Bryhali
Generic: HALOBETASOL PROPIONATE
Basic Information
Manufacturer
Bausch Health US, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
d4bbb66a-3f9d-4091-b1b0-1cbc908432d3
Indications & Usage
1 INDICATIONS AND USAGE BRYHALI ® (halobetasol propionate) lotion, 0.01% is indicated for the topical treatment of plaque psoriasis in adults.
BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults.
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BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults.
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Adverse Reactions
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
( 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