IMPOYZ™ (clobetasol propionate) Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Topical corticosteroids, including IMPOYZ Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment.
- This may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose to HPA axis suppression include, use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
- If HPA axis suppression occurs, gradually withdraw the drug, reduce frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of withdrawal occur, systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
- Although rare, systemic effects of topical corticosteroids may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria.
Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios
Local Adverse Reactions with Topical Corticosteroids
- Local adverse reactions from topical corticosteroids may be more likely to occur with occlusion, prolonged use, or use of higher potency corticosteroids. Some local adverse reactions may be irreversible.
Concomitant Skin Infections
- Use an appropriate antimicrobial agent if a skin infection is present or develops. If appropriate, discontinue use of IMPOYZ Cream.
Allergic Contact Dermatitis
- Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation.
- The adverse reaction that occurred in at least 1% of subjects treated with IMPOYZ Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with IMPOYZ Cream were application site atrophy, telangiectasia and rash.
Please see Full Prescribing Information including Patient Information for additional information.
Reference: 1. Prescribing Information for Impoyz. Encore Dermatology, Inc., Malvern, PA.