Elidel Cream

The active ingredient in Elidel Cream is pimecrolimus. It works by inhibiting the activity of calcineurin, an enzyme involved in activating T-cells in the immune system. By blocking calcineurin, Elidel reduces the release of substances that cause inflammation, redness, and itching in the skin.

Follow all directions given to you by your doctor and read all documents provided, including the complete Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Elidel Cream. However, the following is a synopsis of the general guidelines for the use of Elidel Cream:

• Wash and dry your hands and the affected area of your skin gently before application.
• Apply a thin layer of cream to the affected skin areas twice daily (morning and evening) or as directed by your doctor.
• Only use this medicine on the affected areas of your skin, and use the smallest amount needed to manage your symptoms. Avoid applying it to your eyes, mouth, genitals, or rectum, as this can cause burning and irritation. If the medication accidentally gets on those areas, wipe off as much as possible and rinse thoroughly with cold water.
• Rub in gently and completely, avoiding use on infected or broken skin.
• Wash hands after applying unless treating your hands.
• Do not cover treated areas with bandages, dressings, or occlusive wraps unless instructed by your doctor.
• Minimize exposure of treated skin to sunlight and UV sun lamps. Use sunscreen and wear protective clothing to lower your risk of sun damage.
• Use for short-term treatment during flare-ups or as directed for intermittent long-term use; discontinue once symptoms resolve.
• Contact your doctor if symptoms worsen or do not improve after several weeks.

The most common side effects of Elidel Cream include:

• Stinging or burning sensation at the application site.
• Redness, itching, or skin irritation.
• Increased sensitivity to sunlight in treated areas.
• Headache.
• Upper respiratory symptoms, such as cough or a sore throat.

Some individuals may experience serious side effects while using Elidel Cream. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of infections, especially viral infections (e.g., chickenpox, cold sores, shingles, or herpes) or fungal skin infections.
• Signs of an allergic reaction, such as rash, hives, severe itching, swelling (especially of the face, tongue, or throat), or difficulty breathing.
• Rare reports of lymphoma or skin cancer associated with long-term use of calcineurin inhibitors like pimecrolimus, although the link is not confirmed.

These are not all of the possible side effects of Elidel Cream. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Elidel Cream, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Do not use Elidel cream on infected skin, open wounds, or areas with active bacterial, viral, or fungal infections.
• Avoid use if you have a weakened immune system (e.g., due to HIV, organ transplant, or certain medications).
• Minimize exposure of treated skin to sunlight, tanning beds, or UV lamps, as the cream may increase sensitivity to UV rays.
• Elidel is not approved for use in children under 2 years old.
• Avoid long-term continuous use; only apply during flare-ups or as directed by your doctor.
• Inform your doctor if you have a history of skin cancer or pre-cancerous skin conditions or if you have a skin disease called Netherton’s syndrome (a rare inherited condition).
• Stop use and consult a doctor if symptoms worsen or persist or if signs of infection appear (e.g., redness, swelling, pus).
• Do not use with occlusive dressings unless advised by your healthcare provider.
• Avoid contact with eyes, mouth, or mucous membranes; rinse thoroughly with water if accidental contact occurs.

Boxed Warning

Rare cases of skin cancer and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Elidel Cream, although a definitive link has not been established. Because of this possible risk, the continuous long-term use of Elidel Cream should be avoided, and it should only be used on affected areas of the skin. It should also not be used in children less than 2 years of age.

You should not use Elidel Cream if any of the following conditions apply:

• Hypersensitivity.
• Weakened immune system or if you have Netherton’s syndrome.
• Children under 2 years of age.

Elidel cream typically begins to show improvement in eczema symptoms within 1 week of use. However, the full benefits may take several weeks to be seen, depending on the severity of the condition and individual response.

When Elidel Cream is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other immune-suppressing drugs: Using Elidel in combination with systemic immunosuppressive medications (e.g., corticosteroids, tacrolimus, or other calcineurin inhibitors) may increase the risk of immune suppression or infections.
• Topical treatments: When using other topical treatments, particularly those with corticosteroids or strong immunosuppressive agents, it is important to consult your healthcare provider to avoid potential interactions or additive effects.

Elidel cream (pimecrolimus) is available in a 1% strength for topical use. This is the only concentration currently available for treating mild to moderate eczema (atopic dermatitis). It is applied as a thin layer to affected areas of the skin, typically twice daily, as directed by a healthcare provider.

To store Elidel cream, keep it at room temperature (between 68°F to 77°F or 20°C to 25°C). Avoid freezing the cream or exposing it to excessive heat. Store the cream in its original tube and make sure the cap is tightly closed when not in use. Keep it out of the reach of children and pets.

Elidel cream is manufactured by Sanofi, a global healthcare company.

Yes, the generic version of Elidel cream is pimecrolimus cream.

Talk to your healthcare provider to stop taking Elidel Cream, as they can help you create a plan to stop safely.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.