Bryhali Approval History
Reviewed by J.Stewart BPharm Last updated on Nov 13, 2018.
FDA Approved: Yes (First approved November 6, 2018)
Brand name: Bryhali
Generic name: halobetasol propionate
Dosage form: Lotion
Previous Name: Jemdel
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis
Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults.
DOSAGE AND ADMINISTRATION
- Apply a thin layer of Bryhali Lotion to the affected areas once daily.
- Discontinue treatment with Bryhali Lotion once the psoriasis is controlled. The treatment period should should not exceed 8 weeks.
- Avoid bandaging, wrapping or otherwise occluding the treatment area(s) unless directed by a physician.
- Avoid use on the face, groin, or axillae.
- Not for oral, ophthalmic, or intravaginal use.
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.
- Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria.
- Systemic absorption may require evaluation for HPA axis suppression.
- Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
- Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.
- Breastfeeding women should not apply Bryhali Lotion directly to the nipple and areola to avoid directly exposing the infant.
- Local adverse reactions may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible.
- 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.
- The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia.
Development History and FDA Approval Process for Bryhali
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