"The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.
Siliq is intended for patients who are candidates for systemic therapy "...
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In controlled, clinical trials with CLOBEX® Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.
Table 1 : Commonly Occurring Adverse Reactions ( ≥ 1%
|Adverse Reaction||Clobetasol Propionate 0.05% Spray
|System Organ Class|
|General disorders and administration site conditions||50 (42%)||56 (47%)|
|Application site burning||48 (40%)||56 (47%)|
|Application site dryness||2 (2%)||0 (0%)|
|Application site irritation||1 (1%)||0 (0%)|
|Application site pain||1 (1%)||2 (2%)|
|Application site pigmentation changes||1 (1%)||0 (0%)|
|Application site pruritus||4 (3%)||3 (3%)|
|Infections and infestations||17 (14%)||12 (10%)|
|Nasopharyngitis||6 (5%)||3 (3%)|
|Pharyngitis streptococcal||1 (1%)||0 (0%)|
|Upper respiratory tract infection||10 (8%)||2 (2%)|
|Skin and subcutaneous tissue disorders||4 (3%)||2 (2%)|
|Eczema asteatotic||2 (2%)||0 (0%)|
Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.
Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post-approval use of CLOBEX® Spray, 0.05%.
Read the Clobex Spray (clobetasol propionate spray) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/14/2012
Additional Clobex Spray Information
Clobex Spray - User Reviews
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