DUOBRII

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Systemic exposure following topical application of DUOBRII Lotion was evaluated in the same study that evaluated the HPA axis suppression. It was an open-label, randomized, pharmacokinetics (PK) study conducted in subjects aged 18 years and older with moderate to severe plaque psoriasis affecting at least 20% body surface area. The PK of halobetasol propionate, tazarotene, and...

The safety and efficacy of once daily use of DUOBRII Lotion for the treatment of moderate to severe plaque psoriasis were assessed in two prospective, multicenter, randomized, double-blind clinical trials (Trial 1 [NCT02462070] and Trial 2 [NCT02462122]). These trials were conducted in 418 subjects 18 years of age and older with moderate to severe plaque psoriasis that covered a body surface area (BSA) between 3% and 12% excluding the face, scalp, palms, soles, axillae, and intertriginous areas. Disease severity was determined by a 5-grade Investigator’s Global Assessment (IGA). Subjects appli...

• The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rate...

DUOBRII Lotion is contraindicated in pregnancy ( 4.1 , 8.1 ) 4.1 Pregnancy DUOBRII Lotion is contraindicated in pregnancy [see Warnings and Precautions (5.1) , Use in Specific Populations ( 8.1 , 8.3) ].

• Embryofetal risk : 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. (5.1)
• Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. (5.2)
• Systemic effects of topical cortico...