Xibrom

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 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 reactions were reported in 2 to 7% of patients.

Post-Marketing Experience

The following reactions have been identified during 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 reactions, 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].

Read the entire FDA prescribing information for Xibrom (Bromfenac Ophthalmic Solution )

• Ista Pharmaceuticals, Inc.

Before taking Xibrom, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a sulfa allergy
• have had an allergic reaction to this medication before, to any other NSAID, or to aspirin (Ecotrin)
• have eye defects, damage, or dysfunction
• have rheumatoid arthritis
• have or have had other recent ocular surgeries
• have diabetes
• take blood thinners
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Contraindications

• Known hypersensitivity to bromfenac sodium or any ingredient in the formulation.1

Warnings/Precautions

Warnings

May inhibit platelet aggregation and prolong bleeding time.1

May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.1

Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1

Sensitivity Reactions

Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.1 Use with caution in patients with history of hypersensitivity to these drugs.1

Formulation contains sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.1

General Precautions

May slow or delay wound healing.1 (See Specific Drugs under Interactions.)

Use may result in keratitis.1 In some susceptible patients, continued use may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation; these events may be sight-threatening.1 If manifestations of corneal epithelial breakdown occur, discontinue therapy immediately and monitor for corneal health.1

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 developing adverse corneal effects that may become sight-threatening.1 Use with caution in these patients.1

Use >24 hours prior to surgery or use beyond 14 days postoperatively may precipitate or exacerbate adverse corneal effects.1

Specific Populations

Category C.1

Avoid use in late pregnancy (i.e., third trimester) because of known effects on the fetal cardiovascular system (possible premature closure of the ductus arteriosus).1 2

Not known whether distributed into milk following ophthalmic administration.2 Use with caution.1

Safety and efficacy not established in children <18 years of age.1

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Abnormal ocular sensation, conjunctival hyperemia, ocular redness or irritation (e.g., pruritus, burning, stinging, pain), headache, iritis.1

No formal drug interaction studies to date.3

Specific Drugs

• Risk of ocular bleeding.1 Risk of anaphylactoid and other sensitivity reactions.1

• Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic solution with common bacteria that can cause ocular infections.2

• Importance of removing contact lenses before administration.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Risk of use during late pregnancy.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Bromfenac ophthalmic (eye) solution is used to treat pain or swelling of the eye following cataract surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).

This medicine is available only with your doctor's prescription.

Xibrom ophthalmic solution is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

Use Xibrom exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medication for more than the number of days your doctor has recommended. Using a steroid eye drop too long can increase your risk of serious side effects that may damage your vision.

Do not use this medication while wearing contact lenses. Xibrom may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using this medicine before putting in your contact lenses.

Xibrom is usually given as 1 drop in each affected eye twice daily for 14 days. You will use the first dose 24 hours after your surgery.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the Xibrom eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the Xibrom eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Applies to bromfenac ophthalmic: ophthalmic solution

Along with its needed effects, bromfenac ophthalmic (the active ingredient contained in Xibrom) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bromfenac ophthalmic:

• Blurred vision
• change in color vision
• decreased vision or other changes in vision
• difficulty seeing at night
• eye pain
• red, sore eyes
• sensitivity to light
• tearing

Some side effects of bromfenac ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal sensation in the eye
• burning or stinging of the eye
• feeling of having something in the eye
• headache
• itching of the eyes