Elidel

Elidel is a prescription medication used to treat eczema in adults and children at least 2 years of age. Elidel is in a class of drugs called topical calcineurin inhibitors. It works by reducing inflammation, which helps relieve symptoms of eczema.

Elidel is a prescription medication used to treat a skin condition called eczema (atopic dermatitis) in adults and children 2 years and older who do not have a weakened immune system. Elidel is for use after other prescription medicines have not worked, or if other prescription medicines can not be used.

• Valeant Pharmaceuticals North America LLC

Elidel may cause serious side effects. A very small number of people who have used Elidel have gotten cancer (for example, skin cancer or lymphoma). But, a link that Elidel caused these cancers has not been shown.

The most common side effect at the skin application site is burning or a feeling of warmth. These side effects are usually mild or moderate, happen during the first few days of treatment, and usually clear up in a few days. Call your doctor if the burning feeling is severe or lasts for more than 1 week.

Other side effects include headache, common cold or stuffy nose, sore throat, influenza, fever, viral infection, and cough. Some people may get viral skin infections (like cold sores, chicken pox, shingles, or warts) or swollen lymph nodes (glands).

Tell your doctor if you have a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.

These are not all the possible side effects with Elidel. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you receive:

• antifungal medications
• calcium channel blockers
• cimetidine (Tagamet)
• clarithromycin (Biaxin)
• cyclosporine (Neoral, Sandimmune)
• danazol (Danocrine)
• delavirdine (Rescriptor)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• fluoxetine (Prozac, Sarafem)
• fluvoxamine (Luvox)
• HIV protease inhibitors
• isoniazid (INH, Nydrazid)
• metronidazole (Flagyl)
• nefazodone
• oral contraceptives (birth control pills)
• other ointments, creams, or lotions
• troleandomycin (TAO)
• zafirlukast (Accolate)

This is not a complete list of Elidel drug interactions. For more information, ask your doctor or pharmacist.

It is not known if Elidel is safe to use for a long period of time. A very small number of people who have used Elidel have gotten cancer (for example, skin cancer or lymphoma). But a link that Elidel use caused these cancers has not been shown. Because of this concern:

• Do not use Elidel continuously - for a long time.
• Use only on areas of your skin that have eczema.
• Do not use this medication on a child under 2 years old.

Do not use Elidel if you are allergic to anything in it.

Grapefruit and grapefruit juice may interact with Elidel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you start using Elidel, tell your doctor about all of your medical conditions, including if you:

• have a skin disease called Netherton’s syndrome (a rare inherited condition)
• have any infection on your skin including chicken pox or herpes
• have been told you have a weakened immune system 
• 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 if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Elidel falls into category C. In animal studies, Elidel did not cause any problems when it was applied topically on the skin of pregnant animals. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Elidel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Elidel.

Use Elidel exactly as prescribed. 

• Use Elidel only on areas of your skin that have eczema. 
• Use Elidel for short periods, and if needed, treatment may be repeated with breaks in between.
• Stop Elidel when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
• Follow your doctor’s advice if symptoms of eczema return after a treatment with Elidel.
• Call your doctor if:
  • your symptoms get worse with Elidel 
  • you get an infection on your skin
  • your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

To apply this medication:

Read and carefully follow the directions below.

• Wash your hands before using Elidel. If you apply Elidel after a bath or shower, make sure your skin is dry.
• Apply a thin layer of Elidel only to the affected skin areas, two times each day, as directed by your doctor.
• Use the smallest amount of Elidel needed to control the signs and symptoms of eczema.
• If you apply Elidel to another person, or if you have eczema and are not treating your hands, it is important for you to wash your hands with soap and water after applying Elidel. This should remove any cream left on your hands.
• Do not bathe, shower or swim right after applying Elidel. This could wash off the cream.
• You can use moisturizers with Elidel. Make sure you check with your doctor first about the products that are right for you. People with eczema can have very dry skin, so it is important to keep up good skin care practices. If you use moisturizers, apply them after this medication.

What to avoid while using Elidel:

• You should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with Elidel.
• Limit your time in the sun during treatment with Elidel even when the medicine is not on your skin. If you need to be outdoors after applying Elidel, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use. It is not known how Elidel may affect your skin with exposure to ultraviolet light.
• Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
• Elidel is for use on the skin only. Do not get this medication in your eyes, nose, mouth, vagina, or rectum (mucous membranes). If you get it in any of these areas, burning or irritation can happen. Wipe off any medication from the affected area and then rinse the area well with cold water.
• Do not swallow Elidel. If you do, call your doctor.
• Avoid using Elidel on skin areas that have cancers or pre-cancers.

Use Elidel exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Elidel is usually applied in a thin layer to the affected skin twice daily.

If you use too much Elidel, contact your local Poison Control Center or seek emergency medical attention right away.

• Store Elidel at room temperature between 59° to 86°F (15° to 30°C).
• Keep Elidel and all medicines out of the reach of children.

WARNING

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.

Therefore:

• Continuous long-term use of topical calcineurin inhibitors, including Elidel, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
• Elidel is not indicated for use in children less than 2 years of age.