Pimecrolimus Cream (Elidel)
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Pimecrolimus Cream (Elidel)

Elidel®
(pimecrolimus) Cream 1%

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

See WARNINGS, BOXED WARNING concerning long-term safety of topical calcineurin inhibitors.

DRUG DESCRIPTION

ELIDEL® (pimecrolimus) Cream 1% contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin.

Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1,14-dihydroxy-23,25 dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.0 4,9]octacos-18-ene2,3,10,16-tetraone.

The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.47. The structural formula is

Elidel® (pimecrolimus) Structural Formula Illustration

Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water.

Each gram of ELIDEL Cream 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

What are the possible side effects of pimecrolimus topical (Elidel)?

Stop using pimecrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pimecrolimus and call your doctor if you have:

  • worsened skin symptoms;
  • signs of a skin infection (redness, swelling, itching, oozing);
  • swollen glands; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur. Continue using pimecrolimus and talk with your doctor if you have any of these side...

Read All Potential Side Effects and See Pictures of Elidel »

What are the precautions when taking pimecrolimus cream (Elidel)?

Before using pimecrolimus, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections (e.g., mononucleosis), use of light therapy (e.g., UVA or UVB), skin infections (e.g., herpes, chickenpox, shingles, warts), immune system problems.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication should be used only when clearly needed during...

Read All Potential Precautions of Elidel »

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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 nonimmunocompromised 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 (pimecrolimus cream) Cream is not indicated for use in children less than 2 years of age (see WARNINGS, BOXED WARNING, and PRECAUTIONS, Pediatric Use).

DOSAGE AND ADMINISTRATION

  • The patient or care giver should apply a thin layer of ELIDEL (pimecrolimus) Cream 1% to the affected skin twice daily. The patient or caregiver should stop using 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 health care provider to confirm the diagnosis of atopic dermatitis.
  • Continuous long-term use of ELIDEL (pimecrolimus cream) Cream should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of ELIDEL (pimecrolimus cream) Cream under occlusion, which may promote systemic exposure, has not been evaluated. ELIDEL (pimecrolimus cream) Cream should not be used with occlusive dressings.

HOW SUPPLIED

ELIDEL® (pimecrolimus) Cream 1% is available in tubes of 30 grams, 60 grams, and 100 grams.

30 gram tube…………………NDC 0078-0375-46
60 gram tube……....…………NDC 0078-0375-49
100 gram tube………………..NDC 0078-0375-63

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Do not freeze.

Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, NJ 070936. Rev. July 2010

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL (pimecrolimus cream) Cream and a topical corticosteroid, 43% of ELIDEL (pimecrolimus cream) patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL (pimecrolimus cream) 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 (pimecrolimus cream) Cream and topical corticosteroid sequentially as compared to ELIDEL (pimecrolimus cream) 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 (pimecrolimus cream) Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL (pimecrolimus cream) 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 (pimecrolimus cream) 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® (pimecrolimus cream) Treatment Groups

  Pediatric Patients* Vehicle-Controlled (6weeks) Pediatric Patients* Open-Label (20 weeks) Pediatric Patients* Vehicle-Controlled (1year) Adult Active Comparator (1 year)
Elidel® (pimecrolimus cream) Cream
(N=267)
N (%)
Vehicle
(N=136)
N (%)
Elidel® (pimecrolimus cream) Cream
(N=335)
N (%)
Elidel® (pimecrolimus cream) Cream
(N=272)
N (%)
Vehicle
(N=75)
N (%)
Elidel® (pimecrolimus cream) Cream
(N=328)
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 Tissueand 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

Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL (pimecrolimus cream) Cream (n = 2,443). Causality has not been established.

Post-Marketing Events

The following adverse reactions have been reported in patients using ELIDEL (pimecrolimus cream) Cream. 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.

General

Anaphylactic reactions, ocular irritation after application of the cream to the eye lids or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol use, skin discoloration

Hematology/Oncology

Lymphomas, basal cell carcinoma, malignant melanoma, squamous cell carcinoma

Read the Elidel (pimecrolimus cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Potential interactions between ELIDEL (pimecrolimus cream) and other drugs, including immunizations, have not been systematically evaluated. Due to 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.

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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 (pimecrolimus cream) Cream.

Therefore:

  • Continuous long-term use of topical calcineurin inhibitors, including ELIDEL (pimecrolimus cream) Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
  • ELIDEL (pimecrolimus cream) Cream is not indicated for use in children less than 2 years of age.

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 (pimecrolimus cream) Cream. 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 (pimecrolimus cream) Cream. Therefore:

  • ELIDEL (pimecrolimus cream) Cream should not be used in immunocompromised adults and children.
  • 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 (see PRECAUTIONS).
  • The safety of ELIDEL (pimecrolimus cream) Cream has not been established beyond one year of noncontinuous use.

(See CLINICAL PHARMACOLOGY, WARNINGS, BOXED WARNING, PRECAUTIONS, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)

PRECAUTIONS

General

The use of ELIDEL (pimecrolimus cream) Cream 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 (pimecrolimus cream) Cream 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 (pimecrolimus cream) Cream has not been established in patients with generalized erythroderma.

The use of ELIDEL (pimecrolimus cream) Cream 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 (pimecrolimus cream) Cream application and typically improve as the lesions of atopic dermatitis resolve (see ADVERSE REACTIONS).

Bacterial and Viral Skin Infections

Before commencing treatment with ELIDEL (pimecrolimus cream) Cream, bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated the safety and efficacy of ELIDEL (pimecrolimus cream) Cream 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 (pimecrolimus cream) Cream may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum.

In clinical studies, 15/1,544 (1%) cases of skin papilloma (warts) were observed in patients using ELIDEL (pimecrolimus cream) Cream. The youngest patient 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 (pimecrolimus cream) Cream should be considered until complete resolution of the warts is achieved.

Patients with Lymphadenopathy

In clinical studies, 14/1,544 (0.9%) cases of lymphadenopathy were reported while using ELIDEL (pimecrolimus cream) Cream. 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 (pimecrolimus cream) Cream 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 (pimecrolimus cream) Cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.

Sun Exposure

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

Immunocompromised Patients

The safety and efficacy of ELIDEL (pimecrolimus cream) Cream in immunocompromised patients have not been studied.

Information for Patients

(See Medication Guide.)

Patients using ELIDEL (pimecrolimus cream) Cream should receive the following information and instructions:

What is the most important information a patient should know about ELIDEL (pimecrolimus cream) Cream?

The safety of using ELIDEL (pimecrolimus cream) Cream for a long period of time is not known. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have had cancer (for example, skin or lymphoma). However, a link with ELIDEL (pimecrolimus cream) Cream use has not been shown. Because of this concern:

  • A patient should not use ELIDEL (pimecrolimus cream) Cream continuously for a long time.
  • ELIDEL (pimecrolimus cream) Cream should be used only on areas of skin that have eczema.
  • ELIDEL (pimecrolimus cream) Cream is not for use on a child under 2 years old.

How should a patient use ELIDEL (pimecrolimus cream) Cream?

  • A patient should use ELIDEL (pimecrolimus cream) Cream exactly as prescribed.
  • A patient should use ELIDEL (pimecrolimus cream) Cream only on areas of skin that have eczema.
  • A patient should use ELIDEL (pimecrolimus cream) Cream for short periods, and if needed, treatment may be repeated with breaks in between.
  • A patient should stop ELIDEL (pimecrolimus cream) Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by the physician.
  • A patient should follow the physician's advice if symptoms of eczema return after a treatment with ELIDEL (pimecrolimus cream) Cream.
  • A patient should contact the physician if:
    • symptoms get worse with ELIDEL (pimecrolimus cream) Cream
    • the patient gets a skin infection
    • if burning on the skin is severe or lasts for more than one week
    • if eye irritation does not go away
    • symptoms do not improve after 6 weeks of treatment

To apply ELIDEL (pimecrolimus cream) Cream:

  • A patient or caregiver should wash their hands before using ELIDEL (pimecrolimus cream) Cream. When applying ELIDEL (pimecrolimus cream) Cream after a bath or shower, the skin should be dry.
  • A patient or caregiver should apply a thin layer of ELIDEL (pimecrolimus cream) Cream only to the affected skin areas, twice a day, as directed by the physician.
  • A patient or caregiver should use the smallest amount of ELIDEL (pimecrolimus cream) Cream needed to control the signs and symptoms of eczema.
  • Caregivers applying ELIDEL (pimecrolimus cream) Cream to a patient, or a patient who is not treating the hands should wash their hands with soap and water after applying ELIDEL (pimecrolimus cream) Cream. This should remove any cream left on the hands.
  • A patient should not bathe, shower or swim right after applying ELIDEL (pimecrolimus cream) Cream. This could wash off the cream.
  • A patient can use moisturizers with ELIDEL (pimecrolimus cream) Cream. They should be sure to check with the physician first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important they keep up good skin care practices. If a patient uses moisturizers, he or she should apply them after ELIDEL (pimecrolimus cream) Cream.

What should a patient avoid while using ELIDEL (pimecrolimus cream) Cream?

  • A patient should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL (pimecrolimus cream) Cream.
  • A patient should limit sun exposure during treatment with ELIDEL (pimecrolimus cream) Cream even when the medicine is not on the skin. If a patient needs to be outdoors after applying ELIDEL (pimecrolimus cream) Cream, the patient should wear loose fitting clothing that protects the treated area from the sun. The physician should advise the patient about other types of protection from the sun.
  • A patient should not cover the skin being treated with bandages, dressings or wraps. A patient can wear normal clothing.
  • ELIDEL (pimecrolimus cream) Cream is for use on the skin only. Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get ELIDEL (pimecrolimus cream) Cream in any of these areas, burning or irritation can happen. Wipe off any ELIDEL (pimecrolimus cream) Cream from the affected area and then rinse the area well with cold water. ELIDEL (pimecrolimus cream) Cream is for external use only.
  • A patient should not swallow ELIDEL (pimecrolimus cream) Cream and should contact the physician if they do.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year rat dermal carcinogenicity study using ELIDEL (pimecrolimus cream) Cream, a statistically significant increase in the incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male animals compared to vehicle and saline control male animals. Follicular cell adenoma of the thyroid was noted in the dermal rat carcinogenicity study at the lowest dose of 2 mg/kg/day [0.2% pimecrolimus cream; 1.5X the Maximum Recommended Human Dose (MRHD) based on AUC comparisons]. No increase in the incidence of follicular cell adenoma of the thyroid was noted in the oral carcinogenicity study in male rats up to 10 mg/kg/day (66X MRHD based on AUC comparisons). However, oral studies may not reflect continuous exposure or the same metabolic profile as by the dermal route. In a mouse dermal carcinogenicity study using pimecrolimus in an ethanolic solution, no increase in incidence of neoplasms was observed in the skin or other organs up to the highest dose of 4 mg/kg/day (0.32% pimecrolimus in ethanol) 27X MRHD based on AUC comparisons. However, lymphoproliferative changes (including lymphoma) were noted in a 13 week repeat dose dermal toxicity study conducted in mice using pimecrolimus in an ethanolic solution at a dose of 25 mg/kg/day (47X MRHD based on AUC comparisons). No lymphoproliferative changes were noted in this study at a dose of 10 mg/kg/day (17X MRHD based on AUC comparison). However, the latency time to lymphoma formation was shortened to 8 weeks after dermal administration of pimecrolimus dissolved in ethanol at a dose of 100 mg/kg/day (179-217X MRHD based on AUC comparisons).

In a mouse oral (gavage) carcinogenicity study, a statistically significant increase in the incidence of lymphoma was noted in high dose male and female animals compared to vehicle control male and female animals. Lymphomas were noted in the oral mouse carcinogenicity study at a dose of 45 mg/kg/day (258-340X MRHD based on AUC comparisons). No drug-related tumors were noted in the mouse oral carcinogenicity study at a dose of 15 mg/kg/day (60133X MRHD based on AUC comparisons). In an oral (gavage) rat carcinogenicity study, a statistically significant increase in the incidence of benign thymoma was noted in 10 mg/kg/day pimecrolimus treated male and female animals compared to vehicle control treated male and female animals. In addition, a significant increase in the incidence of benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day pimecrolimus treated male animals compared to vehicle control treated male animals. No drug-related tumors were noted in the rat oral carcinogenicity study at a dose of 1 mg/kg/day male animals (1.1X MRHD based on AUC comparisons) and at a dose of 5 mg/kg/day for female animals (21X MRHD based on AUC comparisons).

In a 52-week dermal photo-carcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with the ELIDEL (pimecrolimus cream) Cream vehicle alone. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, pimecrolimus, to the vehicle cream.

A 39-week oral monkey toxicology study was conducted with pimecrolimus doses of 15, 45 and 120 mg/kg/day. A dose dependent increase in expression of immunosuppressive-related lymphoproliferative disorder (IRLD) associated with lymphocryptovirus (a monkey strain of virus related to human Epstein Barr virus) was observed. IRLD in monkeys mirrors what has been noted in human transplant patients after chronic systemic immunosuppressive therapy, post transplantation lymphoproliferative disease (PTLD), after treatment with chronic systemic immunosuppressive therapy. Both IRLD and PTLD can progress to lymphoma, which is dependent on the dose and duration of systemic immunosuppressive therapy. A dose dependent increase in opportunistic infections (a signal of systemic immunosuppression) was also noted in this monkey study. A no observed adverse effect level (NOAEL) for IRLD and opportunistic infections was not established in this study. IRLD occurred at the lowest dose of 15 mg/kg/day for 39 weeks [31X the Maximum Recommended Human Dose (MRHD) of ELIDEL (pimecrolimus cream) Cream based on AUC comparisons] in this study. A partial recovery from IRLD was noted upon cessation of dosing in this study.

A battery of in vitro genotoxicity tests, including Ames assay, mouse lymphoma L5178Y assay, and chromosome aberration test in V79 Chinese hamster cells and an in vivo mouse micronucleus test revealed no evidence for a mutagenic or clastogenic potential for the drug.

An oral fertility and embryofetal developmental study in rats revealed estrus cycle disturbances, post-implantation loss and reduction in litter size at the 45 mg/kg/day dose (38X MRHD based on AUC comparisons). No effect on fertility in female rats was noted at 10 mg/kg/day (12X MRHD based on AUC comparisons). No effect on fertility in male rats was noted at 45 mg/kg/day (23X MRHD based on AUC comparisons), which was the highest dose tested in this study.

A second oral fertility and embryofetal developmental study in rats revealed reduced testicular and epididymal weights, reduced testicular sperm counts and motile sperm for males and estrus cycle disturbances, decreased corpora lutea, decreased implantations and viable fetuses for females at 45 mg/kg/day dose (123X MRHD for males and 192X MRHD for females based on AUC comparisons). No effect on fertility in female rats was noted at 10 mg/kg/day (5X MRHD based on AUC comparisons). No effect on fertility in male rats was noted at 2 mg/kg/day (0.7X MRHD based on AUC comparisons).

Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies of topically administered pimecrolimus in pregnant women. The experience with ELIDEL (pimecrolimus cream) Cream when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy.

In dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14X MRHD based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65X MRHD based on AUC comparisons). The 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and rabbits (gestational days 6-21 in rats and gestational days 6-20 in rabbits).

A second dermal embryofetal development study was conducted in rats using pimecrolimus cream applied dermally to pregnant rats (1 g cream/kg body weight of 0.2%, 0.6% and 1.0% pimecrolimus cream) from gestation day 6 to 17 at doses of 2, 6, and 10 mg/kg/day with daily exposure of approximately 22 hours. No maternal, reproductive, or embryo-fetal toxicity attributable to pimecrolimus was noted at 10 mg/kg/day (0.66X MRHD based on AUC comparisons), the highest dose evaluated in this study. No teratogenicity was noted in this study at any dose.

A combined oral fertility and embryofetal developmental study was conducted in rats and an oral embryofetal developmental study was conducted in rabbits. Pimecrolimus was administered during the period of organogenesis (2 weeks prior to mating until gestational day 16 in rats, gestational days 6-18 in rabbits) up to dose levels of 45 mg/kg/day in rats and 20 mg/kg/day in rabbits. In the absence of maternal toxicity, indicators of embryofetal toxicity (post-implantation loss and reduction in litter size) were noted at 45 mg/kg/day (38X MRHD based on AUC comparisons) in the oral fertility and embryofetal developmental study conducted in rats. No malformations in the fetuses were noted at 45 mg/kg/day (38X MRHD based on AUC comparisons) in this study. No maternal toxicity, embryotoxicity or teratogenicity were noted in the oral rabbit embryofetal developmental toxicity study at 20 mg/kg/day (3.9X MRHD based on AUC comparisons), which was the highest dose tested in this study.

A second oral embryofetal development study was conducted in rats. Pimecrolimus was administered during the period of organogenesis (gestational days 6 – 17) at doses of 2, 10 and 45 mg/kg/day. Maternal toxicity, embryolethality and fetotoxicity were noted at 45 mg/kg/day (271X MRHD based on AUC comparisons). A slight increase in skeletal variations that were indicative of delayed skeletal ossification was also noted at this dose. No maternal toxicity, embryolethality or fetotoxicity were noted at 10 mg/kg/day (16X MRHD based on AUC comparisons). No teratogenicity was noted in this study at any dose.

A second oral embryofetal development study was conducted in rabbits. Pimecrolimus was administered during the period of organogenesis (gestational days 7 – 20) at doses of 2, 6 and 20 mg/kg/day. Maternal toxicity, embryotoxicity and fetotoxicity were noted at 20 mg/kg/day (12X MRHD based on AUC comparisons). A slight increase in skeletal variations that were indicative of delayed skeletal ossification was also noted at this dose. No maternal toxicity, embryotoxicity or fetotoxicity were noted at 6 mg/kg/day (5X MRHD based on AUC comparisons). No teratogenicity was noted in this study at any dose.

An oral peri- and post-natal developmental study was conducted in rats. Pimecrolimus was administered from gestational day 6 through lactational day 21 up to a dose level of 40 mg/kg/day. Only 2 of 22 females delivered live pups at the highest dose of 40 mg/kg/day. Postnatal survival, development of the F1 generation, their subsequent maturation and fertility were not affected at 10 mg/kg/day (12X MRHD based on AUC comparisons), the highest dose evaluated in this study.

Pimecrolimus was transferred across the placenta in oral rat and rabbit embryofetal developmental studies.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly needed during pregnancy.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

ELIDEL (pimecrolimus cream) Cream is not indicated for use in children less than 2 years of age.

The long-term safety and effects of ELIDEL (pimecrolimus cream) Cream on the developing immune system are unknown (see WARNINGS, BOXED WARNING, and INDICATIONS AND USAGE).

Three Phase 3 pediatric studies were conducted involving 1,114 patients 2-17 years of age. Two studies were 6-week randomized vehicle-controlled studies with a 20-week open-label phase and one was a vehicle-controlled (up to 1 year) safety study with the option for sequential topical corticosteroid use. Of these patients 542 (49%) were 2-6 years of age. In the short-term studies, 11% of ELIDEL (pimecrolimus cream) patients did not complete these studies and 1.5% of ELIDEL (pimecrolimus cream) patients discontinued due to adverse events. In the one-year study, 32% of ELIDEL (pimecrolimus cream) patients did not complete this study and 3% of ELIDEL (pimecrolimus cream) patients discontinued due to adverse events. Most discontinuations were due to unsatisfactory therapeutic effect.

The most common local adverse event in the short-term studies of ELIDEL (pimecrolimus cream) Cream in pediatric patients ages 2-17 was application site burning (10% vs. 13% vehicle); the incidence in the long-term study was 9% ELIDEL vs. 7% vehicle (see ADVERSE REACTIONS). Adverse events that were more frequent ( > 5%) in patients treated with ELIDEL (pimecrolimus cream) Cream compared to vehicle were headache (14% vs. 9%) in the short-term trial. Nasopharyngitis (26% vs. 21%), influenza (13% vs. 4%), pharyngitis (8% vs. 3%), viral infection (7% vs. 1%), pyrexia (13% vs. 5%), cough (16% vs. 11%), and headache (25% vs. 16%) were increased over vehicle in the 1-year safety study (see ADVERSE REACTIONS). In 843 patients ages 2-17 years treated with ELIDEL (pimecrolimus cream) Cream, 9 (0.8%) developed eczema herpeticum (5 on ELIDEL (pimecrolimus cream) Cream alone and 4 on ELIDEL (pimecrolimus cream) Cream used in sequence with corticosteroids). In 211 patients on vehicle alone, there were no cases of eczema herpeticum. The majority of adverse events were mild to moderate in severity.

Two Phase 3 studies were conducted involving 436 infants age 3 months-23 months. One 6week randomized vehicle-controlled study with a 20-week open-label phase and one safety study, up to one year, were conducted. In the 6-week study, 11% of ELIDEL (pimecrolimus cream) and 48% of vehicle patients did not complete this study; no patient in either group discontinued due to adverse events. Infants on ELIDEL (pimecrolimus cream) Cream had an increased incidence of some adverse events compared to vehicle. In the 6-week vehicle-controlled study these adverse events included pyrexia (32% vs. 13% vehicle), URI (24% vs. 14%), nasopharyngitis (15% vs. 8%), gastroenteritis (7% vs. 3%), otitis media (4% vs. 0%), and diarrhea (8% vs. 0%). In the open-label phase of the study, for infants who switched to ELIDEL (pimecrolimus cream) Cream from vehicle, the incidence of the above-cited adverse events approached or equaled the incidence of those patients who remained on ELIDEL (pimecrolimus cream) Cream. In the 6 month safety data, 16% of ELIDEL (pimecrolimus cream) and 35% of vehicle patients discontinued early and 1.5% of ELIDEL (pimecrolimus cream) and 0% of vehicle patients discontinued due to adverse events. Infants on ELIDEL (pimecrolimus cream) Cream had a greater incidence of some adverse events as compared to vehicle. These included pyrexia (30% vs. 20%), URI (21% vs. 17%), cough (15% vs. 9%), hypersensitivity (8% vs. 2%), teething (27% vs. 22%), vomiting (9% vs. 4%), rhinitis (13% vs. 9%), viral rash (4% vs. 0%), rhinorrhea (4% vs. 0%), and wheezing (4% vs. 0%).

Geriatric Use

Nine (9) patients ≥ 65 years old received ELIDEL (pimecrolimus cream) Cream in Phase 3 studies. Clinical studies of ELIDEL (pimecrolimus cream) did not include sufficient numbers of patients aged 65 and over to assess efficacy and safety.

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There has been no experience of overdose with ELIDEL® (pimecrolimus) Cream 1%. If oral ingestion occurs, medical advice should be sought.

CONTRAINDICATIONS

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

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action/Pharmacodynamics

The mechanism of action of pimecrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. In addition, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.

Pharmacokinetics

Absorption

In adult patients (n=52) being treated for atopic dermatitis [13%-62% Body Surface Area (BSA) involvement] for periods up to a year, a maximum pimecrolimus concentration of 1.4 ng/mL was observed among those subjects with detectable blood levels. In the majority of samples in adult (91%; 1,244/1,362) subjects, blood concentrations of pimecrolimus were below 0.5 ng/mL. Data on blood levels of pimecrolimus measured in pediatric patients are described below in Special Populations, Pediatrics.

Distribution

Laboratory in vitro plasma protein binding studies using equilibrium gel filtration have shown that 99.5% of pimecrolimus in plasma is bound to proteins over the pimecrolimus concentration range of 2-100 ng/mL tested. The major fraction of pimecrolimus in plasma appears to be bound to various lipoproteins. As with other topical calcineurin inhibitors, it is not known whether pimecrolimus is absorbed into cutaneous lymphatic vessels or in regional lymph nodes.

Metabolism

Following the administration of a single oral radiolabeled dose of pimecrolimus numerous circulating O-demethylation metabolites were seen. Studies with human liver microsomes indicate that pimecrolimus is metabolized in vitro by the CYP3A sub-family of metabolizing enzymes. No evidence of skin mediated drug metabolism was identified in vivo using the minipig or in vitro using stripped human skin.

Elimination

Based on the results of the aforementioned radiolabeled study, following a single oral dose of pimecrolimus ~81% of the administered radioactivity was recovered, primarily in the feces (78.4%) as metabolites. Less than 1% of the radioactivity found in the feces was due to unchanged pimecrolimus.

Special Populations

Pediatrics

The systemic exposure to pimecrolimus from ELIDEL® (pimecrolimus) Cream 1% was investigated in 28 pediatric patients with atopic dermatitis (20%-80% BSA involvement) between the ages of 8 months-14 yrs. Following twice daily application for three weeks, blood concentrations of pimecrolimus were < 2 ng/mL with 60% (96/161) of the blood samples having blood concentration below the limit of quantification (0.5 ng/mL). However, the children (23 children out of the total 28 children investigated) had at least one detectable blood level as compared to the adults (12 adults out of the total 52 adults investigated) over a 3-week treatment period. Due to the erratic nature of the blood levels observed, no correlation could be made between amount of cream, degree of BSA involvement, and blood concentrations. In general, the blood concentrations measured in adult atopic dermatitis patients were comparable to those seen in the pediatric population.

In a second group of 30 pediatric patients aged 3-23 months with 10%-92% BSA involvement, following twice daily application for three weeks, blood concentrations of pimecrolimus were < 2.6 ng/mL with 65% (75/116) of the blood samples having blood concentration below 0.5ng/mL, and 27% (31/116) below the limit of quantification (0.1 ng/mL) for these studies.

Overall, a higher proportion of detectable blood levels was seen in the pediatric patient population as compared to adult population. This increase in the absolute number of positive blood levels may be due to the larger surface area to body mass ratio seen in these younger subjects. In addition, a higher incidence of upper respiratory symptoms/infections was also seen relative to the older age group in the PK studies. At this time, a causal relationship between these findings and ELIDEL (pimecrolimus cream) use cannot be ruled out.

ELIDEL (pimecrolimus cream) Cream is not indicated for use in children less than 2 years of age (see INDICATIONS AND USAGE, WARNINGS, BOXED WARNING, and PRECAUTIONS, Pediatric Use).

Renal Insufficiency

The effect of renal insufficiency on the pharmacokinetics of topically administered pimecrolimus has not been evaluated but dose-adjustment is not expected to be needed as 80% of the drug is excreted in the feces.

Hepatic Insufficiency

The effect of hepatic insufficiency on the pharmacokinetics of topically administered pimecrolimus has not been evaluated but dose-adjustment is not expected to be needed.

Clinical Studies

Three randomized, double-blind, vehicle-controlled, multi-center, Phase 3 studies were conducted in 589 pediatric patients ages 3 months-17 years old to evaluate ELIDEL® (pimecrolimus) Cream 1% for the treatment of mild to moderate atopic dermatitis. Two of the three trials support the use of ELIDEL (pimecrolimus cream) Cream in patients 2 years and older with mild to moderate atopic dermatitis (see PRECAUTIONS, Pediatric Use). Three other trials in 1,619 pediatric and adult patients provided additional data regarding the safety of ELIDEL (pimecrolimus cream) Cream in the treatment of atopic dermatitis. Two of these other trials were vehicle-controlled with optional sequential use of a medium potency topical corticosteroid in pediatric patients and one trial was an active comparator trial in adult patients with atopic dermatitis (see PRECAUTIONS, Pediatric Use and ADVERSE REACTIONS).

Two identical 6-week, randomized, vehicle-controlled, multi-center, Phase 3 trials were conducted to evaluate ELIDEL (pimecrolimus cream) Cream for the treatment of mild to moderate atopic dermatitis. A total of 403 pediatric patients 2-17 years old were included in the studies. The male/female ratio was approximately 50% and 29% of the patients were African American. At study entry, 59% of patients had moderate disease and the mean body surface area (BSA) affected was 26%. About 75% of patients had atopic dermatitis affecting the face and/or neck region. In these studies, patients applied either ELIDEL (pimecrolimus cream) Cream or vehicle cream twice daily to 5% to 96% of their BSA for up to 6 weeks. At endpoint, based on the physician's global evaluation of clinical response, 35% of patients treated with ELIDEL (pimecrolimus cream) Cream were clear or almost clear of signs of atopic dermatitis compared to only 18% of vehicle-treated patients. More ELIDEL (pimecrolimus cream) patients (57%) had mild or no pruritus at 6 weeks compared to vehicle patients (34%). The improvement in pruritus occurred in conjunction with the improvement of the patients' atopic dermatitis.

In these two 6-week studies of ELIDEL (pimecrolimus cream) , the combined efficacy results at endpoint are as follows:

  % Patients
Elidel® (N= 267) Vehicle (N= 136)
Global Assessment
Clear 28 (10%) 5 (4%)
Clear or Almost Clear 93 (35%) 25 (18%)
Clear to Mild Disease 180 (67%) 55 (40%)

In the two pediatric studies that independently support the use of ELIDEL (pimecrolimus cream) Cream in mild to moderate atopic dermatitis, a significant treatment effect was seen by day 15. Of the key signs of atopic dermatitis, erythema, infiltration/papulation, lichenification, and excoriations, erythema and infiltration/papulation were reduced at day 8 when compared to vehicle.

The following graph depicts the time course of improvement in the percent body surface area affected as a result of treatment with ELIDEL (pimecrolimus cream) Cream in 2-17 year olds.

Figure 1

Body surface area over time - Illustration

The following graph shows the time course of improvement in erythema as a result of treatment with ELIDEL (pimecrolimus cream) Cream in 2-17 year olds.

Figure 2

Mean erythema over time - illustration

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

ELIDEL®
[EL-ee-del]
(pimecrolimus) Cream 1%

Important Note: ELIDEL (pimecrolimus cream) Cream is for use on the skin only (topical). Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum.

Read the Medication Guide that comes with ELIDEL (pimecrolimus cream) Cream before you or a family member start using it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about ELIDEL (pimecrolimus cream) Cream, ask your doctor or pharmacist.

What is the most important information I should know about ELIDEL (pimecrolimus cream) Cream?

It is not known if ELIDEL (pimecrolimus cream) Cream is safe to use for a long period of time. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have gotten cancer (for example, skin cancer or lymphoma). But a link that ELIDEL (pimecrolimus cream) Cream caused these cancers use has not been shown. Because of this concern:

  • Do not use ELIDEL (pimecrolimus cream) Cream continuously for a long time.
  • Use ELIDEL (pimecrolimus cream) Cream only on areas of your skin that have eczema.
  • Do not use ELIDEL (pimecrolimus cream) Cream on a child under 2 years old.

What is ELIDEL (pimecrolimus cream) Cream?

ELIDEL (pimecrolimus cream) Cream is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). ELIDEL (pimecrolimus cream) Cream is in a class of medicines called topical calcineurin inhibitors. ELIDEL (pimecrolimus cream) Cream is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL (pimecrolimus cream) Cream is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL (pimecrolimus cream) Cream is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.

It is not known if ELIDEL (pimecrolimus cream) Cream is safe and effective in people who have a weakened immune system.

ELIDEL (pimecrolimus cream) Cream is not for use in children under 2 years of age.

Who should not use ELIDEL (pimecrolimus cream) Cream?

Do not use ELIDEL (pimecrolimus cream) Cream:

  • if you are allergic to ELIDEL (pimecrolimus cream) Cream or anything in it. See the end of this Medication Guide for a complete list of ingredients in ELIDEL (pimecrolimus cream) Cream.

What should I tell my doctor before starting ELIDEL (pimecrolimus cream) Cream?

Before you start using ELIDEL (pimecrolimus cream) Cream, tell your doctor about all of your medical conditions, including if you:

  • have a skin disease called Netherton's syndrome (a rare inherited condition)
  • have any infection on your skin including chicken pox or herpes
  • have been told you have a weakened immune system
  • are pregnant, breastfeeding, or planning to become pregnant.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I use ELIDEL (pimecrolimus cream) Cream?

  • Use ELIDEL (pimecrolimus cream) Cream exactly as prescribed.
  • Use ELIDEL (pimecrolimus cream) Cream only on areas of your skin that have eczema.
  • Use ELIDEL (pimecrolimus cream) Cream for short periods, and if needed, treatment may be repeated with breaks in between.
  • Stop ELIDEL (pimecrolimus cream) Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
  • Follow your doctor's advice if symptoms of eczema return after a treatment with ELIDEL (pimecrolimus cream) Cream.
  • Call your doctor if:
    • your symptoms get worse with ELIDEL (pimecrolimus cream) Cream
    • you get an infection on your skin
    • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply ELIDEL (pimecrolimus cream) Cream:

Read and carefully follow the directions below.

  • Wash your hands before using ELIDEL (pimecrolimus cream) Cream. If you apply ELIDEL (pimecrolimus cream) Cream after a bath or shower, make sure your skin is dry.
  • Apply a thin layer of ELIDEL (pimecrolimus cream) Cream only to the affected skin areas, two times each day, as directed by your doctor.
  • Use the smallest amount of ELIDEL (pimecrolimus cream) Cream needed to control the signs and symptoms of eczema.
  • If you apply ELIDEL (pimecrolimus cream) Cream to another person, or if you have eczema and are not treating your hands, it is important for you to wash your hands with soap and water after applying ELIDEL (pimecrolimus cream) Cream. This should remove any cream left on your hands.
  • Do not bathe, shower or swim right after applying ELIDEL (pimecrolimus cream) Cream. This could wash off the cream.
  • You can use moisturizers with ELIDEL (pimecrolimus cream) Cream. Make sure you check with your doctor first about the products that are right for you. People with eczema can have very dry skin, so it is important to keep up good skin care practices. If you use moisturizers, apply them after ELIDEL (pimecrolimus cream) Cream.

What should I avoid while using ELIDEL (pimecrolimus cream) Cream?

  • You should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL (pimecrolimus cream) Cream.
  • Limit your time in the sun during treatment with ELIDEL (pimecrolimus cream) Cream even when the medicine is not on your skin. If you need to be outdoors after applying ELIDEL (pimecrolimus cream) Cream, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use. It is not known how ELIDEL (pimecrolimus cream) Cream may affect your skin with exposure to ultraviolet light.
  • Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
  • ELIDEL (pimecrolimus cream) Cream is for use on the skin only. Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get ELIDEL (pimecrolimus cream) Cream in any of these areas, burning or irritation can happen. Wipe off any ELIDEL (pimecrolimus cream) Cream from the affected area and then rinse the area well with cold water.
  • Do not swallow ELIDEL (pimecrolimus cream) Cream. If you do, call your doctor.
  • Avoid using ELIDEL (pimecrolimus cream) Cream on skin areas that have cancers or pre-cancers.

What are the possible side effects of ELIDEL (pimecrolimus cream) Cream?

ELIDEL (pimecrolimus cream) Cream may cause serious side effects. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have gotten cancer (for example, skin cancer or lymphoma). But, a link that ELIDEL (pimecrolimus cream) Cream caused these cancers has not been shown.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects include headache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Tell your doctor if you have a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with ELIDEL (pimecrolimus cream) Cream. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store ELIDEL (pimecrolimus cream) Cream?

  • Store ELIDEL (pimecrolimus cream) Cream at room temperature between 59° to 86°F (15° to 30°C).
  • Keep ELIDEL (pimecrolimus cream) Cream and all medicines out of the reach of children.

General advice about ELIDEL (pimecrolimus cream) Cream

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ELIDEL (pimecrolimus cream) Cream only for the condition for which it was prescribed. Do not give ELIDEL (pimecrolimus cream) Cream to other people even if they have the same symptoms you have, as it may not be right for them.

This Medication Guide summarizes the most important information about ELIDEL (pimecrolimus cream) Cream. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about ELIDEL (pimecrolimus cream) Cream that is written for health care professionals. For more information, you can also visit the Novartis Internet site at www.elidel (pimecrolimus cream) .com or call the ELIDEL (pimecrolimus cream) Cream help line at 877-4 ELIDEL (pimecrolimus cream) (877-435-4335).

What are the ingredients in ELIDEL Cream?

Active ingredient: pimecrolimus

Inactive ingredients: benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide

ELIDEL®
[EL-ee-del]
(pimecrolimus) Cream 1%

Important Note: ELIDEL (pimecrolimus cream) Cream is for use on the skin only (topical). Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum.

Read the Medication Guide that comes with ELIDEL (pimecrolimus cream) Cream before you or a family member start using it and each time you refill your prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about ELIDEL (pimecrolimus cream) Cream, ask your doctor or pharmacist.

What is the most important information I should know about ELIDEL (pimecrolimus cream) Cream?

It is not known if ELIDEL (pimecrolimus cream) Cream is safe to use for a long period of time. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have gotten cancer (for example, skin cancer or lymphoma). But a link that ELIDEL (pimecrolimus cream) Cream caused these cancers use has not been shown. Because of this concern:

  • Do not use ELIDEL (pimecrolimus cream) Cream continuously for a long time.
  • Use ELIDEL (pimecrolimus cream) Cream only on areas of your skin that have eczema.
  • Do not use ELIDEL (pimecrolimus cream) Cream on a child under 2 years old.

What is ELIDEL (pimecrolimus cream) Cream?

ELIDEL (pimecrolimus cream) Cream is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). ELIDEL (pimecrolimus cream) Cream is in a class of medicines called topical calcineurin inhibitors. ELIDEL (pimecrolimus cream) Cream is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL (pimecrolimus cream) Cream is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL (pimecrolimus cream) Cream is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.

It is not known if ELIDEL (pimecrolimus cream) Cream is safe and effective in people who have a weakened immune system.

ELIDEL (pimecrolimus cream) Cream is not for use in children under 2 years of age.

Who should not use ELIDEL (pimecrolimus cream) Cream?

Do not use ELIDEL (pimecrolimus cream) Cream:

  • if you are allergic to ELIDEL (pimecrolimus cream) Cream or anything in it. See the end of this Medication Guide for a complete list of ingredients in ELIDEL (pimecrolimus cream) Cream.

What should I tell my doctor before starting ELIDEL (pimecrolimus cream) Cream?

Before you start using ELIDEL (pimecrolimus cream) Cream, tell your doctor about all of your medical conditions, including if you:

  • have a skin disease called Netherton's syndrome (a rare inherited condition)
  • have any infection on your skin including chicken pox or herpes
  • have been told you have a weakened immune system
  • are pregnant, breastfeeding, or planning to become pregnant.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How should I use ELIDEL (pimecrolimus cream) Cream?

  • Use ELIDEL (pimecrolimus cream) Cream exactly as prescribed.
  • Use ELIDEL (pimecrolimus cream) Cream only on areas of your skin that have eczema.
  • Use ELIDEL (pimecrolimus cream) Cream for short periods, and if needed, treatment may be repeated with breaks in between.
  • Stop ELIDEL (pimecrolimus cream) Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
  • Follow your doctor's advice if symptoms of eczema return after a treatment with ELIDEL (pimecrolimus cream) Cream.
  • Call your doctor if:
    • your symptoms get worse with ELIDEL (pimecrolimus cream) Cream
    • you get an infection on your skin
    • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply ELIDEL (pimecrolimus cream) Cream:

Read and carefully follow the directions below.

  • Wash your hands before using ELIDEL (pimecrolimus cream) Cream. If you apply ELIDEL (pimecrolimus cream) Cream after a bath or shower, make sure your skin is dry.
  • Apply a thin layer of ELIDEL (pimecrolimus cream) Cream only to the affected skin areas, two times each day, as directed by your doctor.
  • Use the smallest amount of ELIDEL (pimecrolimus cream) Cream needed to control the signs and symptoms of eczema.
  • If you apply ELIDEL (pimecrolimus cream) Cream to another person, or if you have eczema and are not treating your hands, it is important for you to wash your hands with soap and water after applying ELIDEL (pimecrolimus cream) Cream. This should remove any cream left on your hands.
  • Do not bathe, shower or swim right after applying ELIDEL (pimecrolimus cream) Cream. This could wash off the cream.
  • You can use moisturizers with ELIDEL (pimecrolimus cream) Cream. Make sure you check with your doctor first about the products that are right for you. People with eczema can have very dry skin, so it is important to keep up good skin care practices. If you use moisturizers, apply them after ELIDEL (pimecrolimus cream) Cream.

What should I avoid while using ELIDEL (pimecrolimus cream) Cream?

  • You should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with ELIDEL (pimecrolimus cream) Cream.
  • Limit your time in the sun during treatment with ELIDEL (pimecrolimus cream) Cream even when the medicine is not on your skin. If you need to be outdoors after applying ELIDEL (pimecrolimus cream) Cream, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use. It is not known how ELIDEL (pimecrolimus cream) Cream may affect your skin with exposure to ultraviolet light.
  • Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
  • ELIDEL (pimecrolimus cream) Cream is for use on the skin only. Do not get ELIDEL (pimecrolimus cream) Cream in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get ELIDEL (pimecrolimus cream) Cream in any of these areas, burning or irritation can happen. Wipe off any ELIDEL (pimecrolimus cream) Cream from the affected area and then rinse the area well with cold water.
  • Do not swallow ELIDEL (pimecrolimus cream) Cream. If you do, call your doctor.
  • Avoid using ELIDEL (pimecrolimus cream) Cream on skin areas that have cancers or pre-cancers.

What are the possible side effects of ELIDEL (pimecrolimus cream) Cream?

ELIDEL (pimecrolimus cream) Cream may cause serious side effects. A very small number of people who have used ELIDEL (pimecrolimus cream) Cream have gotten cancer (for example, skin cancer or lymphoma). But, a link that ELIDEL (pimecrolimus cream) Cream caused these cancers has not been shown.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects include headache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Tell your doctor if you have a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with ELIDEL (pimecrolimus cream) Cream. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store ELIDEL (pimecrolimus cream) Cream?

  • Store ELIDEL (pimecrolimus cream) Cream at room temperature between 59° to 86°F (15° to 30°C).
  • Keep ELIDEL (pimecrolimus cream) Cream and all medicines out of the reach of children.

General advice about ELIDEL (pimecrolimus cream) Cream

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ELIDEL (pimecrolimus cream) Cream only for the condition for which it was prescribed. Do not give ELIDEL (pimecrolimus cream) Cream to other people even if they have the same symptoms you have, as it may not be right for them.

This Medication Guide summarizes the most important information about ELIDEL (pimecrolimus cream) Cream. If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about ELIDEL (pimecrolimus cream) Cream that is written for health care professionals. For more information, you can also visit the Novartis Internet site at www.elidel (pimecrolimus cream) .com or call the ELIDEL (pimecrolimus cream) Cream help line at 877-4 ELIDEL (pimecrolimus cream) (877-435-4335).

What are the ingredients in ELIDEL Cream?

Active ingredient: pimecrolimus

Inactive ingredients: benzyl alcohol, cetyl alcohol, citric acid, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides, and water.

Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Elidel Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PIMECROLIMUS - TOPICAL

(pim-eck-row-LEE-muss)

COMMON BRAND NAME(S): Elidel

WARNING: Patients have benefited from use of pimecrolimus when it is used correctly. Long-term safety for this drug is not known at this time. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using pimecrolimus. It is not known whether pimecrolimus caused these cancers when used on the skin. Further studies to determine the long-term safety of this product are ongoing. In the unlikely event that unusual lumps, swollen glands, or growths (especially on the skin) occur, contact your doctor immediately.

The FDA recommends the following: This drug should be used only if other drugs have failed or if other medications are not considered appropriate by your doctor. Pimecrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between. Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Also, this medication should not be used in children younger than 2 years. As with all medications, discuss the risks, benefits, and proper use of this medication with your doctor.

USES: Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (e.g., topical steroids). Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by changing the skin's defense (immune) system, thereby decreasing the allergic reaction that causes eczema. Pimecrolimus belongs to a class of drugs known as topical calcineurin inhibitors (TCIs).

This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton's syndrome). Also, this medication should not be used by anyone who has a weakened immune system (e.g., following an organ transplant).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using pimecrolimus and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Wash your hands with soap and water before using this medication. Apply a thin layer to the affected areas of skin, usually twice daily or as directed by your doctor. Rub the medication into the skin gently and completely. Wash your hands after using this product unless your hands are being treated. If your doctor recommends a moisturizer, apply it after this medication.

Pimecrolimus is for use on the skin only. Avoid getting this medication in your eyes or on the inside of your nose or mouth. Do not apply this medication to open wounds or infected areas. Do not cover the treated area with plastic or waterproof bandages unless directed to do so by your doctor. Do not bathe, shower or swim right after applying this medication.

Use this medication exactly as directed. Your doctor may instruct you to stop using it once your eczema has cleared up and to start using it again if signs or symptoms reappear. Consult your doctor for details.

Inform your doctor if your condition does not improve after 6 weeks of using this medication or if your condition worsens at any time.

Disclaimer

Elidel Consumer (continued)

SIDE EFFECTS: Mild burning or irritation at the application site may occur during the first few days of treatment. Headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if the following unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Elidel (pimecrolimus cream) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using pimecrolimus, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections (e.g., mononucleosis), use of light therapy (e.g., UVA or UVB), skin infections (e.g., herpes, chickenpox, shingles, warts), immune system problems.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Elidel Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: topical steroids, other ointments/lotions/creams.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medication may be harmful if swallowed.

NOTES: Do not share this medication with others. This drug should be used as directed for treating your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Keep all medical appointments while you are using this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual application schedule.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze.

Make sure the cap on the tube is tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2010. Copyright(c) 2010 First Databank, Inc.

Elidel Patient Information Including Side Effects

Brand Names: Elidel

Generic Name: pimecrolimus topical (Pronunciation: pih meh KRA lih muss TOP ik al)

What is pimecrolimus topical (Elidel)?

Pimecrolimus is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.

Pimecrolimus topical is used to treat severe atopic dermatitis when other medications have not worked well.

Pimecrolimus may also be used for purposes other than those listed here.

What are the possible side effects of pimecrolimus topical (Elidel)?

Stop using pimecrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using pimecrolimus and call your doctor if you have:

  • worsened skin symptoms;
  • signs of a skin infection (redness, swelling, itching, oozing);
  • swollen glands; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur. Continue using pimecrolimus and talk with your doctor if you have any of these side effects:

  • burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);
  • swollen hair follicles;
  • acne or warts;
  • upset stomach;
  • muscle pain;
  • runny or stuffy nose;
  • headache; or
  • feeling more sensitive to hot or cold temperatures.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Elidel (pimecrolimus cream) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pimecrolimus topical (Elidel)?

Do not use pimecrolimus topical on a child 2 years of age or younger.

A small number of people have developed skin cancer after using tacrolimus (Protopic) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Pimecrolimus is not for long-term use.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with pimecrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.

Talk to your doctor if your skin condition does not improve after using pimecrolimus topical for 6 weeks.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs or skin products that can affect pimecrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Side Effects Centers

Elidel Patient Information including How Should I Take

What should I discuss with my healthcare provider before using pimecrolimus topical (Elidel)?

Before using pimecrolimus topical, tell your doctor if you have:

  • skin cancer or a skin infection (including herpes or chicken pox);
  • Netherton's syndrome (a genetic skin disorder);
  • a weak immune system (from cancer treatments, HIV/AIDS or certain medicines such as steroids);
  • kidney disease; or
  • swelling, redness, or irritation of large areas of your skin.

If you have any of these conditions, you may not be able to use pimecrolimus or you may need a dosage adjustment or special tests during treatment.

Pimecrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus such as chicken pox or herpes (cold sores or shingles). Tell your doctor if you have been exposed to any illness.

FDA pregnancy category C: This medication may be harmful to an unborn baby. Do not use pimecrolimus without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment.

Pimecrolimus passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

A small number of people have developed skin cancer after using pimecrolimus or tacrolimus (Protopic) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

How should I use pimecrolimus topical (Elidel)?

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Pimecrolimus is not for long-term use.

Do not use pimecrolimus topical on a child 2 years of age or younger.

Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise.

Wash your hands before and after using pimecrolimus, unless you are using the medication to treat a hand condition.

Apply the medicine only to clean, dry skin. Use the smallest amount needed to apply a thin layer to the skin areas diagnosed with atopic dermatitis. Rub in gently. Do not cover the treated skin with a bandage.

Do not bathe, shower, or swim right after applying pimecrolimus topical. Water may wash off the medicine.

Right after applying pimecrolimus, you may need to rub in a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.

Talk to your doctor if your skin condition does not improve after using pimecrolimus topical for 6 weeks.

Store pimecrolimus topical at room temperature. Do not freeze. Keep the cap on the cream tube when not in use.

Side Effects Centers

Elidel Patient Information including If I Miss a Dose

What happens if I miss a dose (Elidel)?

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Elidel)?

Seek emergency medical attention if you think you have used too much of this medicine. Pimecrolimus is not expected to cause overdose symptoms.

What should I avoid while using pimecrolimus topical (Elidel)?

Avoid using any other skin product that has not been recommended by your doctor.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with pimecrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.

Avoid drinking alcohol. Drinking alcohol while you are using pimecrolimus topical may cause your skin or face to feel hot and become flushed or red.

What other drugs will affect pimecrolimus topical (Elidel)?

Before using pimecrolimus topical, tell your doctor if you are using any of the following drugs:

  • cimetidine (Tagamet).
  • erythromycin (Ery-Tab, E-Mycin, E.E.S. and others);
  • an antifungal medicine such as ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan); or
  • a heart medicine such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene).

There may be other drugs or skin products that can affect pimecrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has additional information about pimecrolimus topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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