Appendix G

Rx Tacrolimus 0.1%

Tacrolimus is a calcineurin inhibitor. It suppresses T-cell activation by binding to the intracellular protein FKBP-12 and complexes with calcineurin dependent proteins resulting in decreased calcineurin phosphatase activity and reduced downstream activation of T lymphocytes.

Indications: Second line topical treatment of moderate to severe OLP, MMP, and PV.

Contraindications: Hypersensitivity to the drug or any component of the formulation. Fungal, viral or bacterial infections of the oral cavity or throat.

Warnings/Precautions: Avoid use on malignant or premalignant skin conditions. Limit sun and ultraviolet light exposure; use appropriate sun protection. Do not use on areas of active bacterial or viral infection. Avoid in patients with atopic dermatitis. Do not use in immunocompromised patients.

Drug interactions: No significant drug interactions reported.

Administration:
Dosage form – 0.1% ointment.
Topical – Apply thin coating of ointment to lesion 2 to 4 times per day. Do not eat or drink for 30 minutes.

Monitor efficacy: Improved oral comfort, lesion resolution.

Monitor toxicity: Mucosal thinning, burning, and candidal superinfection.

Length of treatment: As may be required to manage painful exacerbations of OLP.

Cessation of treatment: Topical regimens may be discontinued without tapering.

Instructions to the patient: Use only as instructed. Do not swallow.

For additional information see DailyMed