Picato

Posology Actinic keratosis on the face and scalp in adults One tube of Picato 150 mcg/g gel (containing 70 mcg ingenol mebutate) should be applied once daily to the affected area for 3 consecutive days. Optimal therapeutic effect can be assessed approximately 8 weeks after treatment.

A repeat treatment course of Picato can be given if an incomplete response is seen at a follow-up examination after 8 weeks or if lesions that are cleared at this examination recur in subsequent examinations. Paediatric population There is no relevant use of Picato in the paediatric population.

1). Immunocompromised patients Clinical data on treatment in immunocompromised patients is not available, but systemic risks are not expected since ingenol mebutate is not absorbed systemically. g. 5 cm x 5 cm). 6). The gel from the tube should be squeezed onto a fingertip and spread evenly over the entire treatment area, allowing it to dry for 15 minutes.

The content of one tube should be used for one treatment area of 25 cm2. For single use only.

For treatment of the neck:

If more than half of the treatment area is located in the upper part of the neck, Picato 150 mcg/g gel should be used at the posology for face and scalp. If more than half of the treatment area is located in the lower part of the neck, Picato 500 mcg/g gel should be used at the posology for trunk and extremities.

If an area on the face or scalp and another area on the trunk or extremities are simultaneously treated, then patients should be advised to ensure they use the appropriate strengths. Care should be exercised not to apply the Picato 500 mcg/g gel on the face or scalp as this could lead to a higher incidence of local skin responses.

Patients should be instructed to wash their hands with soap and water, immediately after applying Picato and between topical applications if two different areas require different strengths. If treating the hands, only the fingertip which is used for applying the gel should be washed.

Washing and touching the treated area should be avoided for a period of 6 hours after application of Picato. After this period, the treatment area may be washed using mild soap and water. Picato should not be applied immediately after taking a shower or less than 2 hours before bedtime.

Summary of the safety profile The most frequently reported adverse reactions are local skin responses including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration at the application site of ingenol mebutate gel, see table 1 for MedDRA terms.

Following the application of ingenolMedicinal product no longer authorised 5 mebutate, most patients (>95%) experienced one or more local skin response(s). Infection at the application site has been reported when treating face and scalp.

Tabulated list of adverse reactions Table 1 reflects exposure to Picato 150 mcg/g or 500 mcg/g in 499 patients with actinic keratosis treated in four vehicle controlled phase 3 studies enrolling a total of 1,002 patients and post-marketing reports.

Patients received field treatment (area of 25 cm2) with Picato at concentrations of 150 mcg/g or 500 mcg/g or vehicle once daily for 3 or 2 consecutive days respectively. The table below presents adverse reactions by MedDRA system organ class and anatomical location.

Frequencies have been defined according to the following convention:

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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

4 for prevention of eye exposure) ***: Including application site burning. Description of selected adverse reactions The incidence of local skin responses that occurred at an incidence >1% in both the ‘face/scalp’ and the ‘trunk/extremities’, respectively are: application site erythema (94% and 92%), application site exfoliation (85% and 90%), application site scab (80% and 74%), application site swelling (79% and 64%), application site vesicles (13% and 20%), application site pustules (43% and 23%) and application site erosion (31% and 25%).

Eye exposure Contact with the eyes can cause chemical conjunctivitis and corneal burns. Patients should wash their hands thoroughly after applying the gel and following any contact with the treated area, to avoid inadvertent transfer of the gel to the eyes.

If accidental exposure occurs, the eyes should be flushed immediately with large amounts of water, and the patient should seek medical care as soon as possible. 8). Ingestion Picato must not be ingested. If accidental ingestion occurs the patient should drink plenty of water and seek medical care.

General Administration of Picato is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised.

Picato should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips. 8). Localised skin responses are transient and typicallyMedicinal product no longer authorised 4 occur within 1 day of treatment initiation and peak in intensity up to 1 week following completion of treatment.

Localised skin responses typically resolve within 2 weeks of treatment initiation when treating areas on the face and scalp and within 4 weeks of treatment initiation when treating areas on the trunk and extremities. Treatment effect may not be adequately assessed until resolution of local skin responses.

Sun exposure Studies have been conducted to assess the effects of UV irradiation of the skin following single and multiple applications of ingenol mebutate gel, 100 mcg/g. Ingenol mebutate gel did not demonstrate any potential for photo irritation or photo allergic effects.

However, due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised. 1) and post-marketing. Ingenol mebutate should be used with caution in patients with a history of cutaneous malignancy.

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