Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS • 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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 410 adults with plaque psoriasis were treated with DUOBRII Lotion or vehicle lotion and had post-baseline safety data.
Subjects applied DUOBRII Lotion or vehicle lotion once daily for up to 8 weeks.
Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with DUOBRII Lotion and more frequently than in vehicle-treated subjects.
Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with DUOBRII Lotion through Week 8 Adverse Reaction DUOBRII Lotion (N=270) Vehicle Lotion (N=140) Contact Dermatitis 20 (7%) 0 Application Site Pain 7 (3%) 1 (1%) Folliculitis 5 (2%) 0 Skin Atrophy 5 (2%) 0 Excoriation 5 (2%) 0 Rash 4 (1%) 0 Skin Abrasion 3 (1%) 0 Skin Exfoliation 2 (1%) 0
5 WARNINGS AND PRECAUTIONS • 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 corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
(5.2) • Systemic absorption may require evaluation for HPA axis suppression.
Like all medications, Duobrii can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: