Eyeworld

FEB 2013

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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Bromday��� (bromfenac ophthalmic solution) 0.09% HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Bromday (bromfenac ophthalmic solution) 0.09% safely and effectively. See full prescribing information for Bromday. Bromday (bromfenac ophthalmic solution) 0.09% Initial U.S. Approval: 1997 --------------INDICATIONS AND USAGE-------------(NSAID) indicated for the treatment of postoperative patients who have undergone cataract extraction (1). -----------DOSAGE AND ADMINISTRATION----------Instill one drop into the affected eye(s) once daily beginning 1 day prior to surgery, continued on the surgery (2.1). ---------DOSAGE FORMS AND STRENGTHS--------Topical ophthalmic solution: bromfenac 0.09% (3) 'U--13&4$3*#*/(*/'ORMATION: $ONTENTS* 1.*/%*$ATIONS AND USA(& 2. DOSA(& AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Use with Other Topical Ophthalmic Medications 3. DOSA(&'03.4 "/%453&/(5)4 .$0/53"*/%*$ATIONS 5. W"3/*/(4 "/%13&$AUTIONS 5.2 Slow or Delayed Healing 5.3 PPUFOUJBMGPS$SPTT4FOTJUJWJUZ *ODSFBTFE#MFFEJOH Time ,FSBUJUJTBOE$Prneal Reactions $POUBDU-FOT Wear 6. ADVERSE REA$5*0/4 $MJOJDBM Trial Experience 6.2 Post-Marketing Experience 8.64&*/41&$*'*$1016-ATIONS 8.1 Pregnancy FULL PRESCRIBING INFORMATION 1. INDICATIONS AND USAGE Bromday (bromfenac ophthalmic solution) 0.09% is indicated for the treatment of postoperative patients who have undergone cataract surgery. 2. DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing patients who have undergone cataract extraction, one drop of Bromday ophthalmic solution should be applied to the affected eye(s) once daily beginning 1 day prior to cataract surgery, continued on the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications Bromday ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart. 3. DOSAGE FORMS AND STRENGTHS Topical ophthalmic solution: bromfenac 0.09%. 4. CONTRAINDICATIONS None. 5. WARNINGS AND PRECAUTIONS allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. general population is unknown and probably asthmatic than in non-asthmatic people. 5.2 Slow or Delayed Healing (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing.$PODPNJUBOUVTFPGUPQJDBM/4"*%TBOE topical steroids may increase the potential for healing problems. 5.3 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to -----------WARNINGS AND PRECAUTIONS----------r4Mow or Delayed Healing (5.2) rPotential for cross-sensitivity (5.3) r*ODSFBTFCMFFEJOHPGPDVMBSUJTTVFT r$Prneal effects including keratitis (5.5) r$POUBDU-FOT Wear (5.6) ------------------ADVERSE REACTIONS-----------------The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) (6.1). To report SUSPECTED ADVERSE REACTIONS, contact ISTA Pharmaceuticals, Inc. at 1-877-788-2020, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION Revised: 8/2011 8.3 Nursing Mothers Pediatric Use (FSJBUSJD6TF 11.%&4$3*15*0/ 12.$-*/*$"-1)"3.A$0-0(: 12.1 Mechanism of Action 12.3 Pharmacokinetics 13./0/$-*/*$"- T09*$0-0(: $BSDJOPgenesis, Mutagenesis and ImpairNFOUPG'Frtility .$-*/*$"-456%*&4 16. HO84611-*&%4TORA(& "/%)"/%-*/( 17. PA5*&/5$06/4&-*/(*/'03.ATION 17.1 Slowed or Delayed Healing 17.2 Sterility of Dropper Tip $PODPNJUBOU6TFPG$POUBDU-FOTFT $PODPNJUBOU Topical Ocular Therapy *Sections or subsections omitted from the full prescribing information are not listed. acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.4 Increased Bleeding Time With some NSAIDs, 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 Bromday 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 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 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 suggFTUTUIBUVTFNPSFUIBOIPVSTQSJPSUP surgery or use beyPOEEays post surgery may increase patient risk for the occurrence and severity of corneal adverse events. 5.6 Contact Lens Wear Bromday should not be administered while wearing contact lenses 6. ADVERSE REACTIONS 6.1 Clinical Trial Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients. 6.2 Post-Marketing Experience post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [see Warnings and Precautions (5)] 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/ day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. 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 potential risk to the fetus. Nonteratogenic Effects: Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Bromday ophthalmic solution during late pregnancy should be avoided. 8.3 Nursing Mothers $BVUJPOTIPVMECFFYFSDJTFEwhen Bromday is administered to a nursing woman. 8.4 Pediatric Use age of 18 have not been established. 8.5 Geriatric Use age and older compared to younger adult patients. 11. DESCRIPTION Bromday (bromfenac ophthalmic solution) 0.09% drug (NSAID) for ophthalmic use.&BDIN-PG Bromday contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as TPEJVNBNJOPCSPNPCFO[oyl) phenylacetate sesquihydrate, with an empirical formula of $15H11BrNNaO3 r 1��H2O. The structural formula for bromfenac sodium is: Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Bromday ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of Bromday ophthalmic solution is approximately 300 mOsmol/kg. Each mL of Bromday ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035% Preservative: benzalkonium chloride (0.05 mg/m-) Inactives: boric acid, disodium edetate (0.2 mg/ N- ,QPMZTPSCBUFNHN- , povidone (20 NHN- , sodium hydroxide to adjust pH and water for injection, USP. 12. CLINICAL PHARMACOLOGY 12.1 Mechanism of Action mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. 12.3 Pharmacokinetics The plasma concentration of bromfenac following ocular administration of 0.09% Bromday (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose of one drop to the eyFNH BOE1,JOGPrmation from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit humans. 13. NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility -POHUFrm carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (900 times the recommended human ophthalmic dose [RHOD] of 1.67 mcg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5 mg/kg/day (7500 times RHOD), respectively 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 (1300 BOEUJNFT3)0D, respectively). 14. CLINICAL STUDIES cataract surgery $MJOJDBMFG��DBDZXBTFWBMVBUFEJOUISFFSBOEPNJ[FE double-masked, placebo-controlled trials in which subjects requiring cataract surgery were assigned to Bromday or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing GPSEays. The primary endpoint was clearing of "OBEEJUJPOBMFG��DBDZ endpoint was the number of patients who were pain free on day 1 after cataract surgery. In 2 of the 3 studies, Bromday ophthalmic solution incidence of subjects that were pain free at day 1 post cataract surgery (83-89% vs. 51-71%). 16. HOW SUPPLIED/STORAGE AND HANDLING Bromday (bromfenac ophthalmic solution) 0.09% is supplied in a wIJUF-%1&QMBTUJDTRVFF[FCPUUMF XJUIBNN-%1&white dropper-tip and 15 mm polypropylene gray cap as follows: N-JON-DPOUBJOFS/%$ N-JON-DPOUBJOFSBTB5XJO1BDLCPUUMFT /%$ STORAGE 4UPSFBU��m��$��m��' 17. PATIENT COUNSELING INFORMATION 17.1 Slowed or Delayed Healing Patients should be advised of the possibility that slow or delayed healing may occur while using NSAIDs. 17.2 Sterility of Dropper Tip Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents. 17.3 Concomitant Use of Contact Lenses $POUBDUMFOTFTTIPVMEOPUCFworn during the use of this product. 17.4 Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart Rx Only ��ISTA Pharmaceuticals��, Inc. Manufactured for: ISTA Pharmaceuticals, Inc. Irvine,$" #Z#BVTDI-PNC*ODPSQPSBUFE Tampa,'- Under license from: Senju PharNBDFVUJDBMT$P,-UE Osaka,+BQBO BQD721-8/11 �� and ��� marks owned by ISTA Pharmaceuticals, Inc.

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