AMELUZ Gel Ref.[27465] Active ingredients: Aminolevulinic acid

2.1 Important Administration Information

AMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider.

AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use.

Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED light. Retreat lesions that have not completely resolved after 3 months after the initial treatment.

Refer to BF-RhodoLED user manual for detailed lamp safety and operating instructions. Both patient and medical personnel conducting the PDT should adhere to all safety instructions.

2.2 Dosage and Administration Instructions

PDT is a multi-stage process:

Step 1. Preparation of Lesions:

Before applying AMELUZ, carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.

Figure 1A. Degreasing the skin:

Thereafter, remove any scaling and crusts and gently roughen all lesion surfaces, taking care to avoid bleeding.

Figure 1B. Removal of scales and crust:

Step 2. Application of AMELUZ

Use glove protected fingertips or a spatula to apply AMELUZ. Apply gel approximately 1 mm thick and include approximately 5 mm of the surrounding skin. Use sufficient amount of gel to cover the single lesions or if multiple lesions, the entire area. Application area should not exceed 20 cm² and no more than 2 grams of AMELUZ (one tube) should be used at one time. The gel can be applied to healthy skin around the lesions. Avoid application near mucous membranes such as the eyes, nostrils, mouth, and ears (keep a distance of 1 cm from these areas). In case of accidental contact with these areas, thoroughly rinse with water. Allow the gel to dry for approximately 10 minutes before applying occlusive dressing.

Figure 2. Drug application:

Step 3. Occlusion for 3 Hours

Cover the area where the gel has been applied with a light-blocking, occlusive dressing. Following 3 hours of occlusion, remove the dressing and wipe off any remaining gel.

Figure 3. Occlusion:

Step 4. Illumination with Red Light

During illumination, patient and medical personnel need to wear suitable protective eyewear.

Immediately after removing occlusion and any remaining gel, illuminate the treatment area with BF-RhodoLED, a red light source with a narrow spectrum around 635 nm that delivers a light dose of approximately 37 J/cm² within 10 minutes. Calibration by the operator is not needed; the illumination time is calculated automatically. Position the lamp head 5-8 cm from the skin’s surface. When an area of 8 × 18 cm is illuminated, the effective treatment area is 6 x16 cm. Larger areas can be illuminated in several steps.

Healthy untreated skin surrounding the AK lesions does not need protection during illumination.

Figure 4. Illumination:

If for any reason, the lesions cannot be illuminated within 3 hours after AMELUZ application, rinse off the gel with saline and water. For 2 days, protect the lesion sites and surrounding skin from sunlight or prolonged or intense light (e.g., tanning beds, sun lamps).

Store AMELUZ in a refrigerator, 2°C–8°C (36°F–46°F). Excursions permitted to 15°C–30°C (59°F–86°F).

After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C–8°C (36°F–46°F) if the tube is tightly closed.