Bryhali lotion for topical treatment of plaque psoriasis in adults

Bryhali is a topical corticosteroid lotion containing halobetasol propionate 0.01%. It is approved for treating plaque psoriasis in adults by applying a thin layer to affected skin areas. The lotion belongs to the potent to superpotent class of corticosteroids and works by reducing inflammation and immune-related skin symptoms characteristic of psoriasis.

Bryhali lotion is indicated specifically for the topical treatment of plaque psoriasis in adults. It is intended for use on affected skin areas excluding the face, groin, and axillae.

Halobetasol propionate

Halobetasol propionate, the active ingredient in Bryhali lotion, is a synthetic corticosteroid that modulates cellular signaling, immune responses, and inflammation. While the exact mechanism in plaque psoriasis is not fully understood, it likely reduces skin inflammation and immune activation that contribute to psoriatic plaques.

Apply a thin layer of Bryhali lotion to affected areas once daily, rubbing in gently. Wash hands after application unless treating the hands. Do not use the lotion on the face, groin, or axillae. Treatment with Bryhali should not exceed 8 weeks, and total usage should not surpass approximately 50 grams per week. Discontinue treatment if psoriasis is controlled before 8 weeks. Do not use occlusive dressings unless advised by a physician. The lotion is for topical use only and must not be used orally, ophthalmically, or intravaginally.

None reported.

• Systemic effects: Bryhali lotion can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, which may result in glucocorticosteroid insufficiency during or after treatment.
• Risk factors for HPA axis suppression: Using potent corticosteroids on large skin areas, prolonged use, occlusive dressings, altered skin barrier, multiple corticosteroid products, liver failure, and young age increase systemic absorption risk.
• Local adverse reactions: May include skin atrophy, striae, telangiectasias, hypopigmentation, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria; some may be irreversible.
• Ophthalmic risks: Use may raise risk of posterior subcapsular cataracts and glaucoma. Patients should report visual symptoms and may require ophthalmologic evaluation.
• Infections: Existing or developing skin infections should be treated with appropriate antimicrobials. Discontinue Bryhali if infection does not improve.
• Allergic contact dermatitis: If suspected, discontinue Bryhali; diagnosis may be confirmed by patch testing.

In clinical trials, common adverse reactions (≥1%) included upper respiratory tract infections (2%), application site dermatitis (1%), and hyperglycemia (1%). Local skin reactions such as irritation or allergic dermatitis may also occur.

Concomitant use of more than one corticosteroid-containing product can increase systemic corticosteroid exposure and risk of adverse effects.

Pregnancy

No data are available on the use of Bryhali lotion in pregnant women. Animal studies demonstrated malformations such as cleft palate and omphalocele following systemic exposure to halobetasol propionate. The relevance of these findings to humans after topical use is unknown.

Lactation

It is unknown whether halobetasol propionate is present in human milk after topical use. Systemic corticosteroids appear in milk and may affect a breastfed infant. Breastfeeding women should avoid applying Bryhali lotion directly to the nipple and areola to limit infant exposure.