Tacrolimus (topical)


Brand Name(s):Protopic

Indication:Moderate to severe atopic dermatitis



Review Date:Oct-23

Drug Safety Update
Oral tacrolimus products: reminder to prescribe and dispense by brand name only
Nov 2017
Risk of malignancies
Healthcare professionals are reminded that tacrolimus may be associated with a possible risk of malignancy. Benign as well as malignant neoplasms including Epstein-Barr virus-associated lymphoproliferative disorders and skin malignancies have been reported in association with oral (systemic) tacrolimus treatment.

Cases of malignancies, including lymphomas and skin cancers have also been reported in patients using topically applied tacrolimus since it was licensed in 1999. In addition, findings from epidemiological studies have suggested a possible increased risk of cutaneous T-cell lymphoma in patients treated with topical calcineurin inhibitors, including tacrolimus ointment.

Healthcare professionals must remember that Protopic should not be prescribed to patients younger than 2 years, and that the use of Protopic in children aged 2 to 16 years is restricted to the lower strength 0.03% ointment only.

In addition, Protopic should not be applied to lesions that are considered to be potentially malignant or pre-malignant, or used in patients with congenital or acquired immunodeficiencies, or in patients on therapy that causes immunosuppression.

MHRA Guidance June 2012

Topical tacrolimus and pimecrolimus are not recommended for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity.

Topical tacrolimus is recommended, within its licensed indications, as an option for the second-line treatment of moderate to severe atopic eczema in adults and children aged 2 years and older that has not been controlled by topical corticosteroids (see Section 1.4), where there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy.

For the purposes of this guidance, atopic eczema that has not been controlled by topical corticosteroids refers to disease that has not shown a satisfactory clinical response to adequate use of the maximum strength and potency that is appropriate for the patient’s age and the area being treated.

It is recommended that treatment with tacrolimus or pimecrolimus be initiated only by physicians (including general practitioners) with a special interest and experience in dermatology, and only after careful discussion with the patient about the potential risks and benefits of all appropriate second-line treatment options.

Tacrolimus and pimecrolimus for atopic eczema August 2004

Only physicians with a specialist interest and experience in dermatology should start treatment with
tacrolimus or primecrolimus, and only after discussing
1) The risks and benefits of all appropriate second line treatment options
2) That topical calcineurin inhibitors should only be applied to areas of active atopic eczema, which may include areas of broken skin

Topical calcineurin inhibitors for facial atopic eczema in children requiring long-term or frequent use of mild topical corticosteroids

Topical tacrolimus or pimecrolimus should not be used for
For mild atopic eczema
As first-line treatment for atopic eczema of any severity
Under bandages or dressings without specialist dermatological advice

If atopic eczema is not controlled by topical corticosteroids, and if there is risk of important adverse effects from topical corticosteroid treatment, options for treatment with topical calcineurin inhibitors are:
Tacrolimus for moderate to severe atopic eczema in children aged 2 years and over
Pimecrolimus for moderate atopic eczema on the face and neck in children aged 2–16 years. NICE CG57 Atopical eczema in Children December 2007