KLISYRI

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 25 cm2.

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. 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. 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. 2). 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. 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. 4.

Summary of the safety profile The most frequently reported adverse reactions are local skin reactions. Local skin reactions included erythema (91 %), flaking/scaling (82 %), crusting (46 %), swelling (39 %), erosion/ulceration (12 %), and vesiculation/pustulation (8 %) at the application site.

9 %) have been reported in the treatment area. Tabulated list of adverse reactions Table 1 lists the adverse reactions that were reported in clinical studies. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data).

Table 1:

Adverse reactions MedDRA System Organ Class Preferred term Frequency Application site erythema Very common Application site exfoliation (flaking and scaling) Very common Application site scab (crusting) Very common Application site swelling Very common Application site erosion (includes ulcer) Very common Application site paina Common Application site pruritus Common General disorders and administration site conditions Application site vesicles (includes pustules) Common a) Application site pain includes pain, tenderness, stinging, and burning sensation at the application site.

Description of selected adverse reactions Local skin reactions Most local skin reactions were transient and mild to moderate in severity. Following the application of tirbanibulin ointment, the incidences of local skin reactions with a severity grade greater than baseline were erythema (91 %), flaking/scaling (82 %), crusting (46 %), swelling (39 %), erosion/ulceration (12 %), and vesiculation/pustulation (8 %).

Severe local skin reactions occurred at an overall incidence of 13 %. Severe local skin reactions that occurred at an incidence >1 % were: flaking/scaling (9 %), erythema (6 %), and crusting (2 %). None of the local skin reactions required treatment.

Incorrect route of administration Contact with the eyes should be avoided. Tirbanibulin ointment may cause eye irritation. In the event of accidental contact with the eyes, the eyes should be rinsed immediately with large amounts of water, and the patient should seek medical care as soon as possible.

Tirbanibulin ointment must not be ingested. If accidental ingestion occurs, the patient should drink plenty of water and seek medical care. Tirbanibulin ointment should not be used on the inside of the nostrils, on the inside of the ears, or on the lips.

2). 8). Treatment effect may not be adequately assessed until resolution of local skin reactions. Sun exposure Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.

Immunocompromised patients Tirbanibulin ointment should be used with caution in immunocompromised patients. Risk of progression to skin cancer Changes in the appearance of actinic keratosis could suggest progression to invasive squamous cell carcinoma.

Clinically atypical lesions for actinic keratosis or suspicious for malignancy should be appropriately managed. 5 mg propylene glycol in each sachet which is equivalent to 890 mg/g.

1.