Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Ameluz

Ameluz 78 mg/g gel · Abschnitt 4.8 · PDF-Seite 6

HOS-213730 · Präparat HOS-155182

In clinical trials with Ameluz, local skin reactions at the application site were observed in most of the subjects treated for actinic keratosis and basal cell carcinoma. This is to be expected as the therapeutic principle of photodynamic therapy is based on phototoxic effects of protoporphyrin IX which is synthesized from the active ingredient 5-aminolaevulinic acid. The most common signs and symptoms are application site irritation, erythema, pain, and oedema. The intensity of these effects is dependent on the type of illumination used for photodynamic therapy. The increased effects correlate with the higher clearance rate of red-light narrow spectrum lamps (see section 5.1). In rare cases, adverse reactions, e.g. pain, required interruption or discontinuation of the illumination. The study of Ameluz using natural and artificial daylight showed similar types of side effects. However, intensity of some adverse reactions, particularly pain, was lower when Ameluz was used in combination with daylight PDT. Most adverse reactions occur during illumination or shortly afterwards. The symptoms are usually of mild or moderate intensity (investigator’s assessment on a 4-point scale), and last for 1 to 4 days in most cases; in some cases, however, they may persist for 1 to 2 weeks or even longer.

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