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About Xibrom

sfgdsfXibrom (bromfenac ophthalmic solution)® 0.09%, the leading prescription topical ophthalmic NSAID in the United States, is the first twice-daily eye drop medication belonging to a group of medications called nonsteroidal anti-inflammatory drugs or NSAIDs. Xibrom is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction.1

Clinical studies have demonstrated that Xibrom ophthalmic solution provides significant relief from inflammation and pain associated with cataract extraction2. Xibrom is a comfortable drop and was well tolerated by patients in clinical trials with only a 1.4% burn and sting rate2. With over 20 million ophthalmic patient uses internationally, the active ingredient in Xibrom has a favorable safety and tolerability record. There is always the potential for side effects, or as clinicians refer to them, adverse events.

"My clinical experience closely mirrors the official FDA phase 3 data for bromfenac. Because of its efficacy and the BID dosing schedule, Xibrom has been my NSAID of choice for my cataract surgery patients."

 

Uday Devgan, MD, FACS3
Devgan Eye Surgery
Los Angeles, Beverly Hills, and Newport Beach, CA



Warnings

XIBROM 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 nonashtmatic people.

 

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

 

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.

 

Precautions General

 

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) 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 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 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.

 

It is recommended that XIBROM ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

 

Adverse Reactions

 

The most commonly reported adverse experiences following use of Xibrom 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.

 

Dosage and Administration

 

One drop of XIBROM ophthalmic solution should be applied to the affected eye(s) two times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

 

 

See full prescribing information

References

  1. Xibrom [physician insert]. ISTA Pharmaceuticals, Inc., Irvine, CA.

  2. Donnenfeld ED, Donnenfeld A. Global experience with Xibrom (bromfenac sodium ophthalmic solution)® 0.09% Study Group. Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation Ophthal 2007;114(9):1653-1662.

  3. Physician is a paid consultant of ISTA Pharmaceuticals, Inc.