ELIDEL CREAM MADE BY NOVARTIS
ELIDEL® Can Help
Many people with mild or moderate eczema (this represents the majority of people suffering from eczema) are treated with a variety of medications. But when you and your doctor find that other treatments aren’t right for you, your doctor may prescribe steroid-free ELIDEL® (pimecrolimus) Cream 1%.
ELIDEL contains no steroids and is shown to effectively treat people with mild or moderate eczema. You can use it for repeated courses as directed by your doctor. ELIDEL is safe for children as young as 2.
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.
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.
ELIDEL Cream is not indicated for use in children less than 2 years of age.
Changes were also made to other sections of the label, including the wording of the indication as well as the addition of a Warning’s section.
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.
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.
The entire medication guide for ELIDEL.
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.
Why did the FDA require a label change in January 2006?
The FDA changed the label 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.
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).
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.
Is ELIDEL Cream safe for the use in children?
Yes. ELIDEL Cream is approved by the FDA for use in people ages 2 and older.