Clinical Safety Data. DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%

Favorable safety profile across two phase 3 clinical trials, a long-term safety study, and an HPA axis suppression study^1-3

Pregnancy and embryofetal toxicity¹

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 and advise patients to use an effective method of contraception during treatment.

Hypothalamic-pituitary-adrenal (HPA) axis suppression and other unwanted systemic glucocorticoid effects¹

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.

Local adverse reactions¹

Some individuals may experience atrophy, striae, telangiectasias, and folliculitis. If these effects occur, discontinue until the integrity of the skin has been restored. DUOBRII Lotion should not be used on eczematous skin, as it may cause severe irritation.

Photosensitivity and risk for sunburn¹

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.

Ophthalmic adverse reactions¹

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.

Concomitant skin infections¹

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.

Most common AEs

The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).¹

No serious treatment-related AEs were reported.²

Safety data available through 1 year when used as needed³

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.

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Indication

DUOBRII^® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is indicated for the topical treatment of plaque psoriasis in adults.

Important Safety Information

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions

Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control. A negative result for pregnancy should be obtained within 2 weeks prior to treatment. If the patient becomes pregnant during treatment, discontinue DUOBRII Lotion and advise patient of the potential hazard to the fetus.
DUOBRII Lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis during or after treatment and may require that patients be evaluated periodically during treatment.
Predisposing factors for HPA axis suppression include: use of more potent corticosteroids, use on large areas, use under occlusive dressings, use on altered skin barrier, concomitant use of other steroids, liver failure and young age.
Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
Local adverse reactions may include atrophy, striae, telangiectasias, folliculitis and contact dermatitis. If these effects occur, discontinue until the integrity of the skin has been restored. Do not resume treatment if 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. Patients with sunburn should be advised not to use DUOBRII Lotion until fully recovered. DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers because of the increased potential for photosensitivity.
Topical corticosteroids may increase the risk of cataracts and glaucoma; advise patients to report any visual symptoms and refer to an ophthalmologist if needed.

Adverse Events

The most common adverse events in clinical trials were contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please click here for full Prescribing Information.

References: 1. DUOBRII Lotion [prescribing information]. Bridgewater, Bausch Health US, LLC. 2. Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: results of 2 phase 3 randomized controlled trials. J Am Acad Dermatol. 2018;79(2):287-293. 3. Data on file.