Tacrolimus (Topical)

Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established

• Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including PROTOPIC Ointment.
• Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
• PROTOPIC Ointment is not indicated for use in children less than 2 years of age. Only 0.03% PROTOPIC Ointment is indicated for use in children 2-15 years of age.

FDA and Industry Communications

Dear Health Professional Letter (January 2006)

Tacrolimus (marketed as Protopic Ointment) Information

Protopic (tacrolimus), Elidel (pimecrolimus)

Information for Healthcare Professionals: Tacrolimus (marketed as Protopic)

Patient Counseling Information

Protopic

Medication Guides

Patient Medication Guide

Package Inserts

Tacrolimus

Additional Information

• PubMed - Tacrolimus (Topical) and Long-term Safety of Topical Calcineurin Inhibitors