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MIRVASO Topical Gel FAQ
In case you were wondering...
Q: What is MIRVASO Topical 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 Topical Gel work?MIRVASO Topical Gel is believed to reduce excessive blood flow that's associated with rosacea redness.
Q: How should I apply MIRVASO Topical Gel?Use the MIRVASO Topical Gel Pump to dispense a pea-sized amount of MIRVASO Topical 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 Topical Gel?In clinical studies, subjects were allowed to use makeup after MIRVASO Topical Gel had dried.
Q: Are there any side effects?Yes. In controlled clinical trials with MIRVASO Topical 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 Topical Gel every day?Yes, use MIRVASO Topical Gel every day for as long as your doctor prescribes.
Q: Why does my face sometimes seem redder after using MIRVASO Topical 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 Topical Gel. Rosacea triggers can make your symptoms worse, even while on medication, so always stay clear of them! |
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The effect of the medication |
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 Topical Gel is the first FDA-approved treatment specifically developed and indicated to treat the persistent facial redness of 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 Topical 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 Topical Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of MIRVASO Topical Gel by children have been reported. Keep MIRVASO Topical 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.
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Your facial redness could be related to rosacea.
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facial redness of rosacea. Talk to your doctor about your symptoms.
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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
PROGRAM DETAILS:
The Galderma® CareConnect Program is brought to you by Galderma Laboratories, L.P. The Patient Savings Card provides savings on out‑of‑pocket expenses for up to a 30‑day supply of included Galderma products, as described below. If you have valid prescriptions for more than one Galderma product, the copay expense and savings apply to each product. You may use the Patient Savings Card once every 30 days, depending on when you last received a 30‑day supply of each Galderma product. Use of the Patient Savings Card does not obligate you to use or to continue using any Galderma product. You may use the Patient Savings Card at any participating pharmacy located in the United States.
The Galderma CareConnect Program Patient Savings Card may not be combined with any savings, discount, free trial, or other similar offer for the same prescription. The Patient Savings Card is not transferable and is void if reproduced. The Patient Savings Card is not health insurance. Limit one (1) Patient Savings Card per patient. The Galderma CareConnect Program Patient Savings Card has no cash value and will not be accepted outside of participating pharmacies in the United States. Please visit Galderma’s website for our privacy practices. Galderma reserves the right to revoke or amend this offer without notice at any time and to deny payment for noncompliance with the terms of this offer. This offer expires December 31, 2016, unless this offer is earlier terminated by Galderma.
Use of this Patient Savings Card is subject to applicable state and federal law, and is void where prohibited by law, rule or regulation. In the event an AB rated generic equivalent product becomes available for one of the Galderma products covered by this Patient Savings Card, this offer will become void in Massachusetts with respect to that Galderma product.
You are encouraged to report negative side effects of prescription drugs to the FDA.
By using the Galderma CareConnect Program Patient Savings Card, you acknowledge that you currently meet the following eligibility criteria:
- You have a valid prescription for the Galderma product your copay and the savings apply to;
- You have no insurance or are subject to a private insurance copay requirement for your prescription;
- You are not enrolled in Medicare Part D, Medicaid, Medigap, VA, DOD, Tricare, or any other government-run or government sponsored health care program with a pharmacy benefit;
- You are at least 18 years old; and
- You reside in the United States.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.