Actinic keratosis

Active Ingredient: Tirbanibulin

Indication for Tirbanibulin

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Tirbanibulin is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

For this indication, competent medicine agencies globally authorize below treatments:

A thin layer of ointment once daily for 5 consecutive days

For:

Dosage regimens

Cutaneous, 1 spreads tirbanibulin, once daily, over the duration of 5 days.

Detailed description

Tirbanibulin ointment should be applied to the affected field on the face or scalp once daily for one treatment cycle of 5 consecutive days. A thin layer of ointment should be applied to cover the treatment field of up to 25cm².

If a dose is missed, the patient should apply the ointment as soon as he/she remembers and then he/she should continue with the regular schedule. However, the ointment should not be applied more than once a day.

Tirbanibulin ointment should not be applied until the skin is healed from treatment with any previous medicinal product, procedure or surgical treatment and should not be applied to open wounds or broken skin.

Therapeutic effect can be assessed approximately 8 weeks after treatment starts. If the treated area does not show complete clearance at the follow-up examination, about 8 weeks after the treatment cycle started or thereafter, the treatment should be re-evaluated and management re-considered.

No clinical data on treatment for more than 1 treatment course of 5 consecutive days are available. If recurrence occurs, or new lesions develop within the treatment area, other treatment options should be considered.

Dosage considerations

Before applying tirbanibulin, patients should wash the treatment field with mild soap and water and dry it.

The ointment should be applied at approximately the same time each day. The treated area should not be bandaged or otherwise occluded. Washing and touching of the treated area should be avoided for approximately 8 hours after application of tirbanibulin. After this period, the treated area may be washed with mild soap and water.

Hands should be washed with soap and water before and immediately after application of the ointment.

Active ingredient

Tirbanibulin

Tirbanibulin disrupts microtubules by direct binding to tubulin, which induces cell cycle arrest and apoptotic death of proliferating cells, and is associated with disruption of Src tyrosine kinase signalling.

Read more about Tirbanibulin

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