In the 12-month, open-label, active-controlled, long-term safety trial in adults and adolescents 12 years of age and older, 404 patients with perennial allergic rhinitis or vasomotor rhinitis were treated with DYMISTA 1 spray per nostril twice daily and 207 patients were treated with fluticasone propionate nasal spray, 2 sprays per nostril once daily. Overall, adverse reactions were 47% in the DYMISTA treatment group and 44% in the fluticasone propionate nasal spray group. The most frequently reported adverse reactions ( ≥ 2%) with DYMISTA were headache, pyrexia, cough, nasal congestion, rhinitis, dysgeusia, viral infection, upper respiratory tract infection, pharyngitis, pain, diarrhea, and epistaxis. In the DYMISTA treatment group, 7 patients (2%) had mild epistaxis and 1 patient ( < 1%) had moderate epistaxis. In the fluticasone propionate nasal spray treatment group 1 patient ( < 1%) had mild epistaxis. No patients had reports of severe epistaxis. Focused nasal examinations were performed and no nasal ulcerations or septal perforations were observed. Eleven of 404 patients (3%) treated with DYMISTA and 6 of 207 patients (3%) treated with fluticasone propionate nasal spray discontinued from the trial due to adverse events.
In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from % to % or from to mg/kg/day of clobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organs systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.
Initial dose based on previous asthma drug therapy and disease severity; 100 mcg via oral inhalation once daily is the usual recommended starting dose for patients not on an inhaled corticosteroid. After 2 weeks of therapy, if asthma symptoms are uncontrolled, increase dose to 200 mcg via oral inhalation once daily. Max: 200 mcg once daily. Administer at the same time each day. The maximum beneficial effect may not be achieved for up to 2 weeks or longer after starting treatment. Titrate to the lowest effective dose once asthma stability is achieved.