Established safety profile across two phase 3 clinical trials, a long-term safety study, and an HPA axis suppression study2-4

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. Initiate DUOBRII Lotion therapy during a menstrual period. Advise female patients of reproductive potential to use an effective method of contraception during treatment.

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

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. 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.

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 AEs1

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

Safety data available through 1 year when used as needed3,4

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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Important Safety Information and Indication

Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions
  • Embryofetal risks. Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control during treatment with DUOBRII. 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.
  • Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Unwanted Systemic Glucocorticoid Effects. 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. 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. Photosensitivity and Risk for Sunburn. 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 of augmented photosensitivity.
  • Ophthalmic Adverse Reactions. Topical corticosteroids may increase the risk of cataracts and glaucoma; advise patients to report any visual symptoms and refer to an ophthalmologist if needed.
  • Concomitant Skin Infections: An appropriate antimicrobial agent should be used if skin infection is present or develops. If favorable response does not promptly occur, discontinue use of DUOBRII until infection has been adequately treated.
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.

Indication

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

Please click here for full Prescribing Information.

References: 1. Ozyurekoglu E, Kircik LH. An open-label pilot study to investigate safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of scalp psoriasis. J Drugs Dermatol. 2021;20(11):1191-1194. 2. DUOBRII Lotion [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. 3. Lebwohl MG, Stein Gold L, Papp K, et al. Long-term safety and efficacy of a fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis: phase 3 open-label study. J Eur Acad Dermatol Venereol. 2021;35(5):1152-1160. 4. Data on file.

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Important Safety Information and Indication

Important Safety Information and Indication

See More
Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions
  • Embryofetal risks. Women of child-bearing potential should be warned of the potential risk of fetal harm from DUOBRII and use adequate birth-control during treatment with DUOBRII. 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.
Contraindication

DUOBRII Lotion is contraindicated in pregnancy.

Warnings and Precautions