WARNING

Elidel (pimecrolimus) is a topical medication used to treat eczema (atopic dermatitis) in patients who cannot use other treatments or have not responded to them. While generally considered safe and effective when used as directed, like any medication, Elidel comes with potential risks. Here are some of them:

• Skin Irritation: Elidel may cause mild and temporary irritation at the application site, such as burning or itching.
• Increased Risk of Skin Infections: Since Elidel suppresses the immune system locally, there is a slightly increased risk of developing skin infections such as cold sores or herpes simplex.
• Lymphoma and Skin Cancer: There have been concerns about a possible association between Elidel use and an increased risk of lymphoma and skin cancer, particularly when used long-term or in high doses. However, studies on this matter have yielded conflicting results, and the FDA has not confirmed a definitive link.
• Systemic Effects: While Elidel is a topical medication, there’s a possibility that some of it can be absorbed into the bloodstream, especially if applied to broken skin or in large amounts. This could potentially lead to systemic effects, although they are rare.
• FDA Black Box Warning: The FDA has issued a black box warning for Elidel due to concerns about a possible link to skin cancer and lymphoma. This is the most serious warning issued by the FDA and indicates that there may be significant risks associated with the medication.

It’s essential for patients to discuss these risks with their healthcare provider before starting Elidel treatment, especially if they have a history of skin cancer, immune system disorders, or other medical conditions. Additionally, patients should follow their healthcare provider’s instructions carefully and report any unusual symptoms or side effects while using Elidel.

Why is this medication prescribed?

Elidel (pimecrolimus) is prescribed primarily for the treatment of eczema, specifically atopic dermatitis, in patients who cannot use or have not responded to other treatments. Eczema is a chronic inflammatory skin condition characterized by red, itchy, and dry skin patches. Elidel works by inhibiting the activation of certain immune cells involved in the inflammatory response, thus reducing inflammation and symptoms associated with eczema.

How should this medicine be used?

Here’s how Elidel should be used:

• Wash and dry hands and affected skin: Before applying Elidel, wash your hands and the affected skin with mild soap and water. Gently pat the skin dry.
• Apply a thin layer: Use a pea-sized amount of Elidel and apply it thinly and evenly to the affected areas of the skin. Rub it in gently until it disappears.
• Avoid contact with eyes, mouth, and mucous membranes: Be careful to avoid getting Elidel in your eyes, mouth, or other mucous membranes. If accidental contact occurs, rinse thoroughly with water.
• Use as directed: Follow your healthcare provider’s instructions regarding the frequency and duration of Elidel use. Typically, it’s applied twice daily to affected areas.
• Do not cover treated areas: After applying Elidel, do not cover the treated areas with bandages, dressings, or occlusive clothing unless instructed otherwise by your healthcare provider.
• Continue treatment as directed: Even if symptoms improve, continue using Elidel as directed by your healthcare provider. Stopping treatment abruptly can lead to a recurrence of symptoms.
• Avoid sunlight and UV light: While using Elidel, minimize exposure to sunlight and UV light, as this medication can increase sensitivity to sunlight. Wear protective clothing and use sunscreen if you need to be outdoors.
• Report any side effects: If you experience any unusual symptoms or side effects while using Elidel, such as severe irritation or skin infections, contact your healthcare provider promptly.

It’s essential to follow these instructions carefully and discuss any questions or concerns with your healthcare provider before starting treatment with Elidel.

Other uses for this medicine

While Elidel is primarily indicated for the treatment of eczema, there have been off-label uses reported for conditions such as psoriasis and seborrheic dermatitis. However, it’s important to note that these uses are not officially approved, and you should always consult with a healthcare professional before using Elidel for any condition other than eczema.

What special precautions should I follow?

Regarding special precautions for using Elidel, here are some important points to consider:

• Avoid exposure to sunlight and UV light: Elidel can increase sensitivity to sunlight, so it’s important to minimize exposure to sunlight and UV light while using this medication. Wear protective clothing and use sunscreen when outdoors.
• Avoid contact with eyes, mouth, and mucous membranes: Be careful to avoid getting Elidel in your eyes, mouth, or other mucous membranes. If accidental contact occurs, rinse thoroughly with water.
• Use caution in certain populations: Elidel should be used with caution in individuals with a weakened immune system, as well as in pregnant or breastfeeding women. Discuss the risks and benefits of using Elidel with your healthcare provider if you fall into any of these categories.
• Report any side effects: If you experience any unusual symptoms or side effects while using Elidel, such as severe irritation or skin infections, contact your healthcare provider promptly.
• Follow your healthcare provider’s instructions: Always use Elidel exactly as prescribed by your healthcare provider. Do not use more or less of it or use it more often than prescribed.

By following these precautions and guidelines, you can help ensure safe and effective use of Elidel for the treatment of your condition.

What special dietary instructions should I follow?

There are typically no specific dietary instructions associated with Elidel use. However, maintaining a healthy diet rich in fruits, vegetables, whole grains, and lean proteins can support overall skin health and may complement the treatment of eczema.

What should I do if I forget a dose?

If you forget to apply a dose of Elidel, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply extra medication to make up for a missed dose.

What side effects can this medication cause?

Elidel (pimecrolimus) is generally considered safe and well-tolerated when used as directed. However, like any medication, it can cause side effects in some individuals. Common side effects of Elidel may include:

• Mild and Temporary Skin Irritation: This can manifest as burning, itching, redness, or stinging at the application site. These symptoms typically improve as your skin adjusts to the medication.
• Increased Sensitivity to Sunlight: Elidel can make your skin more sensitive to sunlight and UV light. This may result in sunburn more easily, so it’s important to use sunscreen and protective clothing when outdoors.
• Headache: Some individuals may experience headaches while using Elidel. If headaches persist or become severe, consult your healthcare provider.
• Cold-like Symptoms: This can include symptoms such as a runny or stuffy nose, sneezing, or sore throat.
• Application Site Reactions: In some cases, individuals may experience skin reactions such as folliculitis (inflammation of hair follicles) or acne.
• Burning Sensation in the Eye: If Elidel accidentally gets into the eyes, it may cause a temporary burning sensation. Rinse thoroughly with water if this occurs.

It’s important to note that serious side effects with Elidel are rare. However, there have been concerns about a potential increased risk of skin cancer and lymphoma associated with its use. The FDA has issued a black box warning regarding this potential risk, although studies on this matter have yielded conflicting results.

If you experience any unusual or severe side effects while using Elidel, such as severe skin irritation, signs of skin infection, or any other concerning symptoms, contact your healthcare provider promptly.

As always, discuss any questions or concerns about potential side effects with your healthcare provider before starting treatment with Elidel. They can provide personalized guidance based on your medical history and individual risk factors.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Store Elidel at room temperature, away from moisture and heat. Keep the tube tightly closed when not in use.
• Keep Out of Reach of Children: Store Elidel out of reach of children and pets to prevent accidental ingestion.
• Disposal: Dispose of unused or expired Elidel medication properly according to local regulations or as directed by your healthcare provider or pharmacist. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.

In case of emergency/overdose

In case of an emergency or suspected overdose of Elidel, contact your local poison control center (1-800-222-1222 in the United States) or seek emergency medical attention immediately. Overdose symptoms may include severe skin irritation, burning, or itching.

What other information should I know?

• Follow-up Appointments: Attend all follow-up appointments with your healthcare provider to monitor your response to Elidel treatment and discuss any concerns or side effects.
• Avoid Other Topical Medications: Avoid using other topical medications on the same areas of skin being treated with Elidel unless directed by your healthcare provider.
• Avoid Abrupt Discontinuation: Do not stop using Elidel abruptly without consulting your healthcare provider, as doing so may cause a recurrence of symptoms.
• Avoid Contact with Eyes, Mouth, and Mucous Membranes: Be careful to avoid getting Elidel in your eyes, mouth, or other mucous membranes. If accidental contact occurs, rinse thoroughly with water.
• Report Any Adverse Effects: Report any unusual or severe side effects to your healthcare provider promptly.
• Pregnancy and Breastfeeding: Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before using Elidel. Discuss the potential risks and benefits with your healthcare provider.
• Regular Skin Examinations: Because of concerns about skin cancer and lymphoma, your healthcare provider may recommend regular skin examinations while using Elidel, especially if you have a history of skin cancer or lymphoma.

Always follow your healthcare provider’s instructions and guidance regarding the use of Elidel, and consult them with any questions or concerns you may have.