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.

Elidel FDA Approved 2001
Patient Information Sheet Revised 3/2005, 5/2006

Date created: February 14, 2005, updated May, 2006