TAYSIDE DEPARTMENT OF DERMATOLOGY PROTOCOL FOR PRESCRIBING TOPICAL PIMECROLIMUS

LICENSED INDICATIONS

Topical pimecrolimus (Elidel cream 1%) is a lipophilic anti-inflammatory ascomycin macrolactam derivative and an inhibitor of production and release of pro- inflammatory cytokines. It is licensed for use in –

Mild to moderate atopic dermatitis in children over 2 years for short term treatment of signs and symptoms and long term intermittent treatment for prevention of progression to flares.

NATIONAL / LOCAL RECOMMENDATION

• The Scottish Medicines Consortium (SMC) recommends that pimecrolimus cream should not be used in NHS Scotland.

• The NICE (Technology Appraisal Guidance No 82, Aug 04) recommends that “Pimecrolimus is considered as an option for the second-line treatment of moderate atopic eczema on the face and neck in children aged 2 -16 years that has not been controlled by topical corticosteroids, where there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy”

• Pimecrolimus cream is categorised locally as “Recommended for use within specialist treatment pathway” (NMIP, Dec 04).

PATIENT CRITERIA

Conventional treatment with topical emollient / steroid regimens will remain for now the mainstay of treatment for most patients with atopic dermatitis (eczema). Use of topical pimecrolimus may however be considered as an alternative to systemic therapy (as is the case with phototherapy) in children (2 years of age and above) in the following situations –

• Facial/Neck eczema - Where continuous use of moderate strength topical steroid is required and there is a serious risk of skin atrophy. Pimecrolimus appears not to be associated with impaired collagen synthesis or thinning of the skin.

• Intolerance of Tacrolimus - Pimecrolimus may be tried as an alternative. NB Pimecrolimus cream is licensed in moderate but not severe atopic dermatitis.

Note: As there is a theoretical risk of skin malignancy with long term treatment of immunomodulators, NICE recommends careful discussion of potential risks and benefits with the patient.

PATIENT INSTRUCTIONS

Apply thinly to the affected areas of face and neck twice daily. The affected areas should be dry but emollients can be applied immediately afterwards. When clearance occurs then treatment should be discontinued but can be restarted if the rash recurs.

Pimecrolimus must not be used on mucous membranes.

Topical corticosteroids should not be used concurrently in those areas being treated with Pimecrolimus.

Patients should be advised to avoid UV exposure while using topical Pimecrolimus, use a sunblock to exposed skin on a regular basis and avoid using topical Pimecrolimus on summer holidays. Also avoid sunbeds whilst using topical Pimecrolimus Cream.

CONTRAINDICATIONS

Allergy to pimecrolimus or other excipients listed in Summary of Product Characteristics

Do not use when undergoing photo(chemo)therapy or for 2 months after

CAUTIONS / SIDE EFFECTS

Elidel should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chicken pox). Before commencing treatment with Elidel clinical infections at treatment site should be cleared

Vaccinations should be administered pre-treatment, or 14 days after treatment ceases However, interactions with systemically administered medication and vaccinations considered unlikely due to minimal absorption. Pimecrolimus is exclusively metabolised by CYP 3A4 and should therefore be used with caution in patients receiving drugs that inhibit CYP 3A4 enzyme (eg. Erythromycin, ketoconazole, diltiazem)

Use of Elidel may cause mild and transient reactions at the site of application; if reaction is severe treatment should be re-evaluated

Elidel should not be applied under occlusion, especially wet-wrap bandaging

Elidel should not be used in pregnant women. Breastfeeding women may use Elidel but should not apply Elidel to the breast in order to avoid unintentional oral uptake by the newborn

Avoid in genetic epidermal barrier defects, e.g. Netherton’s syndrome

PRESCRIBING

Until further guidance is issued, treatment should be initiated by a Dermatologist ie may be prescribed in General Practice on the recommendation of a Dermatologist.

(NB off-label treatment in severe atopic dermatitis should be supplied from hospital pharmacy via pre-prepared NHS Tayside forms)

Available in 30g, 60g and 100g tubes Cost is ten times that of topical steroid therapies (£59 for 100g)

MONITORING

Topical pimecrolimus can be used both for short-term and intermittent long-term treatment

On initiating treatment, arrangements should be made for early review to assess response to treatment

For those using intermittent long-term treatment, appropriate ongoing review is required by dermatologist or liaison nurse

November 2004 Review November 2005