Mirvaso
(Brimonidine Tartrate)Dosage & Administration
Apply a pea-sized amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips.
Wash hands after applying MIRVASO topical gel.
MIRVASO topical gel is for topical use only and not for oral, ophthalmic, or intravaginal use.
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Mirvaso Prescribing Information
MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.
Apply a pea-sized amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips.
Wash hands after applying MIRVASO topical gel.
MIRVASO topical gel is for topical use only and not for oral, ophthalmic, or intravaginal use.
MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.
MIRVASO topical gel is contratindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticaria, and contact dermatitis [
Allergic contact dermatitis was reported in the clinical trials for MIRVASO topical gel [
Events reported post marketing with the use of MIRVASO topical gel include angioedema, throat tightening, tongue swelling, and urticaria, [
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical trials, 1210 subjects were exposed to MIRVASO topical gel. A total of 833 subjects were treated for persistent (nontransient) erythema associated with rosacea, and 330 of those were treated once daily for 29 days in vehicle-controlled trials.
Adverse reactions that occurred in at least 1% of subjects treated with MIRVASO topical gel once daily for 29 days and for which the rate for MIRVASO topical gel exceeded the rate for vehicle are presented in Table 1.
Preferred Term | MIRVASO Topical Gel (N=330) n (%) | Vehicle Gel (N=331) n (%) |
Subjects with at least one adverse reaction, Number (%) of Subjects | 109 (33) | 91 (28) |
| Erythema | 12 (4%) | 3 (1%) |
| Flushing | 9 (3%) | 0 |
| Skin burning sensation | 5 (2%) | 2 (1%) |
| Dermatitis contact | 3 (1%) | 1 (<1%) |
| Dermatitis | 3 (1%) | 1 (<1%) |
| Skin warm | 3 (1%) | 0 |
| Paraesthesia | 2 (1%) | 1 (<1%) |
| Acne | 2 (1%) | 1 (<1%) |
| Pain of skin | 2 (1%) | 0 |
| Vision blurred | 2 (1%) | 0 |
| Nasal congestion | 2 (1%) | 0 |
An open-label study of MIRVASO topical gel when applied once daily for up to one year was conducted in subjects with persistent (nontransient) facial erythema of rosacea. Subjects were allowed to use other rosacea therapies. A total of 276 subjects applied MIRVASO topical gel for at least one year. The most common adverse events (
Allergic contact dermatitis to MIRVASO topical gel was reported in approximately 1% of subjects across the clinical development program. Two subjects underwent patch testing with individual product ingredients. One subject was found to be sensitive to brimonidine tartrate, and one subject was sensitive to phenoxyethanol (a preservative).
The following adverse reactions have been identified during post-approval use of MIRVASO topical gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
The following adverse drug reactions are discussed in greater detail in other sections of the label:
- Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists [see Warnings and Precautions (])5.4 Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists
Postmarketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported. Some cases required hospitalization. Some cases involved application of MIRVASO topical gel in unapproved dosing regimens and for unapproved indications, including the application of MIRVASO topical gel following laser procedures.
Avoid applying MIRVASO topical gel to irritated skin or open wounds.
- Local Vasomotor Adverse Reactions [see Warnings and Precautions (])5.5 Local Vasomotor Adverse ReactionsErythema
Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema. Some subjects in the clinical trials reported a rebound phenomenon, where erythema was reported to return worse compared to the severity at baseline.
Erythema appeared to resolve after discontinuation of MIRVASO topical gel
.[seeAdverse Reactions]. Flushing appeared to resolve after discontinuation of MIRVASO topical gel.From postmarketing reports, some patients have experienced increased frequency of flushing and/or increased depth of
erythema with the flushing. Additionally, some patients reported new onset of flushing.
Pallor and Excessive WhiteningFrom postmarketing reports, some patients have experienced pallor or excessive whitening at or outside the application site following treatment with MIRVASO topical gel.
- Hypersensitivity [see Warnings and Precautions (])5.6 Hypersensitivity
Allergic contact dermatitis was reported in the clinical trials for MIRVASO topical gel [
see Adverse Reactions].Events reported post marketing with the use of MIRVASO topical gel include angioedema, throat tightening, tongue swelling, and urticaria, [
see Adverse Reactions]. Institute appropriate therapy and discontinue MIRVASO topical gel, if clinically significant hypersensitivity reaction occurs.
MIRVASO (brimonidine) topical gel, 0.33% contains brimonidine tartrate, an alpha adrenergic agonist.
The molecular formula of brimonidine tartrate is C
11H
10BrN
5• C
4H
6O
6. It has the following structural formula:
Chemically, brimonidine tartrate is 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Brimonidine tartrate has a molecular weight of 442.24 and appears as white to slightly yellowish powder.
Each gram of MIRVASO (brimonidine) topical gel, 0.33% contains 5 mg of the active ingredient brimonidine tartrate (equivalent to 3.3 mg of brimonidine free base), in a white to light yellow opaque gel composed of the inactive ingredients carbomer homopolymer type B, glycerin, methylparaben, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, and titanium dioxide.