Posology in adults For treatment of actinic keratoses (AK) of the face or scalp, one session of photodynamic therapy (with natural daylight or a red-light or artificial daylight lamp) shall be administered for single or multiple lesions or entire fields with cancerization (areas of skin where multiple AK lesions are surrounded by an area of actinic and sun-induced damage within a limited field).
For treatment of actinic keratoses (AK) in the body region trunk, neck or extremities, one session of narrow spectrum red-light photodynamic therapy shall be administered. Actinic keratosis lesions or fields shall be evaluated three months after treatment.
Treated lesions or fields that have not completely resolved after 3 months shall be retreated. For treatment of basal cell carcinoma (BCC), two sessions of photodynamic therapy with red-light lamp shall be administered for one or multiple lesions with an interval of about one week between sessions.
Basal cell carcinoma lesions shall be evaluated three months after last treatment. Treated lesions that have not completely resolved after 3 months shall be retreated. Paediatric population There is no relevant use of Ameluz in the paediatric population.
No data are available. Method of administration Ameluz is for cutaneous use. Ameluz should be administered under the guidance of a physician, a nurse or other healthcare professional experienced in the use of photodynamic therapy. When a red-light or an artificial daylight lamp is required, the treatment should be performed by a healthcare professional.
Treatment of AK, field cancerization and BCC using a red-light lamp: a) Preparation of the lesions: Before administration of Ameluz, all lesions should be carefully wiped with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.
Scales and crusts should be removed accurately and all lesion surfaces roughened gently. Care should be taken to avoid bleeding. Nodular BCC lesions are often covered by an intact epidermal keratin layer which should be removed. Exposed tumour material should be removed gently without any attempt to excise beyond the tumour margins.
b) Application of the gel: Ameluz should be applied to the lesion area or entire cancerized fields and approximately 5 mm of the surrounding area in a film of about 1 mm thickness (about 20 cm2 area per tube). The gel should be applied using glove- protected fingertips or a spatula, and it should be allowed to dry for approximately 10 minutes, before a light-tight dressing is placed over the treatment site.
Following 3 hours of incubation, the dressing should be removed and the remnant gel wiped off. The gel can be administered to healthy skin around the lesions. Direct contact of Ameluz with the eyes or mucous membranes should be avoided (keep a distance of 1 cm).
In case of accidental contact, rinsing with water is recommended. c) Illumination: After cleaning the lesions, the entire treatment area will be illuminated with a red light source, either with a narrow-spectrum around 630 nm and a light dose of approximately 37 J/cm2 or a broader and continuous spectrum in the range between 570 and 670 nm with a light dose between 75 and 200 J/cm2.
It is important to ensure that the correct light dose is administered. The total light dose is determined by factors such as the irradiance (or equivalent), the size of the light field, the distance between lamp and skin surface, and the illumination time.
These factors vary with lamp type. The light dose delivered should be monitored if a suitable detector is available. During illumination the lamp should be fixed at the distance from the skin surface that is indicated in the user manual.
6. A narrow-spectrum lamp is recommended to achieve higher clearance rates. Symptomatic treatment of transient adverse site reactions may be considered. 1).
Note:
Efficacy of Ameluz in the treatment of AK in the body regions trunk, neck and extremities has been demonstrated only in the scope of narrow-spectrum PDT. There are no data for these body regions with broader spectrum lamps PDT or with natural or artificial daylight PDT.
Lesions should be re-assessed after three months, at which point any residual lesions or fields may be retreated. It is recommended that the response of BCC lesions may be confirmed by histological examination of biopsy material, if considered necessary.
Subsequently, close long-term clinical monitoring of BCC is recommended, with histology if necessary. Treatment of AK and field cancerization of the face and scalp with natural or artificial daylight: a) Considerations before treatment: Natural daylight PDT should only be used if the conditions are suitable to stay comfortably outdoors for two hours (with temperatures > 10 °C).
If the weather is rainy, or is likely to become so, natural daylight treatment should not be used. For natural daylight PDT, sunscreen should be applied 15 min prior to lesion pretreatment in order to protect sun exposed skin. Only sunscreen with chemical filters and SPF 30 or higher should be used.
Sunscreens with physical filters such as titanium dioxide, zinc oxide, etc. should not be used, as these inhibit light absorption and may therefore impact efficacy. For artificial daylight PDT, sunscreen is not needed, as patients are not exposed to ultraviolet light during illumination.
b) Preparation of the lesions: Before administration of Ameluz, all lesions should be carefully wiped with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin. Scales and crusts should be removed accurately and all lesion surfaces roughened gently.
Care should be taken to avoid bleeding. c) Application of the gel: A thin layer of Ameluz should be applied to the lesion area or entire cancerized fields and approximately 5 mm of the surrounding area using glove […]