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MIRVASO

Rosacea Redness

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IMPORTANT SAFETY
INFORMATION

Getting the Best Results With MIRVASO Gel

How to Apply MIRVASO Gel

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What to Expect From MIRVASO Gel

For most patients, the MIRVASO Gel effect is powerful.
Skin that has been red for days, months, or even years
may suddenly look "normal" again. But remember:

MIRVASO Gel is not a cure for rosacea
Your redness will return after the effect of the medication wears off

Some patients have reported that their redness returned worse than it appeared before
This could be due to exposure to triggers or it may simply be a return to your natural complexion, which may be alarming after seeing yourself without the usual redness. Common triggers include: spicy food; stress and anxiety; hot drinks, such as coffee and tea; alcohol, such as red wine; physical activity, such as exercise; sun exposure; extreme hot or cold environments; and certain skin-care products. Avoid your triggers, even while you are using MIRVASO Gel

Tell your doctor about side effects
In clinical trials, about 10% of subjects reported worsening of redness while using MIRVASO Gel. In every case this side effect was temporary and went away on its own. However, if you are concerned that you may be experiencing a side effect while using MIRVASO Gel, speak to your physician or dermatologist right away


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.

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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You answered yes to questions.

Your facial redness could be related to rosacea.
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.

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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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