tacrolimus (Protopic)

Following a full submission

Tacrolimus 0.03% ointment (Protopic) is accepted for restricted use within NHS Scotland.

Licensed indication under review: for maintenance treatment of moderate to severe atopic dermatitis in children (aged 2 to15 years) for the prevention of flares and the prolongation of  flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

SMC Restriction: Use is restricted to initiation by doctors with a specialist interest and experience in treating atopic dermatitis using immunomodulatory therapy (this can include General Practitioners).

Twice weekly maintenance therapy with tacrolimus ointment resulted in reduced disease exacerbations when compared to intermittent use only to treat disease exacerbations.