Elidel

What is the most important information I should know about Elidel?

• The FDA has issued a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel when applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel should be used only as labeled, for patients who have failed treatment with other therapies.
• Avoid sunlight and sun lamps, tanning beds, and treatments with UVA or UVB light. If you need to be outdoors after applying Elidel, wear loose clothing that protects the treated area from the sun. Also, ask your doctor what other type of protection from the sun may be needed.
• Even though your skin will begin to look and feel better, it is important to keep using Elidel as instructed by your doctor. Elidel should be used for as long as the symptoms of atopic dermatitis persist or as directed by your doctor.
• Talk to your doctor if the condition does not improve or if it gets worse during the first few weeks of treatment.
• Unless otherwise instructed by your doctor, do not apply any other skin products on the areas treated with Elidel.

What is Elidel?

• Elidel is an immunosuppressant. Immunosuppressants decrease the effects of the body's immune system.
• Elidel is used to treat atopic dermatitis (e.g., eczema).
• Elidel may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using Elidel?

• The FDA has issued a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel when applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel should be used only as labeled, for patients who have failed treatment with other therapies.
• Do not use Elidel without first talking to your doctor if you have the congenital skin disorder Netherton's syndrome.
• Before using Elidel, tell your doctor if you:
  · are taking oral or injectable tacrolimus (Prograf), cyclosporine (Neoral, Sandimmune), mycophenolate mofetil (CellCept), azathioprine (Imuran), sirolimus (Rapamune), or another immunosuppressant medication;
  · have a skin infection;
  · have a disease of the immune system; or
  · are using any other type of skin product (e.g., cream, ointment, lotion, etc.).
• You may not be able to use Elidel, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.
• Elidel is in the FDA pregnancy category C. This means that it is not known whether Elidel will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or are planning to become pregnant during treatment.
• It is not known whether Elidel passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
• Elidel is not approved for use by children younger than 2 years of age.

How should I use Elidel?

• Apply Elidel exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.
• Apply Elidel twice a day, about 12 hours apart, unless otherwise directed by your doctor.
• Wash your hands before and after each application, unless you are using Elidel to treat a hand condition.
• Before applying Elidel after a shower or bath, be sure the skin is completely dry.
• Apply a thin layer of Elidel to all skin areas that your doctor has diagnosed as having atopic dermatitis (e.g., eczema). Rub the medication gently and completely into the skin.
• Do not cover the area being treated with bandages, dressings, or wraps. However, normal clothing can be worn over the treated areas.
• Unless otherwise instructed by your doctor, do not apply any other skin products on the areas treated with Elidel.
• Do not bathe, shower or swim right after applying Elidel. This could wash off the medication.
• Use Elidel on the skin. Do not swallow this medication.
• Even though your skin will begin to look and feel better, it is important to keep using Elidel as instructed by your doctor. Elidel should be used for as long as the symptoms of atopic dermatitis persist or as directed by your doctor.
• Talk to your doctor if the condition does not improve or if it gets worse during the first few weeks of treatment.
• Store Elidel at room temperature away from moisture and heat.

What happens if I miss a dose?

• Use the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed, and use only the next regularly scheduled dose.

What happens if I overdose?

• If Elidel is ingested, seek emergency medical attention.
• Symptoms of a Elidel overdose are not known.

What should I avoid while using Elidel?

• Avoid sunlight and sun lamps, tanning beds, and treatments with UVA or UVB light. If you need to be outdoors after applying Elidel, wear loose clothing that protects the treated area from the sun. Also, ask your doctor what other type of protection from the sun may be needed.
• Do not cover the area being treated with bandages, dressings, or wraps. However, normal clothing can be worn over the treated areas.

What are the possible side effects of Elidel?

• If you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), stop using Elidel and seek emergency medical attention.
• It is not unusual to experience skin burning, stinging, itching, or soreness at the site of application of the medication. These side effects are most common during the first few days of treatment and typically improve as the lesions of atopic dermatitis heal.
• Other, less serious side effects may be more likely to occur. Continue to use Elidel and talk to your doctor if you experience:
  · irritation of nose and throat;
  · cough;
  · headache;
  · diarrhea, constipation, or upset stomach; or
  · skin infection.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Elidel?

• Unless otherwise instructed by your doctor, do not apply any other skin products on the areas treated with Elidel.
• Talk to your doctor before taking another medicine that may affect the immune system such as oral or injectable tacrolimus (Prograf), cyclosporine (Neoral, Sandimmune), mycophenolate mofetil (CellCept), azathioprine (Imuran), sirolimus (Rapamune), or another immunosuppressant medication. You may not be able to use Elidel, or you may require a dosage adjustment or special monitoring if you are taking another medicine that affects the immune system.
• Although unlikely, other systemic medications (taken by mouth or injection) may interact with Elidel. Talk to your doctor before taking any of the following medicines during treatment with Elidel:
  · an antifungal medicine such as ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan);
  · a calcium channel blocker (heart medicine) such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene);
  · erythromycin (Ery-Tab, E-Mycin, E.E.S., others), clarithromycin (Biaxin), or troleandomycin (TAO); or
  · cimetidine (Tagamet, Tagamet HB).
• Drugs other than those listed here may also interact with Elidel. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

• Your pharmacist has additional information about Elidel written for health professionals that you may read.