MIRVASO

Efficacy

Tolerability

Patient Savings

MIRVASO is the first and only FDA-approved topical treatment specifically developed and indicated for the persistent facial erythema of rosacea1

Primary endpoint: 2-grade improvement on both the Clinical Erythema Assessment and Patient Self-Assessment scales at hours 3, 6, 9, and 12 on day 29.1 At 12 hours on day 29, a 2-grade improvement of facial erythema was reported in 22% of study participants using MIRVASO® (brimonidine) topical gel, 0.33%* compared to 9% of participants using vehicle gel (P<.001).2,3†


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  1. MIRVASO Gel [prescribing information]. Galderma Laboratories, L.P.: Fort Worth, TX; 2013.
  2. 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.
  3. 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 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 Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of Mirvaso Gel by children have been reported. Keep Mirvaso 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.

*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

Pooled data analysis from two 4-week, phase 3, multicenter, randomized, controlled clinical studies evaluating the efficacy and safety of MIRVASO for the treatment of the facial erythema of rosacea in subjects 18 years of age and older.

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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 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 Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of Mirvaso Gel by children have been reported. Keep Mirvaso 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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