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
Elidel Side Effects, and Drug Interactions - Pimecrolimus
Elidel Side Effects, and Drug Interactions - Pimecrolimus
SIDE EFFECTS
In human dermal safety studies, Elidel® (pimecrolimus)
Cream 1% did not induce contact sensitization, phototoxicity, or photoallergy,
nor did it show any cumulative irritation.
In a one-year safety study in pediatric patients age 2-17 years
old involving sequential use of Elidel Cream and a topical corticosteroid, 43%
of Elidel patients and 68% of vehicle patients used corticosteroids during the
study. Corticosteroids were used for more than 7 days by 34% of Elidel patients
and 54% of vehicle patients. An increased incidence of impetigo, skin infection,
superinfection (infected atopic dermatitis), rhinitis, and urticaria were found
in the patients that had used Elidel Cream and topical corticosteroid sequentially
as compared to Elidel Cream alone.
In 3 randomized, double-blind vehicle-controlled pediatric
studies and one active-controlled adult study, 843 and 328 patients respectively,
were treated with Elidel Cream. In these clinical trials, 48 (4%) of the 1171
Elidel patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy
due to adverse events. Discontinuations for AEs were primarily due to application
site reactions, and cutaneous infections. The most common application site reaction
was application site burning, which occurred in 8%-26% of patients treated with
Elidel Cream. The following table depicts the incidence of adverse events
pooled across the 2 identically designed 6-week studies with their open label
extensions and the 1-year safety study for pediatric patients ages 2-17. Data
from the adult active-controlled study is also included in this table. Adverse
events are listed regardless of relationship to study drug.
|
Treatment Emergent Adverse Events ( = 1%) in Elidel®
Treatment Groups
|
|
Elidel® Cream
|
Pediatric Patients* Vehicle-Controlled (6 weeks)
|
Pediatric Patients* Open-Label (20 weeks)
|
Pediatric Patients* Vehicle-Controlled (1 year)
|
Adult Active Comparator (1 year)
|
|
Elidel® Cream
|
Vehicle
|
Elidel® Cream
|
Elidel® Cream
|
Vehicle
|
| |
(N=267)
|
(N=136)
|
(N=335)
|
(N=272)
|
(N=75)
|
(N=328)
|
| |
N (%)
|
N (%)
|
N (%)
|
N (%)
|
N (%)
|
N (%)
|
|
At least 1 AE
|
182(68.2%)
|
97 (71.3%)
|
240(72.0%)
|
230(84.6%)
|
56(74.7%)
|
256 (78.0%)
|
|
Infections and Infestations
|
|
Upper Respiratory
|
|
Tract Infection NOS
|
38 (14.2%)
|
18 (13.2%)
|
65 (19.4%)
|
13 (4.8%)
|
6 (8.0%)
|
14 (4.3%)
|
| Nasopharyngitis |
27 (10.1%) |
10 (7.4%) |
32 (19.6%) |
72 (26.5%) |
16 (21.3%) |
25 (7.6%) |
|
Skin Infection NOS
|
8 (3.0%)
|
9 (5.1%)
|
18 (5.4%)
|
6 (2.2%)
|
3 (4.0%)
|
21 (6.4%)
|
|
Influenza
|
8 (3.0%)
|
1 (0.7%)
|
22 (6.6%)
|
36 (13.2%)
|
3 (4.0%)
|
32 (9.8%)
|
|
Ear Infection NOS
|
6 (2.2%)
|
2 (1.5%)
|
19 (5.7%)
|
9 (3.3%)
|
1 (1.3%)
|
2 (0.6%)
|
|
Otitis Media
|
6 (2.2%)
|
1 (0.7%)
|
10 (3.0%)
|
8 (2.9%)
|
4 (5.3%)
|
2 (0.6%)
|
|
Impetigo
|
5 (1.9%)
|
3 (2.2%)
|
12 (3.6%)
|
11 (4.0%)
|
4 (5.3%)
|
8 (2.4%)
|
|
Bacterial Infection
|
4 (1.5%)
|
3 (2.2%)
|
4 (1.2%)
|
3 (1.1%)
|
0
|
6 (1.8%)
|
|
Folliculitis
|
3 (1.1%)
|
1 (0.7%)
|
3 (0.9%)
|
6 (2.2%)
|
3 (4.0%)
|
20 (6.1%)
|
|
Sinusitis
|
3 (1.1%)
|
1 (0.7%)
|
11 (3.3%)
|
6 (2.2%)
|
1 (1.3%)
|
2 (0.6%)
|
|
Pneumonia NOS
|
3 (1.1%)
|
1 (0.7%)
|
5 (1.5%)
|
0
|
1 (1.3%)
|
1 (0.3%)
|
|
Pharyngitis NOS
|
2 (0.7%)
|
2 (1.5%)
|
3 (0.9%)
|
22 (8.1%)
|
2 (2.7%)
|
3 (0.9%)
|
|
Pharyngitis Streptococcal
|
2 (0.7%)
|
2 (1.5%)
|
10 (3.0%)
|
0
|
<1%
|
0
|
|
Molluscum Contagiosum
|
2 (0.7%)
|
0
|
4 (1.2%)
|
5 (1.8%)
|
0
|
0
|
|
Staphylococcal Infection
|
1 (0.4%)
|
5 (3.7%)
|
7 (2.1%)
|
0
|
<1%
|
3 (0.9%)
|
|
Bronchitis NOS
|
1 (0.4%)
|
3 (2.2%)
|
4 (1.2%)
|
29 (10.7%)
|
6 (8.0%)
|
8 (2.4%)
|
|
Herpes Simplex
|
1 (0.4%)
|
0
|
4 (1.2%)
|
9 (3.3%)
|
2 (2.7%)
|
13 (4.0%)
|
|
Tonsillitis NOS
|
1 (0.4%)
|
0
|
3 (0.9%)
|
17 (6.3%)
|
0
|
2 (0.6%)
|
|
Viral Infection NOS
|
2 (0.7%)
|
1 (0.7%)
|
1 (0.3%)
|
18 (6.6%)
|
1 (1.3%)
|
0
|
|
Gastroenteritis NOS
|
0
|
3 (2.2%)
|
2 (0.6%)
|
20 (7.4%)
|
2 (2.7%)
|
6 (1.8%)
|
|
Chickenpox
|
2 (0.7%)
|
0
|
3 (0.9%)
|
8 (2.9%)
|
3 (4.0%)
|
1 (0.3%)
|
|
Skin Papilloma
|
1 (0.4%)
|
0
|
2 (0.6%)
|
9 (3.3%)
|
<1%
|
0
|
|
Tonsillitis Acute NOS
|
0
|
0
|
0
|
7 (2.6%)
|
0
|
0
|
|
Upper Respiratory
|
|
Tract Infection Viral NOS
|
1 (0.4%)
|
0
|
3 (0.9%)
|
4 (1.5%)
|
0
|
1 (0.3%)
|
|
Herpes Simplex Dermatitis
|
0
|
0
|
1 (0.3%)
|
4 (1.5%)
|
0
|
2 (0.6%)
|
|
Bronchitis Acute NOS
|
0
|
0
|
0
|
4 (1.5%)
|
0
|
0
|
|
Eye Infection NOS
|
0
|
0
|
0
|
3 (1.1%)
|
<1%
|
1 (0.3%)
|
|
General Disorders and Administration Site Conditions
|
|
Application Site Burning
|
28(10.4%)
|
17(12.5%)
|
5 (1.5%)
|
23 (8.5%)
|
5 (6.7%)
|
85 (25.9%)
|
|
Pyrexia
|
20 (7.5%)
|
12 (8.8%)
|
41(12.2%)
|
34(12.5%)
|
4 (5.3%)
|
4 (1.2%)
|
|
Application Site Reaction NOS
|
8 (3.0%)
|
7 (5.1%)
|
7 (2.1%)
|
9 (3.3%)
|
2 (2.7%)
|
48 (14.6%)
|
|
Application Site Irritation
|
8 (3.0%)
|
8 (5.9%)
|
3 (0.9%)
|
1 (0.4%)
|
3 (4.0%)
|
21 (6.4%)
|
|
Influenza Like Illness
|
1 (0.4%)
|
0
|
2 (0.6%)
|
5 (1.8%)
|
2 (2.7%)
|
6 (1.8%)
|
|
Application Site Erythema
|
1 (0.4%)
|
0
|
0
|
6 (2.2%)
|
0
|
7 (2.1%)
|
|
Application Site Pruritus
|
3 (1.1%)
|
2 (1.5%)
|
2 (0.6%)
|
5 (1.8%)
|
0
|
18 (5.5%)
|
|
Respiratory, Thoracic and Mediastinal Disorders
|
|
Cough
|
31 (11.6%)
|
11 (8.1%)
|
31 (9.3%)
|
43 (15.8%)
|
8 (10.7%)
|
8 (2.4%)
|
|
Nasal Congestion
|
7 (2.6%)
|
2 (1.5%)
|
6 (1.8%)
|
4 (1.5%)
|
1 (1.3%)
|
2 (0.6%)
|
|
Rhinorrhea
|
5 (1.9%)
|
1 (0.7%)
|
3 (0.9%)
|
1 (0.4%)
|
1 (1.3%)
|
0
|
|
Asthma Aggravated
|
4 (1.5%)
|
3 (2.2%)
|
13 (3.9%)
|
3 (1.1%)
|
1 (1.3%)
|
0
|
|
Sinus Congestion
|
3 (1.1%)
|
1 (0.7%)
|
2 (0.6%)
|
<1%
|
<1%
|
3 (0.9%)
|
|
Rhinitis
|
1 (0.4%)
|
0
|
5 (1.5%)
|
12(4.4%)
|
5 (6.7%)
|
7 (2.1%)
|
|
Wheezing
|
1 (0.4%)
|
1 (0.7%)
|
4 (1.2%)
|
2 (0.7%)
|
<1%
|
0
|
|
Asthma NOS
|
2 (0.7%)
|
1 (0.7%)
|
11 (3.3%)
|
10(3.7%)
|
2 (2.7%)
|
8 (2.4%)
|
|
Epistaxis
|
0
|
1 (0.7%)
|
0
|
9 (3.3%)
|
1 (1.3%)
|
1 (0.3%)
|
|
Dyspnea NOS
|
0
|
0
|
0
|
5 (1.8%)
|
1 (1.3%)
|
2 (0.6%)
|
|
Gastrointestinal Disorders
|
|
Abdominal Pain Upper
|
11 (4.1%)
|
6 (4.4%)
|
10 (3.0%)
|
15(5.5%)
|
5 (6.7%)
|
1 (0.3%)
|
|
Sore Throat
|
9 (3.4%)
|
5 (3.7%)
|
15 (5.4%)
|
22(8.1%)
|
4 (5.3%)
|
12 (3.7%)
|
|
Vomiting NOS
|
8 (3.0%)
|
6 (4.4%)
|
14 (4.2%)
|
18(6.6%)
|
6 (8.0%)
|
2 (0.6%)
|
|
Diarrhea NOS
|
3 (1.1%)
|
1 (0.7%)
|
2 (0.6%)
|
21(7.7%)
|
4 (5.3%)
|
7 (2.1%)
|
|
Nausea
|
1 (0.4%)
|
3 (2.2%)
|
4 (1.2%)
|
11(4.0%)
|
5 (6.7%)
|
6 (1.8%)
|
|
Abdominal Pain NOS
|
1 (0.4%)
|
1 (0.7%)
|
5 (1.5%)
|
12 (4.4%)
|
3 (4.0%)
|
1 (0.3%)
|
|
Toothache
|
1 (0.4%)
|
1 (0.7%)
|
2 (0.6%)
|
7 (2.6%)
|
1 (1.3%)
|
2 (0.6%)
|
|
Constipation
|
1 (0.4%)
|
0
|
2 (0.6%)
|
10 (3.7%)
|
<1%
|
0
|
|
Loose Stools
|
0
|
1 (0.7%)
|
4 (1.2%)
|
<1%
|
<1%
|
0
|
|
Reproductive System and Breast Disorders
|
|
Dysmenorrhea
|
3 (1.1%)
|
0
|
5 (1.5%)
|
3 (1.1%)
|
1 (1.3%)
|
4 (1.2%)
|
|
Eye Disorders
|
|
Conjunctivitis NEC
|
2 (0.7%)
|
1 (0.7%)
|
7 (2.1%)
|
6 (2.2%)
|
3 (4.0%)
|
10 (3.0%)
|
|
Skin & Subcutaneous Tissue Disorders
|
|
Urticaria
|
3 (1.1%)
|
0
|
1 (0.3%)
|
1 (0.4%)
|
<1%
|
3 (0.9%)
|
|
Acne NOS
|
0
|
1 (0.7%)
|
1 (0.3%)
|
4 (1.5%)
|
<1%
|
6 (1.8%)
|
|
Immune System Disorders
|
|
Hypersensitivity NOS
|
11 (4.1%)
|
6 (4.4%)
|
16 (4.8%)
|
14 (5.1%)
|
1 (1.3%)
|
11 (3.4%)
|
|
Injury and Poisoning
|
|
Accident NOS
|
3 (1.1%)
|
1 (0.7%)
|
1 (0.3%)
|
<1%
|
1 (1.3%)
|
0
|
|
Laceration
|
2 (0.7%)
|
1 (0.7%)
|
5 (1.5%)
|
<1%
|
<1%
|
0
|
|
Musculoskeletal, Connective Tissue and Bone Disorders
|
|
Back Pain
|
1 (0.4%)
|
2 (1.5%)
|
1 (0.3%)
|
<1%
|
0
|
6 (1.8%)
|
|
Arthralgias
|
0
|
0
|
1 (0.3%)
|
3 (1.1%)
|
1 (1.3%)
|
5 (1.5%)
|
|
Ear and Labyrinth Disorders
|
|
Earache
|
2 (0.7%)
|
1 (0.7%)
|
0
|
8 (2.9%)
|
2 (2.7%)
|
0
|
|
Nervous System Disorders
|
|
Headache
|
37 (13.9%)
|
12 (8.8%)
|
38 (11.3%)
|
69 (25.4%)
|
12 (16.0%)
|
23 (7.0%)
|
|
*Ages 2-17 years
|
DRUG INTERACTIONS
Potential interactions between Elidel and other drugs, including
immunizations, have not been systematically evaluated. Due to the very low blood
levels of pimecrolimus detected in some patients after topical application,
systemic drug interactions are not expected, but cannot be ruled out. The concomitant
administration of known CYP3A family of inhibitors in patients with widespread
and/or erythrodermic disease should be done with caution. Some examples of such
drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel
blockers and cimetidine.
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