Prolensa Drug Information
Generic name: BROMFENAC SODIUM
Uses of Prolensa
® is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. PROLENSA 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 & Administration of Prolensa
Recommended Dosage Apply one drop 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 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.
Side Effects of Prolensa
Clinical Trials 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 practice. The most commonly reported adverse reactions following use of PROLENSA 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.
Warnings & Cautions for Prolensa
- 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 PROLENSA 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 PROLENSA 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 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.
Pregnancy Safety for Prolensa
Pregnancy Risk Summary There are no available data on PROLENSA 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. 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 PROLENSA 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 PROLENSA following ocular administration is unknown. 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).
Pediatric Use of Prolensa
Pediatric Use The safety and effectiveness of PROLENSA have not been established in pediatric patients.
Clinical Studies of Prolensa
Ocular Inflammation and Pain Bromfenac 0.07% QD for the treatment of postoperative
inflammation and reduction of ocular pain was evaluated in two multi-center, randomized, double-masked, parallel-group, and placebo (vehicle)-controlled studies. Patients undergoing cataract surgery self-administered bromfenac 0.07% or vehicle once daily, beginning 1 day prior to surgery, continuing on the morning of surgery and for 14 days after surgery. Complete clearance of ocular inflammation (0 cell and no flare) was assessed on Days 1, 3, 8, and 15 postsurgery using slit lamp biomicroscopy.
The pain score was self-reported. The primary efficacy endpoint was the proportion of subjects who had complete clearance of ocular inflammation by Day 15. In the intent-to-treat analyses from both assessments, complete clearance at Day 8 and Day 15, bromfenac 0.07% was superior to vehicle as shown in the following table. Proportion of Subjects with Cleared Ocular Inflammation (0 cell and no flare) Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI) Study 1 At Day 8 27/112 (24.1%) 7/108 (6.5%)
At Day 15 51/112 (45.5%) 14/108 (13.0%) 32.5 Study 2 At Day
8 33/110 (30.0%) 14/110 (12.7%)
At Day 15 50/110 (45.5%) 30/110 (27.3%) 18.2 Proportion of Subjects Who
Were Pain Free Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI) Study 1 At Day 1 91/112 (81.3%) 47/108 (43.5%)
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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