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Pimecrolimus

Elidel

Elidel (pimecrolimus) cream, 1%, is an innovative topical treatment for mild to moderate eczema in adults and children over two years old. FDA-approved, it works by modulating the immune system to reduce inflammation and alleviate symptoms of atopic dermatitis. Applied twice daily, Elidel effectively controls eczema flare-ups. While generally safe, it can have side effects like skin irritation or increased risk of infections. 

Elidel Overview

Elidel (pimecrolimus) cream, 1%, is a topical immunomodulating medication mainly used to treat mild to moderate atopic dermatitis (eczema) in adults & children aged two years and older. This FDA-approved treatment targets the underlying immune processes contributing to eczema, a chronic skin condition characterized by inflammation and itching. Pimecrolimus, the active ingredient, selectively inhibits the production of inflammatory cytokines in the skin by blocking the activity of calcineurin, a key enzyme in the immune response. This action helps manage eczema symptoms without the typical side effects associated with steroids.

Elidel is available in a 1% cream formulation and is applied twice daily to the affected area. It is suitable for adults and children over the age of two. A thin layer of this cream should be used and fully absorbed into the skin to reduce inflammation and effectively relieve eczema symptoms. While Elidel is not a cure for eczema, it helps control flare-ups and maintain symptom-free periods when used as directed.

Users should be aware of the side effects, including skin reactions like burning, stinging, or itching at the application site. Severe side effects may include the risk of skin infections, lymphoma, and other cancers. It’s essential to follow precise application guidelines to avoid these risks. Apply Elidel as soon as remembered for missed doses unless it’s close to the time for the next dose. In case of an Elidel overdose, seek immediate medical attention. Elidel should be stored at room temperature and kept from moisture and heat. You must consult a certified medical expert for tailored advice and ensure proper use, especially in individuals with a compromised immune system or other immunosuppressive medications.

Uses of Elidel 

  • Eczema (mild to moderate) for adults and children aged 2 years and older.

Elidel Dosage

This medication comes as a cream with a strength of 1%.

Recommended Dosage of Elidel for Different Patients

Adult Dosage for Atopic Dermatitis:

  • Gently spread a fine layer of the cream on the affected area twice daily, rubbing it in gently and thoroughly.

Pediatric Dosage for Atopic Dermatitis (Ages 2 years and older):

  • Evenly apply a minimal layer of the medication on the affected area twice daily, making sure to rub it gently and completely.

[Note: Remember that these recommendations can differ for each individual. Consult your doctor to tailor the dosage specifically for you.]

How to Take Elidel?

  • Apply a thin layer of Elidel cream or ointment to the affected skin areas twice a day, once in the morning and once in the evening.
  • Wash your hands before applying Elidel unless you are treating the hands themselves.
  • Softly massage the medication into the skin until it is completely absorbed.
  • Avoid applying Elidel to areas of skin that are infected, have viral lesions, or have wounds.
  • Do not apply Elidel to the eyes, lips, or mucous membranes.
  • After applying Elidel, do not cover the treated areas with occlusive dressings or wrappings.
  • If you are using other topical medications, apply them at times different than Elidel or wait until Elidel has been fully absorbed before applying the other medicines.
  • Do not take Elidel orally or use it more significantly or more often than your doctor prescribes.
  • Elidel is for external use only and should not be used for prolonged periods without consulting your medical expert.

[Note: Your doctor will determine the appropriate dosage for you based on your specific condition and the established guidelines and research on the medication. They will make adjustments as necessary over time.]

How Does Elidel Work?

Elidel is a topical medication used to treat inflammation associated with eczema, specifically targeting mild to moderate forms. It falls under the category of calcineurin inhibitors. The mechanism involves blocking the activity of calcineurin, an enzyme crucial for activating T-cells, a type of white blood cell involved in inflammatory responses. By inhibiting this enzyme, Elidel effectively reduces the production of inflammatory cytokines, thereby decreasing the immune system’s response, which leads to skin inflammation and symptoms of eczema. This targeted approach helps manage the itching and redness without the typical side effects of steroids.

Elidel Side Effects

Common side effects of this medication include:

  • Skin burning or stinging sensation
  • Redness or irritation of the skin
  • Itching
  • Skin warmth or flushing
  • Acne
  • Headache
  • Viral skin infections (e.g., cold sores, shingles)
  • Cough
  • Fever
  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Flu-like symptoms

Serious Side Effects of Elidel Medication Include:

  • Skin infections
    • Elidel suppresses the immune system and can increase the risk of bacterial, viral, or fungal skin infections, including herpes simplex infections.
    • Signs of infection may encompass fever, pus or oozing from the skin, and worsening redness/swelling.
  • Lymphoma and other cancers
    • Long-term use of Elidel may potentially increase the risk of lymphoma and other cancers, especially in immunocompromised patients.
    • Any new skin lesions or lumps should be evaluated.
  • Allergic reactions
    • Severe allergic reactions like anaphylaxis, though rare, can occur with Elidel use.
    • Symptoms may comprise difficulty breathing, swelling of the face/throat, and severe dizziness.
  • Cushing’s syndrome
    • Long-term, widespread use of Elidel can potentially lead to Cushing’s syndrome due to systemic absorption.
    • Signs include weight gain, rounding of the face, and increased body hair growth.
  • Effects on immune response
    • Elidel can suppress the immune system, potentially increasing the risk of infections or worsening existing infections.
    • Live vaccinations should be avoided during treatment.
  • Photosensitivity
    • Elidel may cause increased sunlight and UV light sensitivity, leading to severe sunburns.
    • Sun protection measures are recommended.
  • Eye exposure
    • Accidental exposure of Elidel to the eyes can cause severe eye irritation and vision changes.

[Note: This list does not include all potential side effects. Always seek suggestions from your healthcare provider for guidance on side effects.]

Elidel Warnings

  • Long-Term Use and Cancer Risk:
      • Elidel (pimecrolimus) carries a rare risk of causing skin and lymphoma cancers.
      • Use Elidel as directed and not beyond the duration prescribed by your healthcare provider.
      • Apply only to affected areas, avoiding healthy skin.
      • If symptoms persist beyond 6 weeks, consult your healthcare provider.
      • Before treating new eczema-like areas with Elidel, confirm with your provider that these are not pre-cancerous or cancer-related growths.
  • Risk Warning for Young Children:
      • Do not use Elidel on children younger than 2 years old.
      • Consider this medication for children only if no other treatments are effective and under medical advice.
  • Infection Risk:
      • Elidel can increase the risk of viral and bacterial infections (such as chickenpox and shingles).
      • Avoid applying Elidel on active infections. If an infection develops while using Elidel, discontinue use and contact your healthcare provider.
  • Swollen Lymph Nodes:
      • Elidel may cause swollen lymph nodes.
      • Regular checks for swollen lymph nodes are recommended; testing may be required to determine the cause.
      • You may need to stop using Elidel, depending on the cause of the swelling.
  • Avoid Sun Exposure:
      • Elidel can increase sun sensitivity.
      • Use sunscreen and wear protective clothing when outdoors. Avoid tanning beds and direct sunlight exposure.
  • Caution for People with Weakened Immune Systems:
    • Individuals with compromised immune systems, for instance, those with advanced HIV, organ transplant recipients, cancer patients, or those on immunosuppressive drugs, should not use Elidel.
    • Elidel’s immune system suppression can lead to severe infections and other side effects.

Elidel Boxed Warning 

Elidel carries a boxed warning, the FDA’s most serious caution, alerting doctors and patients to potentially dangerous drug effects.

  • Elidel’s long-term safety is not fully established. There are rare reports of cancers, such as skin cancer and lymphoma, following the use of topical calcineurin inhibitors like Elidel.
  • It is unclear whether Elidel or other factors directly cause these cancers.
  • Due to potential risks, using Elidel for periods exceeding one year is generally not recommended. Application should be limited to areas affected by eczema.
  • Elidel is not approved for use in children under the age of 2.

Elidel Precautions

  • Netherton syndrome: Elidel is contraindicated in patients with Netherton syndrome. This rare genetic condition causes increased skin absorption, as it can lead to higher systemic exposure and an increased risk of side effects.
  • Skin infections: Elidel should not be used on skin areas affected by viral infections like herpes simplex, chickenpox, or shingles, as it may worsen or spread the infection. It should also be avoided in areas with active bacterial or fungal skin infections unless adequately treated first.
  • Immunocompromised patients: Elidel should be used with caution in individuals with weak immune systems, like those with HIV/AIDS or those receiving immunosuppressive medications, as it may increase the risk of infections due to its immunomodulatory effects.
  • Allergic reactions: Elidel is contraindicated in patients with known hypersensitivity or allergic reactions to pimecrolimus or any inactive ingredients in the formulation.
  • Pregnancy: Elidel’s safety during pregnancy has not been established. Before prescribing Elidel to pregnant women, healthcare providers should consider the potential benefits and risks.
  • Breastfeeding: Elidel is not advised during breastfeeding because it is unclear if the medication passes into human milk and how it might impact a nursing baby.

Elidel Contraindications

  • Hypersensitivity or allergic reactions: Elidel should be avoided in those with a known hypersensitivity or allergic reaction to pimecrolimus or any inactive ingredients in the formulation.
  • Malignant or pre-malignant skin conditions: Elidel is contraindicated in patients with skin cancer or pre-cancerous skin lesions, as it may potentially increase the risk of malignancy.
  • Erythrodermic, Gilbert’s syndrome, or immunodeficient skin diseases: Elidel is not recommended for use in patients with these conditions due to the potential for increased systemic absorption and adverse effects.
  • Vaccination with live vaccines: Elidel may interfere with the efficacy of live vaccines, so it should not be used in patients who have recently received or are expected to receive one.

Elidel Missed Dose

If you forget to apply a dose of Elidel, apply it as soon as you remember. However, if it’s close to your next scheduled dose, simply leave the missed dose and proceed with your regular application schedule. Do not apply extra cream to compensate for the missed dose. Consider using a medication reminder to ensure you don’t miss a dose. This could be an alarm, a note in a visible location like your bathroom mirror or bedside table, or a reminder app on your smartphone.

[Note: If you miss a medication dose and are uncertain when to take the next one, consult your doctor or pharmacist immediately.]

Elidel Overdose 

An overdose of Elidel (pimecrolimus) cream should be addressed promptly due to potential increased side effects. If someone has applied too much Elidel or ingested it, contact poison control or immediately seek emergency medical attention. Overdose symptoms may comprise severe skin irritation or systemic effects due to excessive immune suppression. It’s essential to use Elidel only as directed by a healthcare provider.

[Note: If you have taken more than the recommended dose, seek immediate medical assistance or contact the Poison Help line at 1-800-222-1222.]

Elidel Storage

  • Store at an average temperature between 68°F and 77°F.
  • Keep Elidel tightly closed in its original container to protect it from moisture and light.
  • Do not store Elidel in the bathroom or near a sink, as the moisture and heat can cause the medication to degrade.
  • Keep Elidel and all medications out of the reach of children and pets.
  • Do not use Elidel after the expiration date printed on the tube or bottle.
  • Once opened, Elidel cream should be used within six weeks, and Elidel ointment should be used within 12 weeks.
  • Discard any unused portion after the recommended use period (6 weeks for cream and 12 weeks for ointment).
  • Do not store Elidel in extreme temperatures, for instance, in a car during hot or cold weather.
  • If you notice any changes in Elidel’s appearance, color, or texture, do not use it; consult your pharmacist or healthcare provider.

[Note: Consult your healthcare professional about the correct way to dispose of unused medicine and for any questions related to its storage.]

Elidel Interactions

  • Immunosuppressive agents: Concomitant use of Elidel with systemic immunosuppressive agents, like cyclosporine, tacrolimus, or corticosteroids, may increase the risk of skin infections and other adverse effects due to additive immunosuppressive effects.
  • Antifungal agents: Certain antifungal medications, like ketoconazole and itraconazole, may increase the systemic absorption of Elidel by inhibiting its metabolism. This could spike the risk of adverse effects.
  • Vaccinations: Live vaccinations should be avoided during treatment with Elidel, as the medication may suppress the immune response and reduce the vaccine’s effectiveness.
  • Phototherapy: Concurrent use of Elidel with phototherapy (e.g., UVB or PUVA) may increase the risk of skin cancer or lymphoma. Caution should be exercised when using these treatments together.
  • Other topical medications: Elidel should not be used concurrently with other topical medications, such as corticosteroids or calcineurin inhibitors, on the same skin area, as it may increase the risk of adverse effects or alter the absorption and efficacy of the medications.

[Note: This list is not exhaustive, and other drugs may also interact with Elidel. Be sure to inform your doctor about all prescription, over-the-counter medications and herbal products you are using.]

Elidel Alternatives

[Note: Your doctor will determine the best treatment for you. Do not use any of these alternative medications without consulting your healthcare provider, as self-medication could lead to serious side effects.]

Frequently Asked Questions For Elidel

Is Elidel a steroid?

Elidel is not a steroid. It is part of a group of medications known as calcineurin inhibitors, which inhibit a protein responsible for activating the immune system. This suppression helps reduce the inflammation associated with eczema. While steroids also mitigate inflammation by calming the immune system, they operate through a different mechanism and belong to a separate class of medications.

Is it safe to use Elidel on the face?

Elidel cream can be safely applied in a thin layer to the face, avoiding contact with the eyes, nose, or mouth. It is important to use this medication as your healthcare provider prescribes, typically only for short durations.

Is Elidel available over the counter?

Elidel is not sold as an over-the-counter (OTC) medication. It is available only by prescription from your doctor and can be obtained at pharmacies. If you are seeking OTC treatments for eczema, it is recommended to consult with your doctor or pharmacist for appropriate guidance and options.

Is Elidel used to treat hyperpigmentation, acne, or vitiligo?

Elidel is not officially approved for treating hyperpigmentation, acne, or vitiligo. However, based on recommendations from the American Academy of Family Physicians, it may be used off-label to treat vitiligo in some instances. Off-label use involves prescribing a medication for conditions not among the approved indications. While Elidel is not recommended for treating hyperpigmentation or acne, it is important to note that these conditions have been reported as side effects of the medication.

Is Elidel classified as an immunosuppressant?

Yes, Elidel functions as an immunosuppressant by reducing the activity of the immune system. This suppression can elevate the risk of infections, particularly at the application site. Therefore, Elidel is not recommended for individuals with weak immune systems, like those with advanced HIV or those undergoing treatment with certain medications for cancer, organ transplants, or autoimmune diseases.

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