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.
2 DOSAGE AND ADMINISTRATION
Apply a pea-size 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 not for oral, ophthalmic, or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS
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.
5 WARNINGS AND PRECAUTIONS
5.1 Potentiation of Vascular Insufficiency
MIRVASO topical gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome.
5.2 Severe Cardiovascular Disease
Alpha-2 adrenergic agonists can lower blood pressure. MIRVASO topical gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.
5.3 Serious Adverse Reactions Following Ingestion of MIRVASO topical gel
Two young children of a subject in a clinical trial experienced serious adverse reactions following accidental ingestion of MIRVASO topical gel. Adverse reactions experienced by one or both children included lethargy, respiratory distress with apneic episodes (requiring intubation), sinus bradycardia, confusion, psychomotor hyperactivity, and diaphoresis. Both children were hospitalized overnight and discharged the following day without sequelae.
Keep MIRVASO topical gel out of reach of children.
5.4 Erythema and Flushing
Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema or flushing.
The effect of MIRVASO topical gel may begin to diminish hours after application. For some subjects in the clinical trials, erythema was reported to return worse compared to the severity at baseline [see Adverse Reactions (6)].
Intermittent flushing occurred in some subjects treated with MIRVASO topical gel. The onset of flushing relative to application of MIRVASO topical gel varied, ranging from approximately 30 minutes to several hours [see Adverse Reactions (6)].
Erythema and flushing appeared to resolve after discontinuation of MIRVASO topical gel.
6 ADVERSE REACTIONS
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
