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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, Actinic
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Treatment of actinic keratosis of mild to moderate severity on the face and scalp and of field cancerization.

What is Ameluz and what is it used for?

Ameluz is a gel used to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition. Actinic keratoses are skin growths caused by over exposure to sunlight, which can lead to skin cancer.

Ameluz contains the active substance 5-aminolaevulinic acid.

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 directly to the skin growths or to the entire area affected by the growths and, three hours later, a red light source is shone onto the skin. 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.

The medicine can only be obtained with a prescription.

How does Ameluz work?

When Ameluz is applied to the abnormal skin growths, 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.

What benefits of Ameluz have been shown in studies?

Studies using different red light sources used for illumination have shown that Ameluz is effective in treating actinic keratoses when applied directly to the skin growths. In one study in 571 patients, the actinic keratoses cleared up three months after treatment for 78% of patients treated with Ameluz, compared with 64% of patients treated with methylaminolevulinate (a comparator medicine) and 17% of patients treated with placebo (a dummy treatment). In another study in 122 patients, the actinic keratoses cleared up three months after treatment for 66% of patients treated with Ameluz, compared with 13% of patients treated with placebo.

A third study in 87 patients compared Ameluz with placebo when applied to the entire area affected by actinic keratoses. In this study, after 12 weeks of treatment the skin growths cleared up in 91% of patients treated with Ameluz compared with 22% of patients treated with placebo.

What are the risks 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 is Ameluz approved?

The Agency’s Committee for Medicinal Products for Human Use (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.

What measures are being taken to ensure the safe and effective use of Ameluz?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ameluz have been included in the summary of product characteristics and the package leaflet.

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.