. 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.
Table 1 - Adverse Reactions Reported in Clinical Trials by At Least 1% of Subjects Treated for 29 Days
|
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 |
Open-label, Long-term Study
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 (> 4% of subjects) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).
Allergic contact dermatitis
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).
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 CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
