Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Almirall Hermal GmbH, Scholtzstrasse 3, 21465 Reinbek, Germany
Actikerall is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adult patients.
Grade I/II intensity is based on the 4-point scale of Olsen et al. (1991), see section 5.1.
Actikerall should be applied once daily to the affected area (up to 25 cm²) until the lesions have completely cleared or for up to a maximum of 12 weeks. If severe side effects occur, reduce the frequency of drug application to three times per week until the side effects improve. If areas of skin with a thin epidermis are treated, the solution should be applied less frequently and the course of the therapy monitored more often.
Response can be seen as early as in four weeks (see section 5.1). Response increases over time and data are available for treatment up to 12 weeks. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to eight weeks after treatment cessation. Treatment should be continued, although response is not apparent after the first four weeks.
When assessing options to treat recurrent lesions, the physician should consider that the efficacy of retreatment with Actikerall has not been formally measured in clinical trials.
There is no relevant use of Actikerall in the paediatric population for the indication of actinic keratosis.
No dose adjustment is necessary.
Actikerall is intended for cutaneous use only. There is experience in treating up to ten single lesions at the same time. Multiple actinic keratoses and surrounding skin can be treated simultaneously, when field treatment is preferred. The total area of skin being treated with Actikerall at any one time should not exceed 25 cm² (5 cm x 5 cm).
Actikerall is applied by use of the brush applicator connected to the closure cap. To avoid overloading the brush with solution, the brush should be wiped off in the neck of the bottle before application, although allowing enough product for film formation upon drying.
The treated area should not be covered after application and the solution should be left to dry to form a film over the applied area. Each time Actikerall is reapplied the existing film should be removed beforehand by gently peeling it off. Warm water may help to remove the film. Actikerall should not be applied to hairy skin. Use on hairy skin can lead to conglutination of hair in the affected area. When applied to hairy skin a shave or other suitable methods of hair removal should be considered prior to any application of Actikerall.
When applied on the skin as recommended, systemic intoxication with either active is unlikely. Significantly more applications than recommended result in an increase of frequency of reactions at the application site and their severity.
2 years.
Shelf life after opening: 3 months.
Do not store above 25°C.
Do not refrigerate or freeze.
Keep the bottle tightly closed to prevent drying up.
This medicinal product is packed in a brown glass bottle with a child resistant closure of white polypropylene in a cardboard carton. The closure of the bottle is connected to a brush to apply the solution. The brush applicator (CE mark) consists of polyethylene (HDPE and LDPE 1:1) with brush hairs of nylon secured in shaft with stainless steel (V2A).
Pack size: 25 ml cutaneous solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
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