Ameluz and BLU-U photodynamic therapy is a 2-part treatment indicated for the treatment of minimally to moderately thick actinic keratoses. Ameluz Topical Solution is applied to the AK. The solution is then absorbed by the AK cells where it is converted to a chemical that makes the cells extremely sensitive to light. When the AK cells are exposed to the BLU-U, Blue Light Photodynamic Therapy Illuminator, a reaction occurs which destroys the AK cells.
What are Actinic Keratoses?
Actinic Keratoses (AKs) are rough-textured, dry scaly patches on the skin that are caused by excessive exposure to ultraviolet light (UV) such as sunlight. Up to 58 million Americans have AKs.
• AKs are often called “sun spots”
• They occur most often on areas such as the face, scalp, and ears
• They can range in color from skin toned to reddish brown
• They can be as small as a pinhead or larger than a quarter
Important Risk Information
Ameluz plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.
Application of Ameluz should involve either scalp or face lesions, but not both simultaneously. Ameluz should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces. Excessive irritation may be experienced if this product is applied under occlusion.
Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the Ameluz for Topical Solution.
Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light for at least 48 hours after Ameluz application. Exposure may result in a stinging and/or burning sensation and may cause redness or swelling of the lesions. Patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light.
The most common side effects include scaling/crusting, skin discoloration, itching, stinging and/or burning, redness and swelling. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during treatment.