What is Protopic?
Protopic is an ointment that contains the active substance tacrolimus (0.1% or 0.03%).
What is Protopic used for?
Protopic is used in the treatment of moderate to severe atopic dermatitis (eczema, or itchy redness of the skin). "Atopic" means that it is related to an allergy. Protopic is used in patients two years and older who do not respond adequately or who do not tolerate conventional therapies, such as locally applied corticosteroids.
Protopic can be used as an initial treatment of the disease and also as a "maintenance" therapy to prevent possible attacks of the disease or to extend the period without relapse. In maintenance therapy it is used in patients who usually have four or more attacks per year and who have responded to an initial cycle of Protopic given twice a day for up to six weeks.
The medicine can only be obtained with a prescription.
How is Protopic used?
Protopic should be prescribed by a doctor experienced in the diagnosis and treatment of atopic dermatitis. Protopic can be used for short-term treatment and intermittent long-term treatment, but should not be used continuously. The ointment must be applied to the skin in a thin layer.
In case of initial treatment, Protopic should be administered as soon as symptoms appear. All affected areas of the skin are treated with Protopic until the skin is healed. An improvement is generally observed within a week of starting treatment. If there is no improvement after two weeks, the doctor must move towards other types of treatment. For children, Protopic 0.03% should be used twice a day for up to three weeks, after which the frequency of applications should be reduced to once a day. In adults the treatment should start with Protopic 0.1% twice a day, but as soon as improvement occurs, it should be reduced by decreasing the frequency of applications or using the lowest dosage.
In the case of maintenance therapy, Protopic should be applied twice a week to areas of the skin usually affected by the disease. Children should use Protopic 0.03% and adults should use Protopic 0.1%. If signs of attack occur, treatment should be reported to the application twice a day. The doctor must assess whether it is necessary to continue the therapy of
maintenance after one year. In children this means suspension of treatment to allow the doctor to judge whether continued treatment is needed.
How does Protopic work?
The mechanism of action of Protopic in atopic dermatitis is still not entirely clear. The active substance in Protopic, tacrolimus, is an immunomodulator. This means that it acts on the immune system (the body's natural defenses). Tacrolimus has been used since the mid-1990s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ). In atopic dermatitis there is an overreaction of the skin's immune system, which causes skin inflammation (itching, redness and dryness). Tacrolimus reduces the activity of the immune system, thus helping to alleviate skin inflammation and itching.
How has Protopic been studied?
Initial treatment with Protopic has been studied in six main studies involving 1, 202 patients over the age of 16 and 1, 535 aged between 2 and 16 years. Protopic has been compared with placebo (a dummy treatment) or with hydrocortisone (a corticosteroid often used to treat eczema). The main measure of effectiveness was the improvement in eczema found at the end of the study after 3 or 12 weeks, using a scoring system that takes into account all the symptoms of atopic dermatitis. In another study, repeated use of Protopic was examined for up to four years in approximately 800 patients.
Protopic maintenance therapy was analyzed in two main studies involving 224 patients from the age of 16 and 250 from 2 to 15 years. All these patients had atopic dermatitis that had previously responded to a maximum of six weeks of treatment with Protopic. In these studies, Protopic was compared twice a week with placebo, but both groups of patients could use Protopic when they had a disease attack. The main measure of effectiveness was the number of attacks patients had had in a year.
What benefit has Protopic shown during the studies?
In the initial treatment of atopic dermatitis, Protopic was more effective than hydrocortisone in producing an improvement in symptoms, although it caused more burning than hydrocortisone. In the longer-lasting study, Protopic was used repeatedly without losing effectiveness.
In maintenance therapy, Protopic was more effective than placebo in reducing the number of attacks. In both studies, patients with moderate to severe disease who used Protopic had an average attack in one year, compared with three in a year for patients using placebo.
What is the risk associated with Protopic?
The most common side effects (seen in more than 1 patient in 10) are burning sensations and itching in the area of application. For the full list of all side effects reported with Protopic, see the Package Leaflet.
Protopic must not be used in people who are hypersensitive (allergic) to macrolides, tacrolimus or to any of the excipients.
Doctors need to know that a very small number of patients who used the medicine developed a tumor (skin cancer or lymphoma). A connection with Protopic has not been demonstrated. However, doctors must make sure that the medicine is used correctly.
Why has Protopic been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Protopic's benefits are greater than its risks in the treatment of moderate to severe atopic dermatitis and in maintenance therapy of moderate to severe atopic dermatitis for the prevention of attacks and the extension of the periods without attacks. The committee recommended that Protopic be given marketing authorization.
Further information on Protopic
On 28 February 2002 the European Commission issued a marketing authorization for Protopic, valid throughout the European Union. The marketing authorization was renewed on 28 February 2007. The authorization holder is Astellas Pharma Europe BV
The full EPAR for Protopic can be found here.
Last update of this summary: 04-2009.
