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MIRVASO

Rosacea Redness

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IMPORTANT SAFETY
INFORMATION

MIRVASO Gel—A Safe and Effective Way
to Treat the Facial Redness of Rosacea

Fast results that last up to 12 hours

Get ready for real redness relief: MIRVASO® (brimonidine) topical gel, 0.33%* is the first and only FDA-approved medication developed and indicated for the persistent (nontransient) facial redness of rosacea. MIRVASO Gel has been proven to continue to give consistent results, month after month.

MIRVASO Gel Key Facts

MIRVASO Gel is a temporary treatment for facial redness
MIRVASO Gel may dramatically reduce your symptoms, but it won't prevent or cure facial redness. Your redness will return after the effect of MIRVASO Gel wears off.

MIRVASO Gel is available in the MIRVASO Gel Pump
The delivery system of the MIRVASO Gel pump gives a consistent dose at each use.

Exposure to triggers could make your symptoms worse
Avoid your triggers, even if you are using MIRVASO Gel as directed.

Some patients have reported a "worsening" of redness several hours after using MIRVASO Gel
A small percentage of patients in clinical studies reported that their facial redness returned worse than it appeared before using MIRVASO Gel. This could be caused by a return of the redness to the same level it was prior to using MIRVASO Gel, which can be concerning, especially after seeing "healthy" colored skin. Although this return of redness should go away with additional treatment, if you experience discomfort or have any concerns or questions about using MIRVASO Gel, contact your doctor.
HOW TO USE MIRVASO GEL

In clinical studies with MIRVASO Gel, the primary endpoint showed rosacea redness was reduced for up to 12 hours for 22% of study participants (versus 9% of people using a gel with no active ingredient [vehicle gel]). The secondary endpoint showed redness was visibly reduced in as little as 30 minutes for 28% of participants (versus 6% of people using the vehicle gel).

MIRVASO Gel has been developed and clinically evaluated specifically for the treatment of the redness associated with a common skin condition called rosacea. Still not sure if MIRVASO Gel could be an option for treating your facial redness?

Answer a few questions to see if what you’re experiencing may be related to rosacea.

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.

The long-term safety and efficacy of MIRVASO Gel was evaluated in a 1-year, open-label, non-comparative study in 276 subjects with moderate to severe facial redness of rosacea who used MIRVASO Gel once daily for at least 12 months.

The safety and efficacy of MIRVASO Gel 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 Gel 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.

MIRVASO Study Description

MIRVASO was tested in 2 medical studies with 553 people aged 18 and older. Half of study participants used MIRVASO and the other half used a gel with no active ingredient for 29 days. Patients and researchers were asked to grade the improvement they saw at hours 3, 6, 9, and 12. On day 29 of the trials, 2-grade improvement was observed with MIRVASO versus inactive gel at Hour 3 (28% vs 10%), at Hour 6 (28% vs 9%), at Hour 9 (22% vs 10%), and at Hour 12 (22% vs 9%). At 30 minutes on day 1, 28% of patients using MIRVASO experienced 1-grade improvement of facial redness versus 6% for people using the inactive gel. Individual results with MIRVASO may vary.

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Your facial redness could be related to rosacea.
To know for sure, visit your doctor and discuss your symptoms.


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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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