Established safety profile across two phase 3 clinical trials, a long-term safety study, and an HPA axis suppression study2-4
DUOBRII Lotion is contraindicated in pregnancy.
DUOBRII Lotion contains tazarotene, which is a teratogenic substance. In females of reproductive potential, obtain a negative pregnancy test within 2 weeks prior to initiating treatment. Initiate DUOBRII Lotion therapy during a menstrual period. Advise female patients of reproductive potential to use an effective method of contraception during treatment.
- DUOBRII Lotion contains halobetasol propionate, a corticosteroid, and has been shown to suppress the HPA axis.
- DUOBRII Lotion was assessed in an 8-week HPA axis suppression study.
- Reversible HPA axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment.
- Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
- Systemic absorption may require evaluation for HPA axis suppression.
- Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
Some individuals may experience atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue until the integrity of the skin has been restored. Do not resume treatment if allergic contact dermatitis is identified. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.
Avoid exposure to sunlight, sunlamps, and weather extremes. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers. Patients must be instructed to use sunscreen and protective clothing when using DUOBRII Lotion. Patients with sunburn should be advised not to use DUOBRII Lotion until fully recovered. Patients who may have considerable sun exposure due to their occupation and those with inherent sensitivity to sunlight should exercise particular caution when using DUOBRII Lotion.
Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of DUOBRII Lotion until the infection has been adequately treated.
The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).
Adverse events seen in a long-term safety study through 8 weeks were consistent with those seen in the phase 3 studies.
Rate of epidermal atrophy during the long-term study was 0.7%.
The percentage of subjects with reported adverse events at 8 weeks did not increase throughout the rest of the study.