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Ameluz

Active Substance: 5-aminolevulinic acid hydrochloride
Common Name: 5-aminolevulinic acid hydrochloride
ATC Code: L01XD04
Marketing Authorisation Holder: Biofrontera Bioscience GmbH
Active Substance: 5-aminolevulinic acid hydrochloride
Status: Authorised
Authorisation Date: 2011-12-14
Therapeutic Area: Keratosis
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Treatment of actinic keratosis of mild to moderate intensity on the face and scalp (Olsen grade 1 to 2).

What is Ameluz?

Ameluz is a medicine that contains the active substance 5-aminolaevulinic acid. It is available as a gel (78 mg/g).

What is Ameluz used for?

Ameluz is used to treat mild to moderate actinic keratosis (abnormal skin growths that develop after too much exposure to sunlight, which can lead to skin cancer) on the face and scalp.

The medicine can only be obtained with a prescription.

How is Ameluz used?

Ameluz should only be given under the supervision of a healthcare professional experienced in using photodynamic therapy. This method of treatment involves applying a brief illumination from a strong red light source designed for this purpose. Red light activates the photosensitising agent in the Ameluz gel.

Ameluz is applied to the skin growths and, three hours later, a red light source is shone onto them. Single or multiple growths may be treated in one session. The state of the growths should be monitored three months later, and any remaining growths should be re-treated.

How does Ameluz work?

Ameluz is used in photodynamic therapy, a technique that involves shining a light on an area of skin which has been made sensitive to the light. When Ameluz is applied to the abnormal skin growths in actinic keratosis, the active substance in Ameluz, 5-aminolaevulinic acid, is absorbed into their cells where it acts as a photosensitising agent (a substance that changes when exposed to light of a certain wavelength). When the affected skin is illuminated with the light, the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen. This kills the cells by reacting with and destroying their components, such as proteins and DNA.

How has Ameluz 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 examined in two main studies in patients with actinic keratosis. In the first main study involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used for one or two treatment sessions. In the second main study involving 122 patients, Ameluz was compared with placebo used for one or two treatment sessions. The main measure of effectiveness in both studies was the total number of patients with all actinic keratoses had cleared up three months after the last treatment.

What benefit has Ameluz shown during the studies?

Ameluz was more effective than placebo and the comparator medicine when used in photodynamic therapy to treat actinic keratosis. In the first study, the actinic keratosis had cleared up three months after treatment for 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 76) of patients treated with placebo. In the second study, the actinic keratosis had cleared up three months after treatment for 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.

What is the risk associated with Ameluz?

The most common side effects with Ameluz (seen in more than 1 patient in 10) are reactions at the site of application, including irritation, erythema (reddening of the skin), pain, pruritus (itching), oedema (swelling), exfoliation (skin peeling), scab formation and induration (hardening of the skin). For the full list of all side effects reported with Ameluz, see the package leaflet.

Ameluz must not be given to people who are hypersensitive (allergic) to 5-aminolaevulinic acid, porphyrins or any of the other ingredients. It must not be used in people who have porphyria (an inability to break down chemicals called porphyrins) or people who have certain skin diseases of different origins caused by exposure to light. For the full list of restrictions, see the package leaflet.

Why has Ameluz been approved?

The CHMP concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative. The Committee therefore concluded that the benefits of Ameluz are greater than its risks and recommended that it be granted marketing authorisation.

Other information about Ameluz

The European Commission granted a marketing authorisation valid throughout the European Union for Ameluz on 14 December 2011.

For more information about treatment with Ameluz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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