What is Elidel Cream?

• Elidel Cream is used to treat mild to moderate atopic dermatitis, a form of eczema. It should be used only for a short time. It is not for continuous long-term use.
   
• Elidel Cream should not be the first prescription treatment that you try to treat your atopic dermatitis. Use Elidel Cream only after other prescription treatments did not work or if other prescription treatments are not right for you.  
   
• Elidel Cream is approved for adults and children 2 years and older with normal immune systems.

Who Should Not Use Elidel Cream?

Do not use if:

• Your child with atopic dermatitis is younger than 2 years
• You have been told you have an immune system problem
• You have any infection on your skin including chicken pox or herpes
• You have Netherton’s Syndrome. This is a rare inherited condition where the skin is red, itchy, and covered with large coarse scales.
• You are pregnant or breastfeeding, unless directed by your doctor.
• You are allergic to Elidel Cream or any of its ingredients

What are The Risks?

The following are the major potential risks and side effects of Elidel Cream therapy. However, this list is not complete.

• Possible risk of cancer: As noted in the  Elidel Cream label and patient Medication Guide, although a link has not been made, rare cases of cancer (for example, skin and lymphoma) have been reported in patients who use Elidel Cream. The manufacturer is conducting studies to examine the risk of cancer. These studies may take many years to complete.
   
• Viral infections: Elidel Cream may increase the chance of getting chicken pox, shingles, skin warts, or other viral infections.
   
• Skin irritation: Elidel Cream’s most common side effect is a sensation of warmth or burning where you apply the cream. See your doctor if your reaction is severe, or you have it for more than 1 week.
   
• Other side effects may include headache, throat or nose redness and soreness, flu symptoms, fever, and cough.

What Should I Tell My Healthcare Professional?

Before you start using Elidel Cream, tell your healthcare professional if:

• You are getting light therapy for your skin (phototherapy, UVA or UVB) or a lot of sun exposure
• You are taking any prescription or nonprescription (over-the-counter) medicine or supplements
• You are using any other skin product

After you start using Elidel Cream, tell your healthcare professional if:

• Your atopic dermatitis does not get better after 6 weeks of use
• Your atopic dermatitis gets worse
• You get an infection on your skin

How Do I Use Elidel Cream?

• Wash your hands before using Elidel Cream.
• Make sure your skin is dry before applying Elidel Cream.
• Put a thin layer of Elidel Cream on the affected skin twice a day, unless otherwise directed by your doctor. Rub in completely. Use the minimum amount of Elidel Cream necessary and apply only to the affected skin areas.
• Wash your hands after applying Elidel Cream unless you are treating your hands.
• Do not use Elidel Cream under a bandage or wrap that keeps out air.
• Stop using Elidel Cream once your symptoms go away.
• Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Elidel Cream, even while Elidel Cream is not on your skin.

FDA ALERT [3/2005]:

The FDA has issued a public health advisory to inform healthcare professionals and patients about a potential cancer risk from use of Elidel (pimecrolimus).  This concern is based on information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work.  It may take human studies of ten years or longer to determine if use of Elidel is linked to cancer.  In the meantime, this risk is uncertain, and FDA advises Elidel should be used only as labeled, for patients after other prescription treatments have failed to work or cannot be tolerated.

Recommendations

Physicians with patients using Elidel, or who are considering prescribing the drug, should consider the following:

• Use Elidel only as second-line agent for short-term and intermittent treatment of atopic dermatitis, a form of eczema, in patients unresponsive to, or intolerant of other treatments.

• Avoid use of Elidel in children younger than 2 years of age. The effect of Elidel on the developing immune system in infants and children is not known. In clinical studies, infants and children younger than 2 years old treated with Elidel had a higher rate of upper respiratory infections than those treated with placebo cream.

• Use Elidel only for short periods of time, not continuously. The long term safety of Elidel is unknown.

• Children and adults with a weakened or compromised immune system should not use Elidel.

• Use the minimum amount of Elidel needed to control the patient’s symptoms. In animals, increasing the dose resulted in higher rates of cancer.

Data Summary

Although pimecrolimus is not genotoxic and does not interact directly with DNA, it may have a potential to impair local immunosurveillance. Repeat dose studies conducted with topical application of pimecrolimus in mice demonstrated a dose and treatment dependent development of lymphoma. Carcinogenicity studies conducted with oral administration of pimecrolimus in mice demonstrated a dose dependent development of lymphoma and benign thymoma. Carcinogenicity studies conducted with topical administration of pimecrolimus in rats demonstrated development of follicular cell adenoma of the thyroid. Data from a recently conducted oral nine-month monkey study showed a dose-related increase in virus-associated lymphoma following administration of pimecrolimus.

As of December 2004, the FDA had received 10 cases of postmarketing reports linking Elidel with cancer-related adverse events. Four cases occurred in children, 3 of these in children less than 6 years of age. The other 6 cases occurred in adults.

Of the 10 postmarketing cases reporting cancer, 6 described cutaneous tumors, 1 described a lymph node/cutaneous tumor related event, and the locations of 3 others were unreported. Four cases described lymphomas; 5 cases described a variety of tumors, including basal cell carcinoma and squamous cell carcinoma; and 1 case described granulomatous lymphadenitis. The median time until diagnosis after initiation of treatment with Elidel was 90 days, with a range between 1 week and 300 days. Two cases also reported a lymphadenopathy. Two cases were confounded, 1 with the presence of nodules prior to the diagnosis of basal cell carcinoma; and another with a pre-existing condition associated with an increased risk for malignant transformation.

Elidel is sometimes absorbed through the skin, though usually at very low amounts. Occasionally, children who have been treated with Elidel have had measurable blood levels of the drug. The potential for systemic immunosuppression is unknown and the role of Elidel in the development of the cancer-related events in the individual postmarketing cases is also uncertain.

Date created: February 14, 2005, updated June 15, 2006