What is Ameluz - 5-Aminolevulinic Acid?
Ameluz is a medicine that contains the active substance 5-aminolevulinic acid, available as a gel (78 mg / g).
What is Ameluz used for?
Ameluz is indicated for the treatment of mild to moderate actinic keratosis (abnormal thickening of the skin due to excessive exposure to sunlight) on the face and scalp.
The medicine can only be obtained with a prescription.
How is Ameluz used?
Ameluz should only be administered under the supervision of a healthcare professional experienced in the use of photodynamic therapy. This method of treatment requires the area to be briefly illuminated with an appropriate source of intense red light. The red light activates the photosensitizing agent. present in the Ameluz gel.
Ameluz is applied to skin lesions three hours prior to red light source therapy. One or more injuries can be treated in one session. The state of the lesion must be evaluated three months after treatment. Any residual lesions must be treated again.
How does Ameluz - 5-aminolevulinic acid work?
Ameluz is used as part of a photodynamic therapy, a technique that involves the "illumination of" an area of skin previously sensitized to light. When Ameluz is applied to skin lesions in patients with actinic keratosis, the active ingredient contained in the gel, 5-aminolevulinic acid, is absorbed by skin cells, where it acts as a photosensitizing agent (a substance that changes when exposed to a certain wavelength). When the area to be treated is exposed to light, the agent The photosensitizer activates and reacts with the oxygen present in the cells, releasing an extremely reactive and toxic type of oxygen, which destroys the cells by reacting with their components, including proteins and DNA.
How has Ameluz - 5-aminolevulinic acid been studied?
The effects of Ameluz were first tested in experimental models before being studied in humans.
The effects of Ameluz in photodynamic therapy were investigated in two main studies involving patients with actinic keratosis. In the first study, involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolevulinate, over one or two treatment sessions. In the second study, involving 122 patients, Ameluz was compared with placebo over one or two treatment sessions. In both studies, the main measure of effectiveness was the overall number of patients in whom complete remission of actinic keratoses was observed three months after the last treatment.
What benefit has Ameluz - 5-aminolevulinic acid shown during the studies?
Ameluz was more effective than placebo and comparator in the treatment of actinic keratosis with photodynamic therapy. In the first study, actinic keratosis had disappeared three months after treatment in 78% (194 out of 248) of patients treated with Ameluz compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 246) of patients treated with 76) of patients treated with placebo. In the second study, actinic keratosis had disappeared within three months of treatment in 66% (53 out of 80) of the patients treated with Ameluz compared with 13% (5 out of 40) of the patients treated with placebo.
What is the risk associated with Ameluz - 5-aminolevulinic acid?
The most common side effects with Ameluz (seen in more than 1 in 10 patients) are irritation, erythema (redness of the skin), pain, itching, edema (swelling), peeling of the skin, crusting and hardening. For the full list of side effects reported with Ameluz, see the package leaflet.
Ameluz must not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid, porphyrins or any of the other ingredients. It should also not be used in people with porphyria (inability to synthesize chemicals called porphyrins). or in subjects with certain skin diseases of different origin caused by exposure to light. For the full list of restrictions, see the package leaflet.
Why has Ameluz - 5-Aminolevulinic Acid been approved?
The CHMP concluded that the benefits of treatment with Ameluz outweigh its rare and mostly mild side effects, and that Ameluz is more effective and somewhat safer than the standard therapeutic alternative. Therefore, the CHMP decided. that the benefits of Ameluz outweigh its risks and recommended that it be given a marketing authorization for the medicine.
Other information about Ameluz - 5-aminolevulinic acid
On 14 December 2011, the European Commission issued a "Marketing Authorization" for Ameluz, valid throughout the European Union.
For more information about Ameluz therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 11-2011.
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