MIRVASO

AbsorptionThe absorption of brimonidine from MIRVASO topical gel was evaluated in a clinical trial in 24 adult subjects with facial erythema associated with rosacea. All enrolled subjects received once daily topical application of MIRVASO topical gel 1 gram to the entire face for 29 days. Pharmacokinetic assessments were performed on Day 1, Day 15, and Day 29. The mean plasma maximum concentration (C max ) and area under the concentration-time curve (AUC) were highest on Day 15, with C max and ...

MIRVASO topical gel was evaluated for the treatment of moderate to severe, persistent (nontransient) facial erythema of rosacea in two randomized, double-blind, vehicle-controlled clinical trials, which were identical in design. The trials were conducted in 553 subjects aged 18 years and older who were treated once daily for 4 weeks with either MIRVASO topical gel or vehicle. Overall, 99% of subjects were Caucasian and 76% were female. Baseline disease severity was graded using a 5-point Clinical Erythema Assessment (CEA) scale and a 5-point Patient Self Assessment (PSA) scale, on which subjec...

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 ) ] Local Vasomotor Adverse Reactions [see Warnings and Precautions ( 5.5 ) ] Hypersensitivity [see Warnings and Precautions ( 5.6 ) ] In controlled clinical trials with MIRVASO topical gel the most common adverse reactions (incidence > 1%) included erythema, flushing, skin burning sensation, and cont...

MIRVASO topical gel is contratindicated in patients who have experienced a hypersensitivity reaction to any component. Reactions have included angioedema, urticaria, and contact dermatitis [see Warnings and Precautions (5.6) and Adverse Reactions (6.1 , 6.2 ) ]. Known hypersensitivity to any component of MIRVASO topical gel ( 4 )

Potentiation of Vascular Insufficiency ( 5.1 ) Severe Cardiovascular Disease ( 5.2 ) Serious Adverse Reactions Following Ingestion of MIRVASO topical gel ( 5.3 ) Systemic Adverse Reactions of Alpha-2 Adrenergic Agonists ( 5.4 ) Local Vasomotor Adverse Reactions ( 5.5 ) Hypersensitivity ( 5.6 ) 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, th...

7 DRUG INTERACTIONS 7.1 Anti-hypertensives/Cardiac Glycosides Alpha-2 agonists, as a class, may reduce blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised. 7.2 CNS Depressants Although specific drug-drug interactions studies have not been conducted with MIRVASO topical gel, the possibility of an additive or potentiating effect with ...