Frequently Asked Questions about ELIDEL
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You may also browse through some common questions about eczema:
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 people ages 2 and older who have mild to 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 find that other treatments aren't right 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 people ages 2 and older. Do not use Elidel cream on a child under 2 years old. Please see your doctor to find out if ELIDEL is right for you.
4. How much does ELIDEL cost?
It's best to check the 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 limit sun exposure during treatment, even when ELIDEL is not on your skin.
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:
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Hydrate dry skin with a lukewarm (not hot) soaking bath for approximately 10-20 minutes. |
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Use only soaps and moisturizers recommended by your doctor; avoid anything abrasive or with perfume. (Soap-free cleansers are best). |
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After bathing, pat the skin almost dry, and within 3 minutes apply moisturizing cream or ointment. |
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Try to avoid rapid changes of temperature or humidity. |
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If the eczema worsens with sweating, try to avoid activities that cause sweating. |
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In general, wear clothing made of cotton or soft fabrics—avoid rough, scratchy fabrics and tight clothing. |
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Try to identify and avoid any "trigger" that makes the eczema worse. |
Additional advice for children:
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Keep your child's fingernails short, to lessen scratching that can break the skin. |
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Dress your child in loose-fitting, 100% cotton clothing. This reduces sweating, which can be an irritant. |
10. Who should not use ELIDEL?
Do not use ELIDEL Cream:
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On children under 2 years of age. |
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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. |
11. What should I tell my doctor before starting ELIDEL Cream?
Before you start using ELIDEL Cream, tell your doctor about all of your medical conditions, including if you:
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Have a skin disease called Netherton's syndrome (a rare inherited condition) |
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Have any infection on your skin including chicken pox or herpes |
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Have been told you have a weakened immune system |
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Are pregnant, breastfeeding, or planning to become pregnant |
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.
Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.
12. 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.
13. 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.
14. 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.
15. Should ELIDEL be reapplied after bathing or swimming?
Everyone's situation is different. Please check with your doctor for their recommendation.
16. Is it important to be careful about going out in the sun, or using a tanning bed, while using ELIDEL?
Limit sun exposure during treatment, even when ELIDEL is not on your skin. Ask your doctor what other types of sun protection should be used.
17. 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.
18. If sunscreen needs to be reapplied, should ELIDEL also be reapplied?
No—unless it's time for the next application of ELIDEL.
19. 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 makeup.
20. If makeup needs to be reapplied, should ELIDEL be reapplied, too?
No—unless it's time for the next application of ELIDEL.
21. What does the boxed warning in the ELIDEL label say? What are the other changes to the label for ELIDEL?
The boxed warning, which is located in the Warning section of the product label, states:
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g. skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream.
Therefore:
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Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
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ELIDEL Cream is not indicated for use in people less than 2 years of age. |
Changes were also made to other sections of the label, including the wording of the indication section as well as the addition of a Warning's section.
22. What is a boxed (or "black box") warning?
A boxed warning is included in a product label. It is used when the FDA believes there is a need to highlight a significant safety concern.
23. What does the medication guide for ELIDEL say?
The medication guide is based on the updated label and includes important information you should know about ELIDEL, how you should use ELIDEL, what you should avoid when using ELIDEL, and more.
Click here to view the entire medication guide for ELIDEL.
24. What is a medication guide?
A medication guide is issued by the FDA and includes patient information for prescription drugs when the FDA believes they pose a serious and significant public health concern.
25. Why did the FDA require a label change?
The FDA changed the label in January 2006 due to concerns over a specific class of drugs that treat eczema, called topical calcineurin inhibitors, including ELIDEL.
The FDA's concern for these types of drugs was based on a theoretical risk which stemmed from events that have been seen with high doses in animal studies and transplant patients. The adverse events were associated with prolonged systemic immunosuppression.
This effect cannot be achieved with ELIDEL Cream because it is applied to the skin and very low amounts enter the blood stream. In fact, in clinical studies most blood levels of ELIDEL were too low to measure.
26. What does systemic immunosuppression mean?
Systemic immunosuppression is a disorder or condition when the immune system is not able to perform its routine function. The immune system helps protect the body from diseases and infections, for example identifying and attacking foreign antigens. Systemic immunosuppression can be the result of many different causes or factors (such as genetic conditions, and some disease states or treatments).
27. Is there any evidence linking ELIDEL Cream to the cause of malignancy or lymphoma?
There is no evidence of a cause and effect relationship between the use of ELIDEL Cream and malignancy or lymphoma. This is acknowledged in the FDA revised label.
28. Is ELIDEL Cream safe for the use in children?
Yes. ELIDEL Cream is approved by the FDA for people ages 2 and older.
29. How can I learn more about this issue?
For more information about eczema please visit:
National Eczema Association
www.nationaleczema.org
The National Eczema Association (NEA) works to improve the health and the quality of life of persons living with atopic dermatitis/eczema, including those who have the disease as well as their loved ones.
Inflammatory Skin Disease Institute
www.isdionline.org
The goal of the Inflammatory Skin Disease Institute (ISDI) is to promote public awareness and enhanced treatment of inflammatory skin diseases through education, research, and patient advocacy.
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