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MIRVASO

Rosacea Redness

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IMPORTANT SAFETY
INFORMATION

MIRVASO Gel FAQ

In case you were wondering...

Q: What is MIRVASO Gel?

MIRVASO® (brimonidine) topical gel, 0.33%* is formulated especially to treat the persistent (nontransient) facial redness of rosacea in people 18 years and older.

Q: How does MIRVASO Gel work?

MIRVASO Gel is believed to reduce excessive blood flow that's associated with rosacea redness.

Q: How should I apply MIRVASO Gel?

Use the MIRVASO Gel Pump to dispense a pea-sized amount of MIRVASO Gel onto your fingertip. Apply pea-sized amounts to your forehead, chin, nose, and each cheek 1 time each day. See the Instructions for Use in the Prescribing Information.

Q: Can I still wear makeup with MIRVASO Gel?

In clinical studies, subjects were allowed to use makeup after MIRVASO Gel had dried.

Q: Are there any side effects?

Yes. In controlled clinical trials with MIRVASO Gel, the most common side effects that occurred in at least 1% of subjects included redness, flushing, skin burning sensation, and contact dermatitis.

Q: Can I use MIRVASO Gel every day?

Yes, use MIRVASO Gel every day for as long as your doctor prescribes.

Q: Why does my face sometimes seem redder after using MIRVASO Gel?

Some patients have reported a "worsening" of redness after the effect of the medication wears off. This can be caused by a number of factors, including:

Rosacea triggers
Remember to avoid your triggers even when using MIRVASO Gel. Rosacea triggers can make your symptoms worse, even while on medication, so always stay clear of them!

The effect of the medication
For most patients the MIRVASO Gel effect is powerful, and skin that has been red for days, months, or even years will suddenly look "clear" (or "healthy") again. It is important to remember that MIRVASO Gel is not a cure, and after the effect of the medication wears off, your redness will return. Some patients have reported that the redness returned worse, but this could simply be a return of the redness to the same level prior to the medication, which can sometimes be alarming after seeing skin without the redness.

An adverse event
If you experience any side effect that you are concerned about while using MIRVASO Gel, speak to your physician or dermatologist right away.
HOW TO USE MIRVASO Gel

Q: Are there different types of rosacea? Are the treatments different?

There are 4 basic types of rosacea, although they share some of the same symptoms: facial redness, bumps and blemishes, skin thickening, and ocular (eye) rosacea. Your doctor or dermatologist can determine the type of rosacea you have, and can discuss the best treatment option that will help manage your symptoms. MIRVASO Gel is the first and only FDA-approved treatment specifically developed and indicated to treat the persistent facial redness of rosacea.

Learn about an oral treatment for bumps and blemishes

Learn about a topical treatment for bumps and blemishes

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 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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