Calcineurin Inhibitors

Topical calcineurin inhibitors (TCIs) are a class of medications used to treat atopic dermatitis, eczema and other skin conditions.

Calcineurin inhibitors, also called "immunomodulators", help to regulate the immune system and block the inflammation associated with eczema.

Calcineurin inhibitors are often prescribed as an alternative to topical corticosteroids or when other treatments have failed or lead to unwanted side effects. Unlike topical corticosteroids, topical calcineurin inhibitors do not thin the skin and can be applied to sensitive areas, such as the face and eyelids, where corticosteroids are avoided.

Calcineurin inhibitors are generally prescribed for the short-term treatment of people age 2 and older with a healthy immune system. Short-term treatments may be repeated.

Calcineurin inhibitors may be combined with other eczema treatments and should be used along with proper skin care, such as the regular use of a moisturizer.

There presently two FDA approved calcineurin inhibitors prescribed in the U.S.

  • Pimecrolimus (Elidel®)
  • Tacrolimus (Protopic®)

Both formulations have been shown to be effective for use in atopic dermatitis when applied twice a day to affected skin. Most people using these medication report a reduction in itching within 3 days of starting treatment.

Side Effects of Calcineurin Inhibitors

Most side effects from these medication are been mild and temporary. The more severe the eczema, the more likely the patient is to experience these side effects. A common side effect of topical calcineurin inhibitors is a burning and itching that goes away after the first few days of treatment. The burning sensation is usually limited to the area being treated.

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

  • Avoid exposure to sunlight, tanning beds, sun lamps, and treatment with ultraviolet (UV) light while taking these medications. Sun protection is essential.
  • Tell your doctor if you are pregnant or breast-feeding.

Rare cases of cancer have been reported in people using pimecrolimus and tacrolimus. In 2006, the FDA added a black box warning to topical pimecrolimus and topical tacrolimus. 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 calcineurin inhibitors. The finding is based on animal studies that 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 medication on the skindoes not exceed the average number of cancers expected in the population. Given the data, the American Academy of Dermatology disagrees with the FDA’s addition of a black box warning.

In 2005, the President of the Academy stated that "the data does not prove that proper topical use of pimecrolimus and tacrolimus is dangerous. 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.”

Talk to your doctor about the benefits and risks of using a calcineurin inhibitor.

Use the medication exactly as directed by your doctor. Do not take more or less of it or take it more often than prescribed by your doctor.

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Last updated: 6/27/2020