Clinical Trial Experience: In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. Events were local cutaneous events, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and inclusively were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection.
The incidence of drug-related events on drug compared to vehicle (4% and 5%, respectively) was similar. The incidence of drug-related events between study populations of 242 pediatric patients (age 3 months to < 17 years) and 196 adult patients (17 years or older) (4% and 5%, respectively) was also similar.
In an open-label study of 44 pediatric patients applying CUTIVATE® Lotion to at least 35% of body surface area twice daily for 3 or 4 weeks, the overall incidence of drug-related adverse events was 14%. Events were local, cutaneous, and inclusively were dry skin (7%), stinging at application site (5%), and excoriation (2%).
|Adverse Events||CUTIVATE® Lotion||Vehicle|
|Burning/Stinging skin||4 (2%)||3 (1%)|
|Contact Dermatitis||0||1 (<1%)|
|Exacerbation of Atopic dermatitis||0||1 (<1%)|
|Folliculitis of legs||2 (<1%)||0|
|Irritant Contact Dermatitis||0||1 (<1%)|
|Pruritus||1 (<1%)||1 (<1%)|
|Pustules on Arms||1 (<1%)||0|
|Rash||1 (<1%)||2 (<1%)|
|Skin Infection||0||3 (1%)|
|Adverse Events||CUTIVATE® Lotion Twice Daily|
|Dry skin at multiple sites||3 (7%)|
|Stinging at Application Sites||2 (5%)|
The table below summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in controlled clinical trials.
|Body System||CUTIVATE ® Lotion||Vehicle Lotion|
|N = 221||N = 217|
|Any Adverse Event||77 (35%)||82 (38%)|
|Burning and Stinging||4 (2%)||3 (1%)|
|Pruritus||3 (1%)||5 (2%)|
|Rash||2 (<1%)||3 (1%)|
|Skin Infection||0||3 (1%)|
|Ear, Nose, Throat|
|Common Cold||9 (4%)||5 (2%)|
|Ear Infection||3 (1%)||3 (1%)|
|Nasal Sinus Infection||2 (<1%)||4 (2%)|
|Rhinitis||1 (<1%)||3 (1%)|
| Upper Respiratory |
|6 (3%)||7 (3%)|
|Normal Tooth Eruption||2 (< 1%)||3 (1%)|
|Vomiting||3 (1%)||2 (<1%)|
|Cough||7 (3%)||6 (3%)|
|Headache||4 (2%)||5 (2%)|
|Fever||8 (4%)||8 (4%)|
|Seasonal Allergy||2 (<1%)||3 (1%)|
During the clinical trials, eczema herpeticum occurred in a 33-year-old male patient treated with CUTIVATE® Lotion. Additionally, a 4-month-old patient treated with CUTIVATE® Lotion in the open-label trial had marked elevations of the hepatic enzymes AST and ALT.
Post Marketing Experience: Systemic adverse events with CUTIVATE® Cream and CUTIVATE® Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).
The following localized adverse reactions have been reported during post approval use of CUTIVATE® Lotion: erythema, edema/swelling, bleeding, and a reported lack of efficacy.
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.
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