PROLENSA Powered for Penetration

PROLENSA Powered for Penetration

PROLENSA (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

IMPORTANT RISK INFORMATION ABOUT PROLENSA

Indications and Usage

PROLENSA (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Dosage and Administration

Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days post surgery.

Warnings and Precautions

  • Sulfite allergic reactions — PROLENSA contains sodium sulfite, which may cause allergic-type reactions, including anaphylactic shock 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 nonasthmatic people
  • Slow or delayed healing — All topical 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
  • Potential for cross-sensitivity — Caution should be used when treating individuals who have previously exhibited sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs
  • Increased bleeding time — There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use PROLENSA with caution in patients with known bleeding tendencies or who are receiving other medications that may prolong bleeding time
  • Keratitis and corneal reactions — Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, dry eye disease), 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. Postmarketing experience suggests that use of topical NSAIDs more than 24 hours prior to surgery or use 14 days post surgery may increase a patient’s risk for the occurrence and severity of corneal adverse events. Topical NSAIDs should be used with caution in these patients
  • Contact lens wear — PROLENSA should not be instilled while wearing contact lenses. Lenses may be inserted 10 minutes following administration of PROLENSA

Adverse Reactions

The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.

References: 1. PROLENSA™ Prescribing Information, April 2013. 2. Data on file, Bausch & Lomb Incorporated.