Medication
Topical Calcineurin Inhibitors (TCIs)

Used to treat:

Atopic dermatitis

What it does: When applied to the skin, pimecrolimus and tacrolimus effectively reduce inflammation along with other signs and symptoms.

How to use: The recommended dosage for both pimecrolimus and tacrolimus is to apply a thin layer twice a day to the affected skin as directed. Both medications are usually prescribed for a limited time.

Neither medication should be used if a patient has:

  • A weakened immune system

  • A skin infection, including chicken pox or herpes

  • Netherton’s syndrome, a rare inherited skin condition

While using a topical calcineurin inhibitor, the following precautions should be taken:

  • Avoid sunlight and other UV exposure: Patients should avoid exposure to sunlight, tanning beds, sun lamps, and treatment with ultraviolet (UV) light while taking these medications.

    Sun protection is essential. Be sure to avoid the midday (between 10 a.m. and 4 p.m.) sun. Even when going outdoors for a few minutes, follow sun-protection practices. Wear loose-fitting clothing that protects the treated area from sunlight, apply a sunscreen with a Sun Protection Factor (SPF) of 30 or higher to all exposed skin 20 minutes before going outdoors, use a lip protectant that has an SPF of at least 30, and wear a wide-brimmed hat and sunglasses.

  • Tell your dermatologist if you are pregnant or breast-feeding. Women who are pregnant, breast-feeding, or may become pregnant should discuss safety with their dermatologist. Research shows that the oral form of tacrolimus crosses the placenta and appears in breast milk, making it inappropriate for use by pregnant or breast-feeding women.

In clinical trials, side effects have been mild and temporary. Some patients using pimecrolimus experience a mild to moderate temporary sensation of warmth or burning on the skin when the medication is applied. Other side effects include headache and cold-like symptoms. When applying tacrolimus, some patients experience stinging and burning when the ointment touches the skin.

The more severe the eczema, the more likely the patient is to experience these side effects. The burning sensation is usually limited to the area being treated and tends to subside after the first week


About the Black Box Warning
In 2006, the FDA added a black box warning to topical pimecrolimus cream and topical tacrolimus ointment. The warning states that use of these medications may increase the risk of certain cancers, specifically skin cancer and non-Hodgkin’s lymphoma.

To date, there has been no direct link between these cancers and the topical use of these medications. The finding is based on animal studies and a few reports of these cancers in patients treated with a calcineurin inhibitor. The animal studies indicate that the risk of these cancers increases when the amount of medication given by injection, not applied to the skin, increases.

While there have been reports of these cancers in a few patients treated with pimecrolimus or tacrolimus, the incidence in patients using this topical medication does not exceed the number of cancers expected in the population at large. Given the data, the American Academy of Dermatology disagrees with the FDA’s addition of a black box warning.

The Academy believes that the data does not prove that proper topical use of pimecrolimus and tacrolimus is dangerous,” says dermatologist Clay J. Cockerell, M.D., 2005 president of the American Academy of Dermatology. “Because these medications are applied to the skin, virtually none of it gets inside the body. It’s not the same as taking a pill. These are valuable medications, and if used properly, they allow millions of our patients with eczema to live normal lives.”

Tacrolimus received FDA approval for the treatment of moderate to severe atopic dermatitis in December 2000. Pimecrolimus received approval in December 2001 for treating mild to moderate atopic dermatitis.
 

References:
American Academy of Dermatology. “American Academy of Dermatology Issues Statement In Response to FDA Decision Related to Two Eczema Medications
.” American Academy of Dermatology Web site. News release issued March 10, 2005.

American Academy of Dermatology. “American Academy of Dermatology Responds to FDA Decision on Eczema Medications.” American Academy of Dermatology Web site. News release issued January 19, 2006.

Bigby, M. “Tacrolimus and Pimecrolimus for Atopic Dermatitis: Where Do They Fit In?” Archives of Dermatology. 2006 September;142(9):1203-1205.


All content solely developed by the American Academy of Dermatology

The U.S. Food and Drug Administration (FDA) has approved 2 topical calcineurin inhibitors for the treatment of atopic dermatitis in patients who are at least 2 years of age:

  • Pimecrolimus cream

  • Tacrolimus ointment


 
 

 

 

 

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Page last updated 4/4/07

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