The French National Agency for the Safety of Medicines has authorized the use of tacrolimus 0.1% as a treatment option in France. It will be available through compassionate prescription for three years to both adults and children aged two years and older.
A new treatment for both adults and children over two years
A new framework called the Compassionate Prescription Framework (CPF), has been established for tacrolimus 0.1% in ointment form. This allows dermatologists to prescribe the product without violating the Marketing Authorization (MA) restrictions. However, to indicate that the prescription is beyond the MA, dermatologists must include the statement “Prescription for compassionate access outside the scope of the marketing authorization” on the prescription.
Indeed, for a drug to be prescribed for a disease, it must have received a prescription authorization: this is the famous “MA” (marketing authorization). Until now, tacrolimus 0.1% was only approved for atopic dermatitis and not for vitiligo. The CPC now officially allows the prescription of tacrolimus 0.1% ointment for vitiligo, without restriction.
The 0.1% ointment is used to treat vitiligo in adults and children above 2 years. Protopic® and Takrozem® are similar drugs that can be used for this purpose. Children can use this ointment to prevent depigmentation and repigment.
Whether the treatment is for adults or children, it must be followed for several months to determine whether it has positive effects or not. A 3-page therapeutic use protocol has been attached as an appendix to the CPC to provide information on the treatment modalities, application durations, and exposure to the sun or UV-B.
Information notes for patients
The prescribing physician is responsible for providing a detailed information note to the patient about the therapeutic use of tacrolimus for vitiligo. The note should contain specific instructions on the application methods, times, and precautions related to sun exposure and exposure to UV-B. It is essential to follow these instructions to ensure the effectiveness and safety of the treatment.
The note emphasizes the importance of being cautious when using tacrolimus for treating vitiligo in comparison to atopic dermatitis. Specifically, the note indicates that there is a positive correlation between natural UV or UV-B and the effectiveness of topical tacrolimus in treating vitiligo. Therefore, during treatment, it is recommended to have moderate but daily sun exposure.
