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MIRVASO

Rosacea Redness

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IMPORTANT SAFETY
INFORMATION

Skin Care & Triggers

Get your rosacea redness under control by taking control. In addition to treatment, a combination of rosacea-smart skin care and avoiding your triggers can help you manage your facial redness. Talk to your dermatologist about creating a skin care regimen that's right for you. In the meantime, here are some tips to put you on the right track.

Think gentle when it comes to your daily skin care regimen

The skin of rosacea patients tends to be sensitive to certain skin care products and cosmetics, especially ones with alcohol or fragrances. And harsh cleansers like exfoliators or scrubs can irritate your skin and make redness flare up.

Avoid potential irritants

Cosmetics, creams, and cleansers with added fragrances
Harsh scrubs, toners, or astringents
Waterproof products that require scrubbing to remove
Products with alcohol, witch hazel, menthol, peppermint, or eucalyptus oil

If you’re not sure if an ingredient may set off your symptoms, test a little bit of the product on a small area on your neck first.

Know your triggers

Triggers are different for everyone, but sun exposure, very hot or very cold weather, and spicy foods are a few of the worst culprits.

Sun exposure

A National Rosacea Society survey identified sun as the #1 rosacea trigger. Minimizing exposure to sun by wearing protective clothing or applying a sunscreen with an SPF of 15 or higher may help.

Heat

Hot showers, hot weather, hot beverages...try to keep it cool to avoid redness flare-ups.

Cold

Winter wind and cold air are big triggers for many people. Protect your face when you have to spend time in the cold.

Exercise

Workouts are great for the body, but they’re also great at heating up your facial redness. When you're exercising—indoors or out—try to stay cool.

Food

Red wine, spicy foods, hot beverages, and foods such as soy sauce, vinegar, and cheese could set off redness. To identify your trouble foods, pay attention to how your skin reacts after you eat a suspected trigger.

Stress

Worry and tension can bring on rosacea redness, which can bring on more stress! Find ways to manage your stress and make sure you’re getting proper rest and eating right.

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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