AMELUZ Gel Ref.[116233] Active ingredients: Aminolevulinic acid

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. See also section 6.6.

A narrow-spectrum lamp is recommended to achieve higher clearance rates. Symptomatic treatment of transient adverse site reactions may be considered. A broader and continuous spectrum may be used if narrow-spectrum light sources are not tolerated (see sections 4.8 and 5.1).

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-protected fingertips or a spatula. No occlusive dressing is necessary during incubation. It can be used optionally for artificial daylight PDT, but it should be removed before illumination at the latest. The gel can be administered to healthy skin around the lesions. Direct contact of Ameluz with the eyes or mucous membrane should be avoided (keep a distance of 1 cm). In case of accidental contact, rinsing with water is recommended. The gel should not be wiped off during the entire daylight PDT.

d) Incubation and illumination using daylight for AK treatment:

Natural daylight PDT:

If conditions are suitable (see section a. Considerations before treatment), patients shall go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight. Taking shelter in the shade in hot weather is acceptable. Interruption of the time outdoors should be compensated by a longer illumination time. Remaining gel should be removed after completion of light exposure.

Artificial daylight PDT:

To ensure sufficient protoporphyrin IX (PpIX) synthesis, the total treatment time (covering incubation and illumination) should be 2 hours and should not exceed 2.5 hours. However, illumination should start within 0.5 to 1 hour after gel application to avoid excessive PpIX accumulation, which might lead to increased pain sensation. The illumination time may vary due to different characteristics (e.g. irradiance and light spectrum) of the CE marked medical devices for artificial daylight PDT. The devices should have either a continuous or an intermittent spectrum covering one or more of the PpIX absorption peaks/bands in the range between 400 and 750 nm. All studied artificial daylight devices with proven PpIX activating activity at least addressed the red PpIX absorption peak at about 631 nm. In order to ensure that the correct light dose is administered, light dose and illumination conditions recommended in the user manuals of the artificial daylight devices should be considered. However, the minimal applied dose at the lesions surface should not be less than ~14 J/cm². Patient and operator should adhere to safety instructions provided with the light source. Remaining gel should be removed after completion of light exposure.

Lesions should be re-assessed after three months, at which point any residual lesions or fields may be retreated.

Overdose following topical administration is unlikely and has not been reported in clinical studies. If Ameluz is accidentally ingested, systemic toxicity is unlikely. Protection from sun light exposure for 48 hours and observation are nevertheless recommended.

Unopened tube: 24 months.

After first opening: 4 months.

Store in a refrigerator (2°C – 8°C).

Keep the tube tightly closed after first opening.

One outer carton containing one aluminium tube with epoxyphenol inner lacquer and a latex seal and a screw cap of high density polyethylene. Each tube contains 2 g of gel.

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

Each lamp should be used according to the user manual. Only CE marked lamps should be used, equipped with the necessary filters and/or reflecting mirrors to minimiz e exposure to heat, blue light (only for red-light PDT) and ultra violet (UV) radiation. The technical specifications of the device need to be checked before using a specific light source, and the requirements must be met for the intended light spectrum. Both the patient and the medical personnel conducting the photodynamic therapy should adhere to any safety instructions provided with the light source used. During illumination, patient and medical personnel should wear suitable protective goggles for red-light PDT and where recommended for artificial daylight PDT. There is no need to protect healthy untreated skin surrounding the treated lesions.