PICATO Gel Ref.[9589] Active ingredients: Ingenol mebutate

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.

Elderly population

No dose adjustment is required (see section 5.1).

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.

Method of administration

The content of one tube covers a treatment area of 25 cm² (e.g. 5 cm x 5 cm). The tube is for single use only and should be discarded after use (see section 6.6).

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.

The treated area should not be covered with occlusive bandages after Picato is applied.

Overdosing of Picato could result in an increased incidence of local skin responses. Management of overdose should consist of treatment of clinical symptoms.

Shelf life: 2 years.

Store in a refrigerator (2ºC-8ºC).

Tubes should be discarded after first opening.

Single-dose laminate tubes with inner layer of High Density Polyethylene (HDPE) and aluminium as the barrier layer. Caps of HDPE.

Picato 150 mcg/g gel is available in a carton containing 3 tubes with 0.47 g of gel each

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