What to Know About Elidel and Protopic

Despite being effective, an FDA warning raises concerns

In This Article

Elidel (pimecrolimus) and Protopic (tacrolimus) are topical drugs used for the short-term treatment of eczema (atopic dermatitis). The drugs, classified topical calcineurin inhibitors (TCIs), are the first non-steroid topical medications developed to treat eczema.

Unlike topical steroids, TCIs can be used on the face and eyelids and are not associated with skin injury or the loss of drug action with repeated use. Side effects tend to be mild and may include mild itching and burning sensations.

Despite these benefits, Elidel and Protopic have their limitations and risks. Chief among them is a possible link to certain skin and blood cancers, a concern that prompted the U.S. Food and Drug Administration (FDA) to issue a black box warning in 2006.

Uses

Elidel and Protopic are the only topical calcineurin inhibitors currently approved by the FDA. Elidel is recommended for the treatment of mild to moderate atopic dermatitis, while Protopic is labeled for moderate to severe atopic dermatitis.

Topical calcineurin inhibitors work by blocking calcineurin, a naturally occurring compound that helps activate the immune system and stimulate pro-inflammatory cytokines. By "switching off" this response, the inflammation that drives eczema can be significantly relieved.

Elidel and Protopic are also often prescribed to treat other inflammatory skin conditions, such as psoriasis, seborrheic dermatitis, cutaneous lupus erythematosus, oral lichen planus, and vitiligo.

Because of their cost, doctors will sometimes reserve Elidel and Protopic for use on thinner/smaller areas of skin (such as the face or hands) and use cheaper topical steroids for larger areas of thicker skin (such as the arms, legs, and trunk).

Elidel and Protopic have certain benefits that set them apart from topical steroids:

  • They can be used repeatedly with no loss of drug action.
  • They can be used in children as young as 2.
  • They do not cause skin atrophy (thinning), striae (stretch marks), telangiectasia (spider veins), or skin discoloration.
  • They can be safely used on the face, neck, groin, around the eyes, or in skin folds.

Before Taking

Elidel and Protopic are recommended for the second-line treatment of eczema when topical steroids and other conservative therapies fail to provide relief. They are reserved for use in adults and children 2 years of age and over.

Precautions and Considerations

Because Elidel and Protopic work by tempering the immune response, they should not be used in anyone with a compromised immune system. Doing so may lead to further suppression of the immune response and an increased risk of opportunistic infections.

This includes people with advanced HIV infection, as well as organ transplant recipients and individuals undergoing cancer therapy (both of whom take immunosuppressant drugs).

Elidel and Protopic should also not be used in persons with a known hypersensitivity to pimecrolimus, tacrolimus, or any ingredient in the topical formulation. Because these effects are cross-reactive—meaning that hypersensitivity to one drug translates to hypersensitivity to both—you would need to avoid these and any other calcineurin inhibitors, including cyclosporine and oral or injectable Prograf (tacrolimus).

Dosage

Elidel is available in a topical cream and contains 1% pimecrolimus. Protopic is available as a topical ointment with either 0.03% or 0.1% tacrolimus. The choice of drug is based on the severity of your symptoms as diagnosed by a qualified dermatologist.

How to Take and Store

Elidel and Protopic are applied twice daily to the skin in a thin layer. The drugs should not be used as a moisturizer, even in severe cases. If symptoms do not improve after six weeks of use, treatment options should be reviewed. Applying Elidel or Protopic more frequently will not improve results.

Elidel and Protopic can be safely stored at room temperature (77 degrees F). Short-term exposure to temperatures ranging from 59 degrees F to 86 degrees F will not compromise the drugs' efficacy, but you should avoid storing the drugs in hot places (e.g., your glove compartment) or in direct sunlight. Never use a drug after its expiration date.

Elidel and Protopic are intended for short-term use or the intermittent treatment of chronic eczema. They are not intended for continuous, long-term use.

Side Effects

As with all drugs, Elidel and Protopic may cause side effects. Most are relatively mild and tend to resolve once the body adapts to treatment.

Common

The most common side effect is a burning or itching sensation, which is experienced by approximately 25% of users. A headache, cough, nasal congestion, sore throat, upset stomach, and muscle aches have also been noted.

Elidel is associated with an increased risk of certain infections, including folliculitis, pneumonia, impetigo, sinusitis, otitis media, and influenza. Between 3% and 8% of users may be affected.

Skin reactions are more common with Protopic, including urticaria (hives), erythema (redness), and bacterial skin infections. Oral antihistamines and topical antibiotics can often provide relief.

Severe

Although the risk of anaphylaxis (a severe, whole-body allergy) is considered low, Protopic has been known to cause the reactivation of the chickenpox virus in some people, leading to an outbreak of shingles.

Others may experience a vesiculobullous rash, characterized by the formation of tiny, chickenpox-like blisters on the application site.

When to See a Doctor

Rashes of any sort should be seen by a doctor. If they are accompanied by shortness of breath, rapid heartbeat, dizziness, or the swelling of the face, tongue, or throat, call 911. These may the signs of an anaphylactic emergency.

Warnings

Elidel and Protopic are classified at Pregnancy Category C drugs, meaning that adequate studies in humans are lacking but the potential benefits of treatment may outweigh the risks. Animal research has shown a slight increase in the risk of birth defects when the drugs are given at doses far beyond what would be used in humans.

Due to the lack of safety research, speak with your doctor about the potential benefits and risks of Elidel or Protopic if you are pregnant or breastfeeding (or intend to be).

Black Box Warning

In 2006, the FDA issued a black box warning advising consumers and healthcare professionals the Elidel and Protopic were linked to an increased risk of skin cancer and lymphoma (in particular, T-cell lymphoma).

While recognizing that the incidence of cancer was "rare," the FDA decided that the advisement was warranted given the over-prescribing of the drug among infants and toddlers as well as the drugs' off-label use in treating a variety of other rashes.

It was a controversial decision that continues to be criticized by both the American Academy of Dermatology (AAD) and the American Academy of Allergy, Asthma, and Immunology (AAAAI).

Research submitted to the FDA in 2013 found no evidence of an increased risk of lymphoma among 625,915 people who used Protopic or Elidel for an average of five and a half years.

With respect to skin cancer, the FDA based its conclusions on studies involving organ recipients exposed to intravenous tacrolimus or cyclosporine. Although these users did experience an increased risk of skin cancer and lymphoma, no such increase has ever been seen in users of topical tacrolimus or pimecrolimus.

According to research published at the time of the FDA warning, the risk of lymphoma or skin cancer among the 11 million users of Protopic or Elidel has never been greater than that of the general population.

Interactions

It remains unclear if Elidel or Protopic can interact with other medications. Although little research has been done to investigate potential interactions, both drugs are known to utilize an enzyme known as cytochrome P450 3A4 (CYP3A4) for metabolization.

As such, it may be possible for Elidel or Protopic to interact with drugs that inhibit CYP3A4, resulting in an abnormal build-up of Elidel and Protopic in the body. These include:

  • Calcium channel blockers
  • Diflucan (fluconazole)
  • Erythromycin
  • Nizoral (ketoconazole)
  • Sporanox (itraconazole)
  • Tagamet (cimetidine)

While it is unclear how significant the interactions may be (if at all), it is important to advise your doctor of any drug you may be taking whether it is prescription, over-the-counter, nutritional, or recreational.

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Article Sources
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