Ameluz gel

Pronunciation: A-meh-looz
Generic name: aminolevulinic acid HCL 10%
Other brand names of aminolevulinic acid HCL 10% include Ameluz
Dosage form: topical gel
Drug class: Topical photochemotherapeutics

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 31, 2024.

What is Ameluz?

Ameluz gel is used in combination with light therapy to treat mild-to-moderate actinic keratosis (precancerous scaly spots found on sun-damaged skin) of the face and scalp.

• Ameluz is used in combination with the BF-RhodoLED lamp.

Ameluz's mechanism of action involves converting the light-sensitive, prodrug aminolevulinic acid into protoporphyrin IX (PpIX) by exposing it to red light of a specific wavelength and energy generated by the BF-RhodoLED lamp. Activated PpIX forms reactive oxygen species in the presence of oxygen which damages cellular components and eventually destroys the cells that cause actinic keratoses. 

Ameluz gained FDA approval on May 10, 2016. Ameluz belongs to the drug class topical photochemotherapeutics and it is also known as a porphyrin precursor.

Ameluz side effects

The most common side effects of Ameluz are:

• skin reddening
• pain/burning 
• irritation or itching
• swelling or blistering
• scaling of the skin
• scabbing
• skin hardening.

These occur where the gel has been applied.

Serious side effects and warnings

Allergic reactions: Ameluz may cause allergic reactions before photodynamic therapy and should be washed off and suitable treatment started if signs or symptoms of an allergy, such as a rash, redness, or skin swelling occur. Get emergency medical help if you have signs of an allergic reaction such as hives, difficulty breathing, swelling of your face, lips, tongue, or throat, a fast heartbeat, sweating, and loss of consciousness. 

Transient temporary loss of memory: Photodynamic therapy may cause transient amnestic episodes (temporary loss of memory). If observed, your healthcare provider will stop the therapy immediately. If observed after treatment, contact your healthcare provider.

Risk of eye injury: The BF-RhodoLED lamp used in combination with Ameluz can cause eye damage. You and your healthcare provider must wear protective eyewear while operating the BF-RhodoLED lamp.

Photosensitivity: Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment with Ameluz.

Risk of bleeding: Special care should be taken to avoid bleeding in patients with inherited or acquired coagulation disorders. Bleeding must be stopped before the gel is applied.

Eye damage from Ameluz gel. Avoid applying Ameluz to the eyes. Wash your eyes with water if you accidentally get Ameluz inn your eyes.  

Mucous membrane irritation: Avoid direct contact of Ameluz with the mucous membranes. Wash with water in case of accidental contact.

Use of the following medications with Ameluz may increase the intensity of side effects after light exposure related to photodynamic therapy: St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines.

Call your doctor at once if you have:

• eye problems such as eyelid swelling

• skin irritation

• problems with memory, confusion, or disorientation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before receiving this medicine

You should not be treated with this medicine if you are allergic to Ameluz, aminolevulinic acid, or any of the inactive ingredients in the gel, including soybean and phosphatidylcholine.

Before you receive Ameluz, tell your healthcare provider about all your medical conditions, including if:

• you have an allergy to porphyrins
• you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system)
• your skin is especially sensitive to light
• you have a blood clotting problem
• you are pregnant or intending to become pregnant
• you are breastfeeding or intend to breastfeed
• you are taking certain medications that make your skin more sensitive to light such as St. John's wort griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines.

Pregnancy

It is not known if Ameluz will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using this medicine.

How is Ameluz applied?

Treatment with Ameluz involves several steps.

• Your healthcare provider will prepare your skin and apply Ameluz to it. The application area should not exceed 60 cm². The maximum number of Ameluz tubes that can be used in one treatment is three (6 grams of Ameluz).
• You will need to leave Ameluz on your skin for 3 hours to allow the gel to penetrate the skin cells in that area. After this recommended time, your healthcare provider will illuminate the area with the BF-RhodoLED lamp for 10 minutes.
• While you are exposed to the light treatment you and any staff administering the light therapy will need to wear protective eyewear.
• The light therapy has a low intensity and will not heat your skin. However, you may feel tingling, stinging, prickling, or burning where Ameluz was applied. This discomfort is usually temporary.
• Call your doctor if you have severe skin discomfort, or if you have new or worsening skin problems.

You may need to be treated in separate sessions if you have actinic keratoses in more than one area.

See How is Ameluz used to treat actinic keratosis? for more information.

If your actinic keratosis lesions do not clear up completely, you may need another treatment. Your doctor will determine if you need additional treatment with Ameluz.

What happens if I miss a dose?

In a medical setting, you are not likely to miss a dose. Call your doctor for instructions if you miss an appointment for your light treatment within the recommended time.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly. Your healthcare provider should not treat an area of skin larger than 60 cm². A maximum of 3 Ameluz tubes may be used in one treatment session.

What should I avoid after receiving Ameluz?

Ameluz could make you more sensitive to light. Stay out of direct sunlight and avoid strong or extended light exposure for before and 48 hours after Ameluz is applied to the affected skin. Sunscreens will not protect you against a reaction. Wear a hat and clothing that covers your skin.

Do not get this medicine in your eyes, nose, mouth, or ears. If contact does occur, rinse with water.

Avoid using other medications on the areas treated with Ameluz unless your doctor tells you to.

What other drugs will affect Ameluz?

Tell your doctor about all your other medicines. Some drugs can make you more sensitive to sunlight, especially:

• an antibiotic or sulfa drugs

• griseofulvin

• a diuretic or "water pill"

• St. John's wort

• medicine to treat nausea or vomiting

• medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia

• an oral diabetes medicine.

This list is not complete. Other drugs may affect Ameluz, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ameluz ingredients

Active ingredients: aminolevulinic acid hydrochloride 100 mg per gram (equivalent to 78 mg aminolevulinic acid).

Inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, propylene glycol, sodium benzoate, and purified water.

Each Ameluz tube contains 2 grams of gel. A maximum of 3 tubes (6 grams) may be used at each treatment session.

Ameluz storage

Store Ameluz in a refrigerator at 2°C – 8°C (36°F – 46°F). Excursions permitted to 15°C – 30°C (59°F – 86°F).

After opening, Ameluz can be stored for up to 12 weeks in a refrigerator at 2°C – 8°C (36°F – 46°F) if the tube is tightly closed.

Who makes Ameluz?

Biofrontera Pharma GmbH makes Ameluz.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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