Cutivate (Page 3 of 4)

ADVERSE REACTIONS

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%).

Table 2: Drug Related Adverse Events from Controlled Clinical Trials (n=438)
Adverse Events CUTIVATE® Lotion Vehicle
N=221 N=217
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%)
Table 3: Drug Related Adverse Events From Pediatric Open Label Trial (n=44)
Adverse Events CUTIVATE® Lotion Twice Daily
Dry skin at multiple sites 3 (7%)
Stinging at Application Sites 2 (5%)
Excoriation 1 (2%)

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.

Table 4: Adverse Events Occurring in ≥ 1% of Patients from Either Arm from Controlled Clinical Trials (n=438)
Body System CUTIVATE ® Lotion Vehicle Lotion
N = 221 N = 217
Any Adverse Event 77 (35%) 82 (38%)
Skin
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
Tract Infection
6 (3%) 7 (3%)
Gastrointestinal
Normal Tooth Eruption 2 (< 1%) 3 (1%)
Diarrhea 3 (1%) 0
Vomiting 3 (1%) 2 (<1%)
Lower Respiratory
Cough 7 (3%) 6 (3%)
Influenza 5 (2%) 0
Wheeze 0 3 (1%)
Neurology
Headache 4 (2%) 5 (2%)
Non-Site Specific
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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