Clinical Trial Experience
In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE® (fluticasone propionate cream) Cream was approximately 4%. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.
Two clinical studies compared once- to twice-daily administration of CUTIVATE® (fluticasone propionate cream) Cream for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1. In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.
Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. CUTIVATE® (fluticasone propionate cream) Cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ± 6.92 mcg/dL, poststimulation mean value = 28.84 ± 7.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤ 18 μg/dL, indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 month after cessation of CUTIVATE® (fluticasone propionate cream) Cream; and telangiectasia, resolving within 3 months after stopping CUTIVATE® (fluticasone propionate cream) Cream.
Table 1: Drug-Related Adverse Events—Skin
(n = 210)
(n = 203)
(n = 78)
|Skin infection||1 (0.5%)||0||0|
|Infected eczema||1 (0.5%)||2 (1.0%)||0|
|Viral warts||0||1 (0.5%)||0|
|Herpes simplex||0||1 (0.5%)||0|
|Atopic dermatitis||1 (0.5%)||0||0|
|Exacerbation of||4 (1.9%)||1 (0.5%)||1 (1.3%)|
|Burning||2 (1.0%)||2 (1.0%)||2 (2.6%)|
|Stinging||0||2 (1.0%)||1 (1.3%)|
|Skin irritation||6 (2.9%)||2 (1.0%)||0|
|Pruritus||2 (1.0%)||4 (1.9%)||4 (5.1%)|
|pruritus||4 (1.9%)||1 (0.5%)||1 (1.3%)|
|Folliculitis||1 (0.5%)||1 (0.5%)||0|
|Dryness of skin||3 (1.4%)||1 (0.5%)||0|
Table 2: Adverse Events* From Pediatric Open-Label Trial (n = 51)
|Adverse Events||Fluticasone Twice Daily|
|Dusky erythema||1 (2.0%)|
|Erythematous rash||1 (2.0%)|
|Facial telangiectasia†||2 (4.9%)|
|Non-facial telangiectasia||1 (2.0%)|
|*See text for additional detail.
† n = 41.
Post Marketing Experience
Systemic adverse events with CUTIVATE® (fluticasone propionate cream) Cream and CUTIVATE® (fluticasone propionate cream) 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® (fluticasone propionate cream) Cream: skin discoloration, erythema, irritation, edema/swelling, atrophy, contusion, dermatitis, pain, sepsis, hemorrhage, acneiform eruptions.
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.