MIRVASO Topical Gel was well-tolerated in clinical trials1
The safety and efficacy of MIRVASO® (brimonidine) topical gel, 0.33%* was evaluated in 2 identical 8-week randomized,
Adverse reactions reported in MIRVASO Topical Gel clinical trials by ≥1% of study participants treated for 29 days1:
The safety and efficacy of MIRVASO Topical Gel was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 patients aged 18 years and older. Patients were randomized 1:1 to receive either MIRVASO Topical Gel or vehicle gel once daily for 4 weeks.2
Additionally, in a 52-week safety study, MIRVASO Topical Gel was demonstrated to be safe and effective.3 The most common adverse events (≥4% of study participants) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).3
- MIRVASO Topical Gel [prescribing information]. Galderma Laboratories, L.P.: Fort Worth, TX; 2013.
- Fowler J Jr, Jackson JM, Moore A, et al; Brimonidine Phase III Study Group. Efficacy and safety of once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12(6):650-656.
- Data on file. Galderma Laboratories, L.P.
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.
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To know for sure, visit your doctor and discuss your symptoms.
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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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