tirbanibulin: clinical use

Prescribing considerations

• Confirm lesions are clinically typical, mild, non-hyperkeratotic and non-hypertrophic actinic keratoses on the face or scalp.
• Do not initiate treatment over broken skin or before recovery from previous topical treatment, procedures or surgery.
• Use caution in immunocompromised patients because clinical experience is limited.
• Reassess after local reactions settle; incomplete clearance, recurrence or new lesions requires management review.
• Minimise excessive sunlight, sunlamp and tanning-bed exposure.
• The product remains under additional monitoring.

Contraindications and cautions

• Hypersensitivity to tirbanibulin or any excipient.
• Avoid ocular, oral, intranasal, intra-aural and lip application.
• Not recommended during pregnancy or when pregnancy is possible without contraception.

Monitoring

• Assess local erythema, scaling, crusting, swelling, erosion, blistering, pain and pruritus.
• Examine atypical, ulcerated, raised or changing lesions for possible invasive squamous cell carcinoma.
• Evaluate clinical response after treatment-area inflammation has resolved.
• Report suspected adverse reactions through the Yellow Card scheme.

Clinical pharmacology

Tirbanibulin binds tubulin, disrupting microtubules and causing cell-cycle arrest and apoptosis in proliferating cells; Src signalling is also disrupted. Systemic absorption after topical use is minimal. In vitro metabolism is mainly through CYP3A4, with a lesser contribution from CYP2C8, but clinically meaningful metabolic interactions are considered unlikely at expected exposure.

Formulation and product differences

• The ointment contains propylene glycol and glycerol monostearate.
• It is supplied in single-use sachets that must be discarded after opening.
• Do not refrigerate or freeze.

Ointment

Route: Cutaneous

Strengths: 10 mg/g