HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
DUOBRII safely and effectively. See full prescribing information for DUOBRII.
DUOBRII(halobetasol propionate and tazarotene)lotion, for topicaluse
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
DUOBRII Lotion is a combination of halobetasol propionate and tazaroteneindicated for the topical treatment of plaque psoriasis in adults. (1)
DOSAGE AND ADMINISTRATION
• Apply a thin layer of DUOBRII Lotion to the affected areas once daily.
• Not for oral, ophthalmic, or intravaginal use.
DOSAGE FORMS AND STRENGTHS
Lotion, 0.01%/0.045%
Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasolpropionate and 0.45 mg (0.045%) tazarotene. (3)
CONTRAINDICATIONS
DUOBRII Lotion is contraindicated in pregnancy (4.1, 8.1)
WARNINGS AND PRECAUTIONS
• Embryofetal risk: DUOBRII Lotion contains tazarotene, which is ateratogenic substance. In females of reproductive potential, obtain anegative pregnancy test within 2 weeks prior to initiating treatment andadvise patients to use an effective method of contraception duringtreatment. (5.1)
• Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression mayoccur, with the potential for glucocorticosteroid insufficiency during orafter treatment. (5.2)
• Systemic effects of topical corticosteroids may also include Cushing’ssyndrome, hyperglycemia, and glucosuria. (5.2)
• Systemic absorption may require eva luation for HPA axis suppression.
• Use of potent corticosteroids on large areas, for prolonged durations, underocclusive dressings, or on an altered skin barrier may increase systemicexposure. (5.2)
• Local Adverse Reactions: Local adverse reactions may include atrophy,striae, telangiectasias, and folliculitis. If these effects occur, discontinue at
least until the integrity of the skin has been restored. DUOBRII Lotionshould 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. DUOBRII Lotion should beadministered with caution if the patient is also taking drugs known to bephotosensitizers. (5.4)
• Ophthalmic Adverse Reactions: Use of topical corticosteroids mayincrease the risk of posterior subcapsular cataracts and glaucoma. If visualsymptoms occur, consider referral to an ophthalmologist (5.5).
ADVERSE REACTIONS
• The most common adverse reactions are contact dermatitis (7%),application site pain (3%), folliculitis (2%), skin atrophy (2%), andexcoriation (2%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact BauschHealth US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved
patient labeling.
Revised: 04/2019

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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Pregnancy
5 WARNINGS AND PRECAUTIONS
5.1 Embryofetal Risk
5.2 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and OtherUnwanted Systemic Glucocorticoid Effects
5.3 Local Adverse Reactions
5.4 Photosensitivity and Risk for Sunburn