ELIDEL

ELIDEL- pimecrolimus cream
Bausch Health US, LLC

WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED

Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream, 1%. [see Warnings and Precautions (5.1)]. Therefore:

Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis [see Dosage and Administration (2) , Warnings and Precautions (5.1)].
ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4)].

1 INDICATION AND USAGE

ELIDEL® (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION

Apply a thin layer of ELIDEL Cream, 1% to the affected skin twice daily. The patient should stop using ELIDEL Cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.

If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of ELIDEL Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis [see Warnings and Precautions (5.1)].

The safety of ELIDEL Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of ELIDEL Cream, 1% with occlusive dressings.

3 DOSAGE FORMS AND STRENGTHS

Cream, 1%.

Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base.

4 CONTRAINDICATIONS

ELIDEL Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Immunosuppression

Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.

Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream, 1%. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream, 1%. Therefore:

Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age.
ELIDEL Cream, 1% should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications.
If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed.
The safety of ELIDEL Cream, 1% has not been established beyond 1 year of non-continuous use.

5.2 Application to Malignant or Pre-malignant Skin Conditions

The use of ELIDEL Cream, 1% should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis.

ELIDEL Cream, 1% should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of ELIDEL Cream, 1% has not been established in patients with generalized erythroderma.

The use of ELIDEL Cream, 1% may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of ELIDEL Cream, 1% application and typically improve as the lesions of atopic dermatitis resolve [see Adverse Reactions (6.1)].

5.3 Bacterial and Viral Skin Infections

Before commencing treatment with ELIDEL Cream, 1%, bacterial or viral infections at treatment sites should be resolved. Trials have not evaluated the safety and efficacy of ELIDEL Cream, 1% in the treatment of clinically infected atopic dermatitis.

While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with ELIDEL Cream, 1% may be independently associated with an increased risk of varicella zoster virus infection (chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.

In clinical trials, 15/1544 (1%) cases of skin papilloma (warts) were observed in subjects using ELIDEL Cream, 1%. The youngest subject was age 2 and the oldest was age 12. In cases where there is worsening of skin papillomas or they do not respond to conventional therapy, discontinuation of ELIDEL Cream, 1% should be considered until complete resolution of the warts is achieved.

5.4 Patients with Lymphadenopathy

In clinical trials, 14/1544 (0.9%) cases of lymphadenopathy were reported while using ELIDEL Cream, 1%. These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. Patients who receive ELIDEL Cream, 1% and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL Cream, 1% should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

5.5 Sun Exposure

During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while ELIDEL Cream, 1% is not on the skin. The potential effects of ELIDEL Cream, 1% on skin response to ultraviolet damage are not known.

5.6 Immunocompromised Patients

The safety and efficacy of ELIDEL Cream, 1% in immunocompromised patients have not been studied.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

No phototoxicity and no photoallergenicity were detected in clinical trials with 24 and 33 normal volunteers, respectively. In human dermal safety trials, ELIDEL Cream, 1% did not induce contact sensitization or cumulative irritation.

In a 1-year safety trial in pediatric subjects age 2-17 years old involving sequential use of ELIDEL Cream, 1% and a topical corticosteroid, 43% of ELIDEL Cream, 1% treated subjects and 68% of vehicle-treated subjects used corticosteroids during the trial. Corticosteroids were used for more than 7 days by 34% of ELIDEL Cream, 1% treated subjects and 54% of vehicle-treated subjects. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the subjects that had used ELIDEL Cream, 1% and topical corticosteroid sequentially as compared to ELIDEL Cream, 1% alone.

In three randomized, double-blind vehicle-controlled pediatric trials and one active-controlled adult trial, 843 and 328 subjects, respectively, were treated with ELIDEL Cream, 1%. In these clinical trials, 48 (4%) of the 1171 ELIDEL Cream, 1% treated subjects and 13 (3%) of 408 vehicle-treated subjects 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 subjects treated with ELIDEL Cream, 1%.

Table 1 depicts the incidence of adverse events pooled across the two identically designed 6-week trials with their open label extensions and the 1-year safety trial for pediatric subjects ages 2-17. Data from the adult active-controlled trial are also included in Table 1. Adverse events are listed regardless of relationship to trial drug.

Table 1. Treatment Emergent Adverse Events (≥1%) in ELIDEL Cream, 1% Treatment Groups
Pediatric Subjects * Vehicle-Controlled Pediatric Subjects * Open-Label Pediatric Subjects * Vehicle-Controlled Adult Active Comparator
(6 weeks) (20 weeks) (1 year) (1 year)
ELIDEL Cream, 1% Vehicle ELIDEL Cream, 1% ELIDEL Cream, 1% Vehicle ELIDEL Cream, 1%
(N=267) N (%) (N=136)N (%) (N=335)N (%) (N=272)N (%) (N=75)N (%) (N=328)N (%)
*
Ages 2-17 years

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 and 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%)

Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL Cream, 1% (n = 2443). Causality has not been established.

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