 and 2015. The event gave attendees a chance to enjoy the Attendees 'get in the game' at 2015 eyePAC reception $45,000 they collectively raised to support eyePAC's efforts. Guests enjoyed refreshments in the Padres Hall of Fame Bar and Grill while watching the championship game of the California Interscholastic Federation high school baseball tournament. Petco Park staff gave guests private tours of the stadium, including the press box and visitors' clubhouse. Guests even had the chance to hit a few pitches in the Padres' visitors batting cages. "It's a fantastic venue, and it's a way to thank all the people who have donated to eyePAC, and it's fortuitous that there happens to be a championship high school game going on today," said Brock K. Bakewell, MD, Tucson, Ariz., chair of the ASCRS Government Relations Committee. The event is a great way to thank everyone who has partici- pated in eyePAC, Dr. Bakewell said, which is a critical part of ASCRS advocacy efforts. "I wish more people would jump onboard and help us out because that's how we get in the door to speak with legislators," he said. "We always need to advocate for organized medicine and ophthal- mology in particular. Even though we've gotten the SGR fixed and the elimination of the 10- and 90-day global periods rescinded, there's still going to be a lot of legislative and regulatory issues that we'll want to influence in the future, so that's why we need to maintain a strong PAC." EW Editors' note: Dr. Bakewell has no financial interests related to his comments. by Lauren Lipuma EyeWorld Staff Writer

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