Adjunct to PGA Monotherapy

SIMBRINZA® Suspension reduced IOP in clinical trials as monotherapy1,2

Up to nearly 9 mm Hg mean IOP reduction from baseline at month 3 as monotherapy1,2

SIMBRINZA® Suspension provides 24-hour IOP-lowering coverage3

Established through an 8 AM time point

Up to nearly 35% mean IOP reduction from baseline at month 3 as monotherapy1,2

STUDY DESIGN1-3

Intent-to-treat data from two 3-month clinical studies (N=649; N=679). Patients with ocular hypertension or open-angle glaucoma with elevated IOP were given SIMBRINZA® Suspension 3 times a day (tid); brinzolamide ophthalmic suspension, 1%, 3 times a day (tid); or brimonidine tartrate ophthalmic solution, 0.2%, 3 times a day (tid). Patients’ mean IOPs at baseline were 21 to 36 mm Hg. Dosing times were at 8 AM, 3 PM, and 10 PM. For study 1 at baseline: SIMBRINZA® Suspension, n=209; brinzolamide, n=224; brimonidine, n=216. For study 2 at baseline: SIMBRINZA® Suspension, n=218; brinzolamide, n=229; brimonidine, n=232. Study 1 compared the IOP-lowering efficacy of SIMBRINZA® Suspension with the efficacy of its components brinzolamide and brimonidine. Primary end point for study 1 was the mean IOP at the 3-month visit at all time points: 8 AM, 10 AM, 3 PM, and 5 PM. Study 2 assessed the superiority of the IOP-lowering efficacy of SIMBRINZA® Suspension vs brinzolamide alone and brimonidine alone. Primary end point for study 2 was the mean IOP at 3 months at all time points: 8 AM, 10 AM, 3 PM, and 5 PM.

References: 1. Katz G, DuBiner H, Samples J, Void S, Sall K. Three-month randomized trial of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%. JAMA Ophthalmol. 2013;131(6):724-730. doi:10.1001/jamaophthalmol.2013.188. 2. Nguyen QH, McMenemy MG, Realini T, Whitson JT, Goode SM. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%. J Ocul Pharmacol Ther. 2013;29(3):290-297. 3. SIMBRINZA® Suspension [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; 2015.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination indicated in the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Dosage and Administration

The recommended dose is one drop of SIMBRINZA® Suspension in the affected eye(s) three times daily. Shake well before use. SIMBRINZA® Suspension may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

IMPORTANT SAFETY INFORMATION

Contraindications

SIMBRINZA® Suspension is contraindicated in patients who are hypersensitive to any component of this product and neonates and infants under the age of 2 years.

Warnings and Precautions

Sulfonamide Hypersensitivity Reactions—Brinzolamide is a sulfonamide, and although administered topically, is absorbed systemically. Sulfonamide attributable adverse reactions may occur. Fatalities have occurred due to severe reactions to sulfonamides. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.

Corneal Endothelium—There is an increased potential for developing corneal edema in patients with low endothelial cell counts.

Severe Hepatic or Renal Impairment (CrCl <30 mL/min)—SIMBRINZA® Suspension has not been specifically studied in these patients and is not recommended.

Acute Angle-Closure Glaucoma—The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. SIMBRINZA® Suspension has not been studied in patients with acute angle-closure glaucoma.

Contact Lens Wear—The preservative in SIMBRINZA® Suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of SIMBRINZA® Suspension but may be reinserted 15 minutes after instillation.

Severe Cardiovascular Disease—Brimonidine tartrate, a component of SIMBRINZA® Suspension, had a less than 5% mean decrease in blood pressure 2 hours after dosing in clinical studies; caution should be exercised in treating patients with severe cardiovascular disease.

Potentiation of Vascular Insufficiency—Brimonidine tartrate, a component of SIMBRINZA® Suspension, may potentiate syndromes associated with vascular insufficiency. It should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

Contamination of Topical Ophthalmic Products After Use—There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers have been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

Adverse Reactions
SIMBRINZA® Suspension

In two clinical trials of 3 months’ duration with SIMBRINZA® Suspension, the most frequent reactions associated with its use occurring in approximately 3-5% of patients in descending order of incidence included: blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy. Adverse reaction rates with SIMBRINZA® Suspension were comparable to those of the individual components. Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA® Suspension patients.

Brinzolamide 1%

In clinical studies of brinzolamide ophthalmic suspension 1%, the most frequently reported adverse events reported in 5-10% of patients were blurred vision and bitter, sour, or unusual taste. Adverse events occurring in 1-5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus, and rhinitis.

Brimonidine Tartrate 0.2%

In clinical studies of brimonidine tartrate 0.2%, adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.

Events occurring in approximately 3-9% of the subjects, in descending order, included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision, and muscular pain.

Drug Interactions

Consider the following when prescribing SIMBRINZA® Suspension:

Concomitant administration with oral carbonic anhydrase inhibitors is not recommended due to the potential additive effect. Use with high-dose salicylate may result in acid-base and electrolyte alterations. Use with CNS depressants may result in an additive or potentiating effect. Use with antihypertensives/cardiac glycosides may result in additive or potentiating effect on lowering blood pressure. Use with tricyclic antidepressants may blunt the hypotensive effect of systemic clonidine and it is unknown if use with this class of drugs interferes with IOP lowering. Use with monoamine oxidase inhibitors may result in increased hypotension.

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SIMBRINZA® is a registered trademark of Novartis AG.

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