1.   What exactly is the eczema medicine, ELIDEL?
2. How is ELIDEL used?
3. Can ELIDEL be used on people of any age?
4. How much does ELIDEL cost?
5. Do I need to see my doctor to get ELIDEL?
6. Are there any side effects?
7. Will other people be able to tell when my child or I use ELIDEL? Does it smell or stain clothes?
8. What should I do if I (or my child) miss a dose?
9. While using ELIDEL, what else can be done to help care for the skin?
10. Who should not use ELIDEL?
11. How should ELIDEL be stored?
12. Which should I apply to the skin first-moisturizers or ELIDEL?
13. Will ELIDEL wash off if one bathes or swims right after applying it?
14. Should ELIDEL be reapplied after bathing or swimming?
15. Is it important to be careful about going out in the sun, or using a tanning bed, while using ELIDEL?
16. Is it okay to use sunscreen with ELIDEL? If so, which should be applied first?
17. If sunscreen needs to be re-applied, should ELIDEL also be reapplied?
18. Can makeup be used while using ELIDEL? And if so, should makeup be put on before or after applying ELIDEL?
19. If make-up needs to be reapplied, should ELIDEL be reapplied, too?
20. What is the recent FDA health advisory about?
21. What actions have been taken?
22. How Can I Learn More About This Issue?

 

1. What exactly is the eczema medicine, ELIDEL?
ELIDEL (pimecrolimus) Cream 1% is a steroid-free prescription cream that controls the itching and redness of eczema. It is for many patients-including children as young as 2-who have mild or moderate eczema. (This accounts for most of the people with eczema.)

Many people with eczema are also treated with an assortment of medications. However, when you and your doctor are concerned about the risks of other eczema treatments, you or your child’s ability to tolerate them, or they don’t work for you or your child, your doctor may prescribe ELIDEL. Once prescribed, steroid-free ELIDEL can be used anywhere on your skin, including your face, neck, and around the eyes.

2. How is ELIDEL used?
ELIDEL is for use on the skin only, and only to treat eczema that has been diagnosed by a doctor. ELIDEL can be used on any skin surface, even on the most delicate skin areas such as the face and neck and around the eyes. Apply a thin layer of ELIDEL twice a day to control the itching and redness of eczema. ELIDEL stays mostly on the skin where it’s applied, and you can start and stop using ELIDEL repeatedly as directed by your doctor.

3. Can ELIDEL be used on people of any age?
ELIDEL may be used on children as young as 2 years, all the way up to adults. Please see your doctor to find out if ELIDEL is right for you.

4. How much does ELIDEL cost?
It’s best to check price with your pharmacy of choice, as prices do vary.

5. Do I need to see my doctor to get ELIDEL?
Yes, ELIDEL is available by prescription only.

6. Are there any side effects?
ELIDEL was well tolerated in clinical studies. The most common side effects were a feeling of warmth or burning where the cream was applied, which was mild and went away within a few days; headache, cold-like symptoms such as stuffy nose, sore throat, and cough, and, rarely, viral skin infection. When using ELIDEL, you should avoid unprotected exposure to the sun or sun lamps.

7. Will other people be able to tell when my child or I use ELIDEL? Does it smell or stain clothes?
Unlike most ointments, not only is ELIDEL cream non-greasy, it has no odor. Because it’s non-greasy and absorbs quickly, it shouldn’t stain clothes or sheets.

8. What should I do if I (or my child) miss a dose?
Although you should apply ELIDEL as prescribed, missing a dose sporadically shouldn’t affect your treatment. Use ELIDEL according to the directions on the prescription, or as directed by your doctor.

9. While using ELIDEL, what else can be done to help care for the skin?
Experts advise these steps to help soothe and heal the skin:

• Hydrate dry skin with a lukewarm (not hot) soaking bath for approximately 10-20 minutes
• Use only soaps and moisturizers recommended by your doctor; avoid anything abrasive or with perfume. (soap-free cleansers are best)
• After bathing, pat the skin almost dry, and within 3 minutes apply moisturizing cream or ointment
• Try to avoid rapid changes of temperature or humidity
• If the eczema worsens with sweating, try to avoid activities that cause sweating
• In general, wear clothing made of cotton or soft fabrics-avoid rough, scratchy fabrics and tight clothing
• Try to identify and avoid any “trigger” that makes the eczema worse

Additional advice for children:

• Keep your child’s fingernails short, to lessen scratching that can break the skin
• Dress your child in loose-fitting, 100% cotton clothing. This reduces sweating, which can be an irritant

10. Who should not use ELIDEL?

• If you are pregnant or a nursing mother, you should use ELIDEL only if your doctor determines that it is clearly necessary. It is not known if the medicine in ELIDEL will pass through your milk to the baby.
• If you have a skin condition called Netherton’s syndrome, ask your doctor before you start using ELIDEL.
• If you are allergic to ELIDEL or any of its ingredients. The active ingredient is pimecrolimus. If you need to know the inactive ingredients, ask your doctor or pharmacist.
• If you think you have a viral infection of your skin, like chicken pox or herpes, do not apply ELIDEL on these areas. Check with your doctor about what to do.

Before you start using ELIDEL, tell your doctor if you are:

• Using any other prescription medicines, non-prescription (over-the-counter) medicines, supplements or herbal medicines. Some medicines should be used carefully if you use ELIDEL.
• Receiving any form of light therapy (phototherapy, UVA or UVB) on your skin.
• Using any other type of skin product.
• Pregnant or planning to become pregnant. ELIDEL may not be right for you.

11. How should ELIDEL be stored?
Store ELIDEL at room temperature, between 59-86 degrees Fahrenheit. Do not freeze. Never leave ELIDEL in your car in cold or hot weather. Make sure the cap on the tube is tightly closed. Keep ELIDEL out of the reach of children.

12. Which should I apply to the skin first-moisturizers or ELIDEL?
Any moisturizers you use should be put on after ELIDEL is applied and fully absorbed. Be sure to discuss with your doctor the good skin care practices that will help keep the skin healthy and moisturized.

13. Will ELIDEL wash off if one bathes or swims right after applying it?
It’s important that you don’t bathe, shower or swim right after applying ELIDEL, because the cream could wash off.

14. Should ELIDEL be reapplied after bathing or swimming?
Everyone’s situation is different. Please check with your doctor for their recommendation.

15. Is it important to be careful about going out in the sun, or using a tanning bed, while using ELIDEL?
When using ELIDEL, avoid unprotected exposure to the sun or tanning lamps. Ask your doctor what other types of sun protection should be used.

16. Is it okay to use sunscreen with ELIDEL? If so, which should be applied first?
It’s recommended that you apply the ELIDEL first. After it’s fully absorbed into the skin, then you can apply sunscreen.

17. If sunscreen needs to be re-applied, should ELIDEL also be reapplied?
No- unless it’s time for the next application of ELIDEL.

18. Can makeup be used while using ELIDEL? And if so, should makeup be put on before or after applying ELIDEL?
Yes. Apply the ELIDEL first. After it’s fully absorbed into the skin, then apply make-up.

19. If make-up needs to be reapplied, should ELIDEL be reapplied, too?
No- unless it’s time for the next application of ELIDEL.

20. What is the recent FDA health advisory about?
As for all products, the FDA monitors adverse event reports that occur while the drug is on the market. The purpose of the February 15th Advisory Committee meeting was to “discuss risk evaluation, product labeling, what risk to communicate, and how to communicate information on potential cancer risk among pediatric patients treated for atopic dermatitis” with drugs in this class (Elidel and Protopic®). No cause and effect link between Elidel and this risk has been established.

21. What actions have been taken?
The Pediatric Advisory committee recommended to the FDA that a “black box” warning , about an unknown cancer risk based on data from animal studies, be added to both Elidel’s and Protopic’s product labeling. A black box warning is a strict tool the FDA can use to convey a potential significant safety signal or risk. On March 10th the FDA issued a Public Health Advisory about this. No cause and effect link between Elidel and this risk has been established.

22. How Can I Learn More About This Issue?
For more information regarding this issue please visit the following website:
NEASE (National Eczema Association for Science and Education)