NOV 2016

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/743667

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Page 102 of 102

INDICATIONS AND USAGE SIMBRINZA ® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fi xed 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 fi ve (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 specifi cally studied in these patients and is not recommended. 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. 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, dys- geusia (bad taste), dry mouth, and eye allergy. Adverse reaction rates with SIMBRINZA ® Suspension were comparable to those of the individual components. Treatment discontinu- ation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA ® Suspension patients. 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. References: 1. Data on fi le, 2014. 2. SIMBRINZA ® Suspension Package Insert. 24-hour IOP-lowering coverage, including the night — nocturnal effi cacy established through an 8 AM time point 2 © 2016 Novartis 4/16 US-SMB-16-E-1229 Aim for Target IOP Consider Adding SIMBRINZA ® Suspension to a PGA SIMBRINZA ® Suspension should be taken at least fi ve (5) minutes apart from other topical ophthalmic drugs Up to 7.1 mm Hg additional IOP reduction from baseline when added to a PGA 1 5.6 mm Hg* additional mean diurnal IOP lowering observed from baseline when added to a PGA 1 * Treatment difference (mm Hg) and P value at Week 6 was -3.7, P<0.0001. Learn more at myalcon.com/simbrinza For additional information about SIMBRINZA ® Suspension, please refer to the brief summary of the full Prescribing Information on the following page. Treatment Arm 8 AM 10 AM 3 PM 5 PM PGA + SIMBRINZA ® Suspension (N=88) PGA + Vehicle (N=94) Baseline ‡ 24.5 22.9 21.7 21.6 Week 6 19.4 15.8 17.2 15.6 Baseline ‡ 24.3 22.6 21.3 21.2 Week 6 21.5 20.3 20.0 20.1 † Differences (mm Hg) and P values at Week 6 time points between treatment groups were -2.14, P=0.0002; -4.56, P<0.0001; -2.84, P<0.0001; -4.42, P<0.0001. ‡ Baseline (PGA Monotherapy). Baseline || 22.7 Week 6 17.1 Baseline || 22.4 Week 6 20.5 Treatment Arm PGA + SIMBRINZA ® Suspension (N=83) PGA + Vehicle (N=92) § Difference (mm Hg) and P value at Week 6 between treatment groups were -3.44, P<0.0001. || Baseline (PGA Monotherapy). IOP Daily Time Points (mm Hg) 1† Mean Diurnal IOP (mm Hg) 1 § Study Design: A prospective, randomized, multicenter, double-blind, parallel-group study of 189 patients with open-angle glaucoma and/or ocular hypertension receiving treatment with a PGA. PGA treatment consisted of either travoprost, latanoprost, or bimatoprost. Patients in the study were randomized to adjunctive treatment with SIMBRINZA ® Suspension (N=88) or vehicle (N=94). The primary effi cacy endpoint was mean diurnal IOP (IOP averaged over all daily time points) at Week 6 between treatment groups. Key secondary endpoints included IOP at Week 6 for each daily time point (8 AM, 10 AM, 3 PM, and 5 PM) and mean diurnal IOP change from baseline to Week 6 between treatment groups. 1 PGA=prostaglandin analog.

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