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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur with the potential for glucocorticosteroid insufficiency during or after treatment. ( 5.1 ) • Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. ( 5.1 ) • Systemic absorption may require evaluation for HPA axis suppression. ( 5.1 ) • Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. ( 5.1 ) • Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) • Local adverse reactions may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible. ( 5.2 ) • Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.3 ) 5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression BRYHALI Lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Systemic effects of topical corticosteroids may include reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment with the topical corticosteroid. The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression with BRYHALI Lotion was evaluated in a study of 19 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area (BSA). HPA axis suppression was reported for 1 (5.6%) subject at Week 4 and for 3 (15.8%) subjects at Week 8. All 3 subjects had normal HPA axis suppression test with discontinuation of treatment [see Clinical Pharmacology (12.2) ] . Because of the potential for systemic absorption, use of topical corticosteroids, including BRYHALI Lotion, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to corticosteroids. Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body-mass ratios [see Use in Specific Populations (8.4) ] . 5.2 Local Adverse Reactions Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely with occlusive use, prolonged use, or use of higher potency corticosteroids, including BRYHALI Lotion. Some local adverse reactions may be irreversible. 5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.4 Concomitant Skin Infections Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of BRYHALI Lotion until the infection has been adequately treated. 5.5 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue BRYHALI Lotion if allergic contact dermatitis occurs.
6 ADVERSE REACTIONS • The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia. ( 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, 426 adults with plaque psoriasis were treated with BRYHALI Lotion and had post-baseline safety data. Subjects applied BRYHALI Lotion once daily for up to 8 weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with BRYHALI Lotion and more frequently than in vehicle-treated subjects. Table 1: Adverse Reactions Occurring in ≥1% of the Subjects Treated with BRYHALI Lotion through Week 8 BRYHALI Lotion (N=284) Vehicle Lotion (N=142) Adverse Reaction % % Upper Respiratory Tract Infection 2% 1% Application Site Dermatitis 1% 0 Hyperglycemia 1% 0