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Protopic ointment (tacrolimus)


Protopic ointment (tacrolimus) is a new treatment for atopic dermatitis which has an effect similar to that of Class I and II steroids. Local irritation, especially in the form of burning and itching, is seen in about half of the patients treated. The active ingredient, tacrolimus, possesses systemic immunosuppressive potential, so Protopic should only be used for patients who do not respond satisfactorily to other relevant therapies. The cost of one gram of Protopic ointment is roughly ten times that of the same amount of steriod ointment. Protopic has not yet been designated a general reimbursement product, but individual reimbursement for the therapy may be granted. Protopic may only be prescribed by specialists in certain fields.



Protopic ointment is a new product for the treatment of atopic dermatitis, and it was marketed on 22 July 2002. The active ingredient, tacrolimus, is a known immunosupressant used in organ transplants. Tacrolimus exerts its anti-inflammatory effect by inhibiting the transcription – and thus the synthesis – of various cytokines.


Protopic ointment is indicated for the treatment of moderate to severe atopic dermatitis in adults and children over two years of age who have not responded satisfactorily to other therapies. Protopic may only be prescribed by specialists in dermatology, paediatrics or allergology.


The ointment is available in the strengths 0.1% and 0.03%. Only the weaker strength is recommended for use on children. Initially, the product is applied twice daily for three weeks, after which the dose may be reduced to one application daily until clearance of the lesion occurs. The ointment may not be used concomitantly with steroids or when the patient is also suffering from infected dermatitis. Clothing or sunscreen should be used to minimise exposure of the skin to sun or other forms of ultraviolet light while therapy is ongoing.



In Denmark, Class II and III steroids are recommended for the treatment of moderate to severe atopic dermatitis. In two published studies, however, tacrolimus was only compared with a Class I and II steroid respectively in children and adults.


Adults: Protopic was compared with hydrocortisone butyrate 0.1% in a study of 570 adult patients with moderate to severe atopic dermatitis. After three weeks, there was no difference in efficacy between tacrolimus 0.1% and hydrocortisone butyrate (63.5% versus 63.9%) measured as the median change in mEASI (modified Eczema Area and Severity Index). However, tacrolimus 0.03% displayed a significantly inferior efficacy (53.0%).


Children: Protopic was compared with hydrocortisone 1% in a study of 560 children aged 2-15 with moderate to severe atopic dermatitis. After three weeks, Protopic 0.03% and 0.1% displayed an efficacy – measured as in the above-mentioned study – that was significantly superior to that of hydrocortisone (55.2% and 60.2% versus 36.0%). There was also a significant difference in the efficacy of the two different strengths of Protopic.


Adverse drug reactions

Protopic does not cause skin atrophy, which is its advantage over steroids. In addition, Protopic can be used in sensitive areas such as the face and neck. On the other hand, the above-mentioned studies demonstrated a significantly higher incidence of local irritation in the form of a burning sensation, itching and redness (initially in about 50% of the adults and 20% of the children). However, this irritation resolved in most patients after 5-8 days of treatment (in roughly 20% of the adults and 5% of the children). There was no difference in adverse reactions to the two different strengths of Protopic. However, the extent to which a possible systemic absorption of tacrolimus affects the immune system, especially in children, has not yet been sufficiently studied. As a result, only Protopic 0.03% may be prescribed for children.


Drug interactions

Tacrolimus is metabolised in the liver via CYP3A4. Although there is little systemic absorption through the skin, the possibility of interactions with known CYP3A4 inhibitors (e.g. erythromycin, itaconazole and ketoconazole) cannot be ruled out. There is also the possibility that tacrolimus may weaken the efficacy of vaccinations, which is why Protopic therapy should be discontinued at least 14 days prior to a vaccination and resumed not earlier than 14 days after. Skin emollients should not be applied to the treatment area within two hours of applying Protopic ointment.


The cost of one gram of Protopic ointment is about ten times that of comparable therapies.


Product  Contents  Cost (DKK)  Price per gram (DKK)
Hydrocortisone 1% cream 30 ml  hydrocortisone (Class I)  72.80  2.43
Mildison Lipid 1% cream 30 g  hydrocortisone (Class I)  48.90  1.63
Locoid 0.1% ointment 30 g  hydrocortisone butyrate (Class II)  57.20  1.91
Protopic 0.03% ointment 30 g
Protopic 0.1% ointment 30 g 
tacrolimus  352.35
Uniderm 1% ointment 50 g  hydrocortisone (Class I)  60.05  1.20

For additional information, see the summary of product characteristics for Protopic.

Last modified: July 22th 2002

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