Important Safety Information
Indication: MIRVASO® (brimonidine) topical gel, 0.33%* is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Adverse Events: In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis. Warnings/Precautions: MIRVASO Topical Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. MIRVASO Topical Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of MIRVASO Topical Gel by children have been reported. Keep MIRVASO Topical Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You answered yes to questions.
To know for sure, visit your doctor and discuss your symptoms.
Your answers don't provide enough information to tell you if you could have the
facial redness of rosacea. Talk to your doctor about your symptoms.
Two 4-week pivotal studies
The safety and efficacy of MIRVASO® (brimonidine) topical gel, 0.33%* was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 patients aged 18 years and older. Study participants were randomized 1:1 to receive either MIRVASO or vehicle gel once daily for 4 weeks. The primary endpoint for both studies was 2-grade composite success at hours 3, 6, 9, and 12 on day 29. The secondary endpoint was 1-grade composite success at 30 minutes on day 1. Composite success was defined as improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.1
Long-term, open-label study
The long-term safety and efficacy of MIRVASO was studied in a 52-week, multicenter, open-label, non-comparative study with 449 patients with moderate to severe facial erythema of rosacea. The primary objective of the study was to evaluate the long-term safety of MIRVASO applied once daily for up to 12 months. The secondary objective of the study was to evaluate the long-term efficacy of MIRVASO applied once daily for up to 12 months.2
*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to
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You are encouraged to report negative side effects of prescription drugs to the FDA.
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