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MIRVASO

Rosacea Redness

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IMPORTANT SAFETY
INFORMATION

What Is Rosacea?

Rosacea is a common vascular and inflammatory facial skin condition. People with fair skin over age 30 are more likely to get rosacea, but it can affect people of any age, from any background.

Facial redness and rosacea

The facial redness of rosacea, also called erythema (err-uh-thee-ma), is a common rosacea symptom—and may be the only symptom for some people. A 2012 Gallup survey asked 510 people with rosacea which symptoms they were currently experiencing and found that facial redness was by far the most common:

N=510
Facial redness
87%
Facial skin sensitivity to sun
51%
Small, thin, red lines below surface of the skin
42%
Facial burning sensation
40%
Pimples/pustules without blackheads
39%
Eye redness and irritation
31%
Pimples/pustules with blackheads
15%
Enlarged nose or swollen bumps on the nose
14%

You might find that certain things set off your redness. Avoiding known triggers may help you manage your symptoms. Learn about common triggers and rosacea skin care

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.

MIRVASO Cost Reduction Card Program Information

1. This offer is not valid if prescriptions are paid by any state or other federally funded programs, including, but not limited to Medicare or Medicaid, Medigap, VA, DOD or TRICARE®. 2. This card is good for use only with a MIRVASO® (brimonidine) topical gel, 0.33%* prescription at the time the prescription is filled by the pharmacist and dispensed to the patient. 3. Offer good only in the USA at participating retail pharmacies and cannot be redeemed at government-subsidized clinics. 4. Galderma Laboratories, L.P. reserves the right to rescind, revoke, or amend this offer without notice at any time. 5. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. 6. Cash value is 1/100th of 1¢. 7. By using this card, you demonstrate that you understand and agree to comply with the terms and conditions of this offer as set forth on this card. 8. Actual payment for product will depend on individual insurance coverage.

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

Study Designs

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 3.3 mg of brimonidine free base.

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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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