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.

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