ELIDEL (Pimecrolimus)

What is this medication?

Pimecrolimus, Elidel
Description: Calcineurin Inhibitor, Immunosuppressant

“ALERT: US Boxed Warning

Appropriate use:  Long-term safety of topical calcineurin inhibitors has not been established. Continuous long-term use of topical calcineurin inhibitors, including pimecrolimus, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.

Malignancy: Although a causal relationship has not been established, rare cases of malignancy (eg, skin malignancy, lymphoma) have been reported in patients treated with topical calcineurin inhibitors including pimecrolimus.

Pediatrics: Pimecrolimus is not indicated for use in children younger than 2 years.”

Officially indicated for the treatment of atopic dermatitis.

How does this medication work? 

Pimecrolimus, Elidel when applied topically will bind to macrophilin-12 (FKBP-12) and inhibit calcium-dependent phosphatase, calcineurin.  As a consequence, Pimecrolimus, Elidel blocks cytokine transcription and inhibits T-cell activation which will reduce the body’s immunogenic response to atopic dermatitis.

How should I take this medication? 

Atopic Dermatitis

Topical: Apply a thin layer to the affected area(s) twice daily.

How to Use Topical Pimecrolimus, Elidel:  Apply a thin layer to the affected area twice daily.  Do not cover the areas with an occlusive dressing.  A local sensation of burning and redness is very commonly experienced during the first days to week when using Elidel/Pimecrolimus.  Stop using when symptoms resolve and/or re-evaluate if symptoms still persist beyond 6 weeks. 

What should I watch for while using this medication? 

Higher risk of developing eczema herpeticum, varicella zoster, and herpes simplex

Associated with the development of lymphadenopathy, malignancy, skin papilloma

Do not use in immunocompromised patients

What if I miss a dose?

If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.

How should I store this medication?

Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication?

The most common adverse effects include the following when using topical Elidel/Pimecrolimus:

10%:

Central nervous system: Headache (children and adolescents 11% to 25%; adults 7%), fever (children and adolescents 13%; adults 1%)

Infection: Influenza (3% to 13%)

Local: Local burning (adults 26%; children and adolescents 2% to 8%; tends to resolve/improve as lesions resolve), application site reaction (adults 15%; children and adolescents 2%)

Respiratory: Nasopharyngitis (infants, children, and adolescents 10% to 27%; adults 8%), upper respiratory tract infection (children and adolescents 14% to 19%; adults 4%), cough (children and adolescents 9% to 16%; adults 2%), bronchitis (children and adolescents ≤11%; adults ≤2%)