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 or RhodoLED XL light. Retreat lesions that have not completely resolved after 3 months after the initial treatment.

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

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 the BF-RhodoLED or RhodoLED XL lamp. BF-RhodoLED and RhodoLED XL lamps are red light sources with a narrow spectrum around 635 nm that deliver a light dose of approximately 37 J/cm2 within 10 minutes. Calibration by the operator is not needed; the illumination time is calculated automatically.

Either the BF-RhodoLED or RhodoLED XL lamp can be used:

• BF-RhodoLED has an effective treatment area of 6 x 16 cm when an area of 8 x 18 cm is illuminated. Position the lamp head 5-8 cm from the skin’s surface. Larger areas can be illuminated in several steps.
• RhodoLED XL has a curved configuration with an effective treatment area up to 23 x 29 cm. Position the lamp head of the RhodoLED XL 11-14 cm from the skin’s surface. This usually allows a full-face illumination with the use of 5 panels. The smallest recommended number of panels to be used are 3 adjacent panels (see chapter 8.4.6 of RhodoLED XL user manual).

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

Figure 4A: Illumination with BF-RhodoLED

Figure 4B: Illumination with RhodoLED XL

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).