†Treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' at week 8 primary endpoint.2
‡The treatment difference at week 2 in trial 2 was not statistically significant.
¶Reported as 'erythema' in both phase 3 clinical trials. **Statistical significance was seen for plaque elevation at week 4 (43.0% vs 18.5%). P<0.001 from trials 1 and 2.
††Treatment success defined as at least a 2-grade improvement from baseline in Investigator's Global Assessment (IGA) score as well as a score of 'clear' or 'almost clear' at week 2 primary endpoint.2QD = once daily
BRYHALI Lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis during or upon withdrawal from treatment with a topical corticosteroid; therefore, patients may require periodic evaluation for evidence of HPA axis suppression. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid.1
The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression with BRYHALI Lotion was evaluated in a study of 19 adult subjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area (BSA). HPA axis suppression was reported for 1 (5.6%) subject at Week 4 and for 3 (15.8%) subjects at Week 8. All 3 subjects had a normal HPA axis suppression test with discontinuation of treatment.1
Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, hypopigmentation and allergic contact dermatitis. Some local adverse reactions may be irreversible1
Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.1
Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of BRYHALI Lotion until the infection has been adequately treated.1
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue BRYHALI Lotion if allergic contact dermatitis occurs.1
In two 8-week phase 3 trials, 0.0% of BRYHALI Lotion patients in trial 1 and 1.5% in trial 2 experienced epidermal atrophy vs 0.0% and 1.5% for those using vehicle (respectively). In both groups, all cases of epidermal atrophy were already present at baseline.2
‡‡Reported as burning/stinging in both phase 3 clinical trials.
§§In a phase 2 trial, there was 1 case of epidermal atrophy reported at week 6, which was not reported at weeks 8 and 12.3
Transmission electron micrograph of BRYHALI Lotion. Magnified 1,000 times.
¶¶The clinical significance of these ex vivo data has not been established.
As little as a $65 co-pay for eligible patients whose commercial insurance does not cover BRYHALI Lotion†
*This offer is only valid for patients with commercial insurance. Uninsured patients are not eligible for this savings offer. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including but not limited to Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration, or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid where otherwise prohibited, taxed, or otherwise restricted. Click here for full eligibility terms and conditions.
†Insured not covered is defined as a patient who has commercial insurance but the drug is not covered on the plan’s formulary or has an NDC block, prior authorization, step edit or other restriction that has not been met.