A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cutivate Side Effects, and Drug Interactions - Fluticasone
Cutivate Side Effects, and Drug Interactions - Fluticasone
SIDE EFFECTS
In controlled clinical trials of twice-daily administration, the total incidence
of adverse reactions associated with the use of CUTIVATE 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
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 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 Cream; and telangiectasia, resolving within 3 months
after stopping CUTIVATE Cream.
Table 1: Drug-Related Adverse Events Skin
|
Adverse Events
|
Fluticasone Once Daily
(n = 210) |
Fluticasone Twice Daily
(n = 203) |
Vehicle Twice Daily
(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 |
|
Impetigo
|
1 (0.5%) |
0 |
0 |
|
Atopic dermatitis
|
1 (0.5%) |
0 |
0 |
|
Eczema
|
1 (0.5%) |
0 |
0 |
|
Exacerbation of eczema
|
4 (1.9%) |
1 (0.5%) |
1 (1.3%) |
|
Erythema
|
0 |
2 (1.0%) |
0 |
|
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%) |
|
Exacerbation of pruritus
|
4 (1.9%) |
1 (0.5%) |
1 (1.3%) |
|
Folliculitis
|
1 (0.5%) |
1 (0.5%) |
0 |
|
Blisters
|
0 |
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 |
|
Burning
|
1 (2.0%) |
|
Dusky erythema
|
1 (2.0%) |
|
Erythematous rash
|
1 (2.0%) |
|
Facial telangiectasia **
|
2 (4.9%) |
|
Non-facial telangiectasia
|
1 (2.0%) |
|
Urticaria
|
1 (2.0%) |
* See text for additional detail. ** n = 41.
The following local adverse reactions have been reported infrequently with
topical corticosteroids, and they may occur more frequently with the use of
occlusive dressings and higher potency corticosteroids. These reactions are
listed in an approximately decreasing order of occurrence: irritation, folliculitis,
acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact
dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there
are reports of the development of pustular psoriasis from chronic plaque psoriasis
following reduction or discontinuation of potent topical corticosteroid products.
DRUG INTERACTIONS
No Information Provided.
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