KLISYRI Ointment Ref.[27964] Active ingredients: Tirbanibulin

Posology

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 (see section 4.4).

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 (see section 4.4). If recurrence occurs, or new lesions develop within the treatment area, other treatment options should be considered.

Special populations

Hepatic or renal impairment

Tirbanibulin has not been studied in patients with renal or hepatic impairment. Based on clinical pharmacology and in vitro studies, no dose adjustments are needed (see section 5.2).

Elderly population

No dose adjustment is required (see section 5.1).

Paediatric population

There is no relevant use of Klisyri in the paediatric population for the indication of actinic keratosis.

Method of administration

Tirbanibulin ointment is for external use only. Contact with eyes, lips, and the inside of nostrils or ears should be avoided.

Each sachet is for single use only and should be discarded after use (see section 6.6).

Treatment should be initiated and monitored by a physician.

Before applying tirbanibulin, patients should wash the treatment field with mild soap and water and dry it. Some ointment from 1 single-use sachet should be squeezed onto a fingertip and a thin layer applied evenly over the entire treatment field of up to a maximal treatment area of 25 cm².

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.

Tirbanibulin ointment is for application on the face or scalp. For information on incorrect route of administration, see section 4.4.

Overdose following topical application with tirbanibulin ointment may cause an increase in incidence and severity of local skin reactions. No systemic signs of overdose are expected following topical application of tirbanibulin ointment due to the low systemic absorption of tirbanibulin. Management of overdose should consist of treatment of clinical symptoms.

For information on incorrect routes of administration, see section 4.4.

3 years.

Do not refrigerate or freeze.

Sachets with an inner layer of linear low-density polyethylene. Each sachet contains 250 mg of ointment.

Packs of 5 sachets.

Sachets should be discarded after first use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.