ELIDEL CREAM 1% 30G

ELIDEL contains pimecrolimus, a macrolactam ascomycin derivative that inhibits the phosphatase activity of calcineurin in T-cells. This prevents dephosphorylation of the transcription factor NFAT, blocking the transcription of pro-inflammatory cytokines (IL-2, IL-4, IL-10, IFN-gamma) and reducing the inflammatory cascade responsible for atopic dermatitis (eczema).

ELIDEL 1% cream is used as a second-line treatment for mild-to-moderate atopic dermatitis in adults and children aged 2 years and above when: topical corticosteroids are not suitable, have failed, or carry unacceptable risk (e.g., sensitive skin areas — face, neck, skin folds, genitalia); or when continuous use of a topical corticosteroid carries concern for skin atrophy.

Unlike topical corticosteroids, pimecrolimus does not cause skin thinning (atrophy), telangiectasia, or skin striae. This makes it particularly valuable for chronic application on facial and intertriginous skin. It is also used proactively to prevent flares when applied to areas that frequently relapse.

ELIDEL cream is applied topically to the affected skin areas. Do not apply to unaffected skin.

Treatment of Active Flares

•       Apply a thin layer of ELIDEL cream to the affected areas twice daily (morning and evening).

•       Rub in gently and completely until absorbed.

•       Continue until symptoms (itch, redness, rash) have resolved.

Proactive Therapy (Maintenance)

•       For patients with frequently relapsing atopic dermatitis: apply twice weekly to areas that typically flare to prevent recurrence.

Application Areas

•       ELIDEL may be applied to all skin areas, including the face, neck, skin folds (axillae, groin), and genitalia — areas where topical corticosteroids carry a high risk of skin atrophy.

•       Avoid application to eyes and mucous membranes.

•       Wash hands after application (unless the hands are the treated area).

Emollient Use

Emollients (moisturisers) may be applied immediately before or after ELIDEL. Do not apply ELIDEL immediately after bathing — dry the skin first.

ELIDEL is not for ophthalmic (eye), oral, or intravaginal use.

Very Common Side Effects (greater than 1 in 10)

•       Application site reactions: burning sensation, stinging, or pruritus (itch) immediately after applying the cream — particularly at the start of treatment. This usually improves after the first few days as skin settles.

Common Side Effects

•       Application site warmth and erythema.

•       Skin infections at application sites: impetigo, folliculitis, herpes simplex virus (cold sore) activation.

•       Headache.

•       Influenza-like symptoms.

Important Safety Considerations

•       Eczema herpeticum (widespread painful blistering in herpes-infected eczema skin) — if this occurs, stop ELIDEL and seek urgent treatment.

•       Lymphadenopathy (swollen lymph nodes) — monitor; if persistent and unexplained, seek assessment.

Pimecrolimus does not cause skin thinning, stretch marks, or adrenal suppression — it has no corticosteroid-type side effects.

Malignancy Boxed Warning

Regulatory authorities (FDA, EMA) have issued a precautionary warning regarding a theoretical risk of lymphoma and skin cancer with topical calcineurin inhibitors, based on systemic immunosuppression data and rare post-marketing reports. However, no causal link has been established in extensive long-term studies. ELIDEL is a second-line treatment and should be used for the shortest duration necessary to control symptoms. Avoid use on malignant or potentially malignant skin lesions.

Sun Protection

ELIDEL may increase photosensitivity. Minimise sun exposure to treated areas and use sun protection (sunscreen, protective clothing) when outdoors. Avoid UV lamps and phototherapy (PUVA, UVB) at treated sites.

Skin Infections

Do not apply ELIDEL to infected skin. Herpes simplex virus can be reactivated at application sites, causing cold sores or eczema herpeticum. If a viral skin infection occurs, treat and allow resolution before reapplying.

Systemic Absorption

Systemic absorption of pimecrolimus through intact skin is very low. Absorption is higher through inflamed, broken skin. However, long-term use over large body surface areas, particularly in young children, should be approached with caution.

Pregnancy and Breastfeeding

There is limited data on pregnancy. Use only if clearly necessary. Do not apply to the breast areas when breastfeeding, as the infant may inadvertently ingest the cream.

Systemic drug interactions are unlikely given the low systemic absorption of topically applied pimecrolimus. However:

•       Immunosuppressive drugs (systemic corticosteroids, cyclosporine, azathioprine) — the theoretical combined immunosuppression may increase infection risk; discuss with prescriber.

•       CYP3A4 inhibitors (itraconazole, erythromycin, ketoconazole) — may increase systemic pimecrolimus exposure in the unlikely event of significant absorption; this is rarely clinically relevant with topical use.

•       Vaccines — avoid vaccination at ELIDEL-treated skin sites (reduced local immune response). There are no systemic concerns with standard vaccination schedules.

•       Store below 25 degrees Celsius. Do not freeze.

•       Keep the tube tightly closed.

•       Keep out of reach and sight of children.

•       Do not use after the expiry date printed on the tube.

•       Once opened, use within 12 months.

ELIDEL 1% cream is a prescription-only medicine (POM) in Kenya, regulated by the Pharmacy and Poisons Board (PPB). It is used across dermatology, paediatrics, and primary care settings.

In Kenya and many countries, it is recommended as a second-line treatment after an adequate trial of topical corticosteroids. It should not be dispensed as a first-line treatment for eczema in the absence of a valid prescription.

Positioning in Treatment Hierarchy

ELIDEL is a second-line topical treatment for atopic dermatitis. First-line is topical corticosteroids of appropriate potency (mild potency for face, moderate for body, high potency for palms/soles). ELIDEL is indicated when: corticosteroids are ineffective; the patient has steroid-phobia with non-adherence; corticosteroid side effects are significant (skin atrophy, striae, perioral dermatitis); areas requiring long-term application where corticosteroids are unsuitable (eyelids, facial folds).

Proactive Therapy

Applying ELIDEL twice weekly to previously affected areas, even when skin appears clear, has been shown to significantly reduce the frequency of flares. This proactive maintenance approach may reduce the need for acute treatments and improve long-term disease control. It is particularly useful in patients with a clear pattern of recurrent flares in the same locations.

Counselling on the Malignancy Warning

Reassure patients that while a regulatory precautionary warning exists, over two decades of post-marketing experience and multiple large epidemiological studies have not confirmed a causal link between topical pimecrolimus and cancer. The warning arises from theoretical concerns. The benefit-risk balance for appropriately selected patients remains favourable. Continue to monitor and review the need for ongoing therapy at each consultation.

Paediatric Use

Not licensed for children below 2 years. For ages 2–17 years, twice-daily application is appropriate. For adolescents and adults, consider the long-acting version (tacrolimus 0.1% ointment/Protopic) for more severe or refractory cases as it is more potent.

Why does my skin burn when I first apply ELIDEL?

A mild to moderate burning or stinging sensation when ELIDEL is applied to active eczema is very common and expected, especially at the start of treatment. This is because the inflamed, broken skin is more sensitive. The sensation usually improves significantly within a few days as the eczema begins to improve. If the burning is very severe or persists beyond one week, contact your doctor or pharmacist.

Can ELIDEL be used on the face and around the eyes?

Yes — ELIDEL cream is specifically valuable for use on the face, eyelids, neck, and other sensitive areas where topical corticosteroids are not recommended for long-term use because of the risk of skin thinning. Avoid direct contact with the eye itself (conjunctiva and cornea). It is safe to use around the eye area on intact skin.

Is there a risk of cancer from using ELIDEL?

A theoretical precautionary warning about a possible link between calcineurin inhibitors and certain cancers was issued by regulators over 20 years ago. However, extensive post-marketing surveillance and large long-term studies involving hundreds of thousands of patients have not established any causal link. ELIDEL remains an approved and recommended treatment for atopic dermatitis in appropriate patients. Your doctor can discuss the evidence with you in more detail if you have concerns.