Bryhali - Drug Monograph

Introduction

Bryhali (halobetasol propionate) lotion 0.01% is a high-potency topical corticosteroid approved by the FDA in 2018. It is specifically formulated for the treatment of plaque psoriasis in adults, offering a unique vehicle that provides enhanced delivery while maintaining favorable safety and efficacy profiles compared to other high-potency steroids.

Mechanism of Action

Halobetasol propionate, the active ingredient in Bryhali, is a synthetic corticosteroid that binds to intracellular glucocorticoid receptors. This complex modulates gene expression, resulting in:

• Inhibition of inflammatory cytokine production (IL-1, IL-2, TNF-α, IFN-γ)
• Suppression of phospholipase A2 activity, reducing prostaglandin and leukotriene synthesis
• Decreased vascular permeability and vasoconstriction
• Inhibition of lymphocyte and macrophage migration to inflamed tissues
• Reduction in epidermal hyperproliferation characteristic of psoriasis

The 0.01% concentration in a lotion formulation provides targeted delivery with reduced systemic absorption compared to higher concentration formulations.

Indications

• Treatment of plaque psoriasis in adults

• Lichen planus
• Discoid lupus erythematosus
• Other inflammatory dermatoses requiring high-potency topical steroids

Dosage and Administration

• Apply a thin layer to affected areas twice daily
• Maximum weekly dose: 50 g (or 50 mL)
• Treatment duration: Limited to 2 consecutive weeks
• Total treatment should not exceed 50 g per week

• Geriatric patients: Use with caution due to increased skin fragility
• Hepatic impairment: No specific dosage adjustment recommended
• Renal impairment: No specific dosage adjustment recommended
• Pediatric patients: Safety and effectiveness not established

• Apply to clean, dry skin
• Gently rub in completely
• Wash hands after application unless hands are being treated
• Avoid occlusive dressings unless directed by physician

Pharmacokinetics

• Systemic absorption depends on application site, skin integrity, and use of occlusive dressings
• Approximately 2.6% systemic absorption from psoriatic plaques
• Greater absorption occurs through broken skin or intertriginous areas

• Binds to plasma proteins (albumin and transcortin)
• Distributed throughout body tissues
• Crosses placenta and appears in breast milk

• Primarily hepatic via CYP3A4
• Metabolized to inactive compounds

• Renal excretion of metabolites (40-60%)
• Biliary excretion (remainder)
• Elimination half-life: Approximately 12-16 hours

Contraindications

• Hypersensitivity to halobetasol propionate or any component of the formulation
• Viral skin infections (herpes simplex, varicella, vaccinia)
• Fungal skin infections
• Bacterial skin infections without appropriate antimicrobial therapy
• Tuberculosis of the skin
• Perioral dermatitis
• Rosacea
• Acne vulgaris

Warnings and Precautions

• May cause reversible HPA axis suppression with potential for glucocorticoid insufficiency
• Cushing's syndrome and hyperglycemia may occur with prolonged use
• Greater risk in patients with large treatment areas, prolonged use, or use of occlusive dressings

• Skin atrophy, striae, telangiectasia may occur
• May mask symptoms of underlying skin infections
• Contact dermatitis possible

• Pregnancy: Category C - Use only if potential benefit justifies potential risk
• Lactation: Systemically absorbed corticosteroids may appear in breast milk
• Pediatrics: Higher risk of systemic toxicity due to larger surface area to body weight ratio

Drug Interactions

• Other topical products: May enhance absorption of other topically applied medications
• Strong CYP3A4 inhibitors: May increase systemic exposure to halobetasol
• Live vaccines: Avoid administration during treatment due to immunosuppressive effects

• Additive effects with other systemic corticosteroids
• Potential interaction with other immunosuppressive agents

Adverse Effects

• Application site reactions (burning, stinging, itching)
• Folliculitis
• Dry skin
• Skin atrophy
• Striae

• HPA axis suppression
• Glaucoma (with periocular use)
• Secondary infections
• Allergic contact dermatitis
• Vision changes (with periocular use)

Monitoring Parameters

• Baseline assessment of skin condition
• Documentation of treatment area size

• Clinical response assessment at 2-week intervals
• Signs of HPA axis suppression (if risk factors present)
• Local skin reactions (atrophy, telangiectasia)
• Development of secondary infections
• Intraocular pressure if applied near eyes

• Assessment for rebound flare
• Monitoring for steroid withdrawal symptoms if used long-term

Patient Education

• Use only as directed by healthcare provider
• Apply thin layer only to affected areas
• Wash hands after application unless hands are being treated
• Avoid contact with eyes, mouth, and mucous membranes

• Do not use longer than prescribed (maximum 2 weeks)
• Report any signs of skin infection or worsening condition
• Avoid occlusive dressings unless specifically instructed
• Inform all healthcare providers about Bryhali use

• Store at room temperature (20-25°C)
• Keep away from heat and open flame
• Discard unused medication after treatment course
• Do not use on broken or infected skin unless directed

• Severe skin irritation or burning
• Signs of infection (redness, swelling, pus)
• No improvement after 2 weeks of treatment
• Symptoms of systemic absorption (weight gain, fatigue, dizziness)

References

1. FDA prescribing information: Bryhali (halobetasol propionate) lotion, 0.01%. 2018. 2. Jarratt M, et al. Halobetasol propionate lotion 0.01% for the treatment of plaque psoriasis. J Drugs Dermatol. 2019;18(10):990-995. 3. Kircik L, et al. Safety and efficacy of halobetasol propionate 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis. J Clin Aesthet Dermatol. 2019;12(5):12-18. 4. Data on file. Ortho Dermatologics. 5. Wolverton SE. Comprehensive Dermatologic Drug Therapy. 4th ed. Elsevier; 2020. 6. Zito PM, Scharf R. Halobetasol. [Updated 2023 May 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan.