BRYHALI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BRYHALI (BRYHALI).
BRYHALI (halobetasol propionate) is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects through the induction of phospholipase A2 inhibitory proteins (lipocortins), which inhibit the release of arachidonic acid and subsequent prostaglandin and leukotriene synthesis.
| Metabolism | Metabolized primarily in the liver via ester hydrolysis and subsequent glucuronidation. The exact enzymes involved are not fully characterized, but CYP450 enzymes are not significantly involved. |
| Excretion | Primarily hepatic metabolism followed by renal excretion of metabolites. Unchanged BRYHALI (isoniazid) is excreted renally: 50-70% as parent drug and metabolites (acetylisoniazid, isonicotinic acid) within 24 hours. Less than 5% excreted unchanged in feces. |
| Half-life | Terminal elimination half-life is 1-4 hours in fast acetylators and 2-5 hours in slow acetylators (AUC significantly higher in slow acetylators). This influences dosing frequency; slow acetylators may require lower doses to avoid accumulation and toxicity. |
| Protein binding | Approximately 10% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Volume of distribution is 0.61-0.74 L/kg (total body water). High distribution into all tissues and fluids, including cerebrospinal fluid (CSF) (concentrations ~50-100% of serum), reflecting excellent tissue penetration. |
| Bioavailability | Oral bioavailability is 100% (well absorbed from gastrointestinal tract). |
| Onset of Action | Oral: Antimycobacterial effect begins within 1-2 hours after administration (bactericidal against actively growing mycobacteria). Peak serum concentrations occur at 1-2 hours. |
| Duration of Action | Bactericidal activity persists for 12-24 hours, depending on acetylator phenotype and dose. In slow acetylators, therapeutic concentrations may last up to 24 hours, supporting once-daily dosing. |
Apply a thin layer to affected areas once daily. For psoriasis, maximum weekly dose of 60 g. Do not exceed 100 g per week. For atopic dermatitis, do not exceed 60 g per week.
| Dosage form | LOTION |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Approved for children ≥12 years. Apply a thin layer to affected areas once daily. Do not exceed 30 g per week for patients 12–17 years. |
| Geriatric use | No specific dose adjustment required. Use caution due to increased skin fragility and potential for systemic absorption. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BRYHALI (BRYHALI).
| Breastfeeding | It is not known whether halobetasol propionate is excreted in human milk after topical application. Systemic absorption is minimal, but when applied to large areas or for prolonged periods, excretion in milk is possible. Caution should be exercised. M/P ratio not available. Avoid application to breast area to prevent infant ingestion. Use lowest effective dose for shortest duration if required. |
| Teratogenic Risk | BRYHALI (halobetasol propionate) is a topical corticosteroid. Systemic absorption is minimal with topical use; however, when applied over large areas, under occlusion, or on damaged skin, sufficient absorption may occur to produce teratogenic effects. Corticosteroids are generally considered to have a low teratogenic risk in humans when used topically. Animal studies with halobetasol propionate have shown teratogenicity (cleft palate, skeletal abnormalities) at topical doses of 0.1 mg/kg/day in rats and rabbits. In pregnancy, avoid use on large areas, prolonged use, or occlusive dressings. First trimester: evidence of fetal harm in animals, but limited human data; avoid if possible. Second and third trimesters: use only if clearly needed and in smallest amount for shortest duration. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to halobetasol propionate or any component of the formulation"]
| Precautions | ["Systemic absorption may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with potential for glucocorticosteroid insufficiency after withdrawal.","Local adverse reactions including skin atrophy, striae, telangiectasias, and allergic contact dermatitis.","Use in pediatric patients may result in greater susceptibility to HPA axis suppression due to larger skin surface-to-body-mass ratio.","Avoid use on face, axillae, or groin due to increased risk of skin thinning.","Not recommended for use in patients with skin infections unless appropriate antimicrobial therapy is employed."] |
| Food/Dietary | No clinically relevant food interactions known. No dietary restrictions required. |
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| Fetal Monitoring | Monitor for signs of maternal hypothalamic-pituitary-adrenal (HPA) axis suppression if large areas are treated or occlusion is used. Monitor fetal growth if prolonged use on extensive body surface area. No specific fetal monitoring required for typical limited use. |
| Fertility Effects | No human studies on fertility effects. Animal studies with topical corticosteroids have shown no impairment of fertility at clinically relevant doses. Systemic corticosteroids can affect fertility; for topical halobetasol, effects are unlikely due to minimal absorption. |
| Clinical Pearls | BRYHALI (halobetasol propionate) is a super-high-potency topical corticosteroid indicated for plaque psoriasis in adults. Limit use to 2 consecutive weeks, apply no more than 50 g/week, and avoid use on face, groin, axillae, or intertriginous areas due to increased risk of systemic absorption and local adverse effects. Monitor for hypothalamic-pituitary-adrenal (HPA) axis suppression with prolonged use. Do not use with occlusive dressings unless directed. |
| Patient Advice | Apply a thin layer to affected areas only, once daily. Do not use on broken skin or areas with infection. · Do not use for longer than 2 weeks; do not use more than 50 grams total per week. · Avoid contact with eyes, mouth, and mucous membranes. Wash hands after application unless treating hands. · Do not cover treated area with bandages or other occlusive dressings unless specifically instructed by your doctor. · Inform your doctor if you develop signs of skin infection, worsening of psoriasis, or if no improvement is seen within 2 weeks. · Do not use other corticosteroid-containing products while using BRYHALI without consulting your doctor. |