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,
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
|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
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.
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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