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AMELUZ (aminolevulinic acid HCl) topical gel, 10% with RhodoLED logo
FOR US AUDIENCES ONLY

What is photodynamic therapy (PDT)?

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PDT is a quick, non-invasive, non-scarring, in-office treatment1-3

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PDT with AMELUZ® (aminolevulinic acid HCI) topical gel, 10% and RhodoLED® red light can treat several AKs in one area2

Icon of a woman with stars on each side of her face indicating smooth skin.

Following PDT, most AK lesions will have cleared—revealing smoother-looking skin1

What is AMELUZ® (aminolevulinic acid HCI) topical gel, 10%?

AMELUZ® is a topical gel used in combination with the RhodoLED® lamp series red light for PDT for the treatment of mild-to-moderate actinic keratosis on the face and scalp.2

Tube of ameluz gel.

What is RhodoLED® XL?

RhodoLED® XL is a 5-panel LED lamp that emits a deep-penetrating red light that activates the PDT treatment.1,4,5

Photo of RhodoLED XL lamp.
Photo of RhodoLED XL lamp.

What is BF‑RhodoLED®?

BF-RhodoLED® is an LED lamp that emits a deep-penetrating red light that activates the PDT treatment.1,4

Photo of BF-RhodoLED
Photo of BF-RhodoLED

How AMELUZ® and BF-RhodoLED® or RhodoLED® XL work together

AMELUZ® penetrates the epidermis of your skin to reach the premalignant cells that cause AK. It is then converted into the light-activated agent called PpIX. The red light of BF-RhodoLED® or RhodoLED® XL illuminates these cells and activates the agent, setting off a reaction that destroys premalignant cells that cause AK while leaving healthy skin cells mostly intact.1,2,6

Illustration showing how AMELUZ and the RhodoLED XL device work together to treat actinic keratosis (AK). The RhodoLED XL lamp emits red light onto the skin, activating AMELUZ gel that has penetrated into the epidermis. The gel targets and destroys premalignant cells (shown beneath the gel) while leaving healthy skin cells mostly unaffected.

This is a visual representation of AMELUZ® PDT. Graphic is not designed to scale.

How AMELUZ® and BF-RhodoLED® or RhodoLED® XL work together

AMELUZ® penetrates the epidermis of your skin to reach the premalignant cells that cause AK. It is then converted into the light-activated agent called PpIX. The red light of BF-RhodoLED® or RhodoLED® XL illuminates these cells and activates the agent, setting off a reaction that destroys premalignant cells that cause AK while leaving healthy skin cells mostly intact.1,2,6

llustration showing how AMELUZ and the BF-RhodoLED device work together to treat actinic keratosis (AK). The RhodoLED® XL lamp emits red light onto the skin, activating AMELUZ gel that has penetrated into the epidermis. The gel targets and destroys premalignant cells (shown beneath the gel) while leaving healthy skin cells mostly unaffected.

This is a visual representation of AMELUZ® PDT. Graphic is not designed to scale.

Learn more about the treatment process with AMELUZ® and the RhodoLED® lamp series.

HERE'S HOW IT WORKS

Questions

If you have any questions about AMELUZ®, please contact your health care provider.

Learn more about the treatment process with AMELUZ® and RhodoLED® lamp series.

HERE'S HOW IT WORKS

Questions

If you have any questions about AMELUZ®, please contact your health care provider.

Learn more about the treatment process with AMELUZ® and RhodoLED® lamp series.

HERE'S HOW IT WORKS

Questions

If you have any questions about AMELUZ®, please contact your health care provider.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® or RhodoLED® XL lamp, is used for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.

IMPORTANT SAFETY INFORMATION

Purpose: Photosensitizing agent

Uses: AMELUZ®, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® or RhodoLED® XL lamp, is used for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.

Warnings:

Do not use if you have a:

  • Known hypersensitivity to photoactive substances known as porphyrins.
  • Known hypersensitivity to soybeans or to any component of AMELUZ®.

Ask your health care provider before use if you have:

  • Porphyria (hereditary disease that is characterized by abnormal production of a red blood pigment called heme).
  • Photodermatoses (skin conditions caused by or made worse by exposure to light or ultraviolet radiation).

When using this product:

  • Allergic Reactions: AMELUZ® may cause allergic reactions before photodynamic therapy. AMELUZ® should be washed off, and suitable treatment started. The allergic reactions can potentially include severe courses like sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating, and loss of consciousness.
  • Transient Amnestic Episodes: Photodynamic therapy may cause transient amnestic episodes (temporary loss of memory). If observed, the therapy must be stopped immediately. If observed after treatment, contact your health care provider.
  • Risk of BF-RhodoLED® or RhodoLED® XL Lamp–Induced Eye Injury: Patients and health care providers must wear protective eyewear while operating BF-RhodoLED® or RhodoLED® XL.
  • Ophthalmic Adverse Reactions: Avoid applying AMELUZ® into the eyes. Wash eyes with water in case of accidental contact.
  • Increased Photosensitivity: Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment.
  • Risk of Bleeding in Patients With Coagulation Disorders: Special care should be taken to avoid bleeding during lesion preparation in these patients. Bleeding must be stopped before application of the gel.
  • Mucous Membrane Irritation: Avoid direct contact of AMELUZ® with the mucous membranes. Wash with water in case of accidental contact.
  • Concomitant Use of the Following Medications: May increase the intensity of adverse reactions after light exposure related to photodynamic therapy: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines.

Most common side effects at the application site are:

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

Most side effects occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases they persisted for 1 to 2 weeks or even longer.

Pregnancy Warning: There is no available data on AMELUZ® use in pregnant women to inform a drug associated risk.

Lactation Warning: There is no available data regarding the presence of the active ingredient (aminolevulinic acid hydrochloride) in human milk, or the effects of aminolevulinic acid hydrochloride on the breastfed infant or on milk production.

Pediatric Warning: Safety and effectiveness in patients below the age of 18 has not been established.

Geriatric Warning: No overall differences in safety or effectiveness were observed between older (65 years and older) and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Directions:

  • AMELUZ® is administered only by a health care provider.
  • AMELUZ® is for topical use only.
  • Photodynamic therapy with AMELUZ® involves preparation of lesions, application of the product, occlusion and red light illumination with BF-RhodoLED® or RhodoLED® XL. No more than 6 grams of AMELUZ® should be used at one time.
  • Retreat lesions that have not completely resolved 3 months after the initial treatment.

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

  • Store in a refrigerator, 2°C – 8°C (36°F – 46°F). Excursions permitted to 15°C – 30°C (59°F – 86°F).
  • The risk information provided here is not comprehensive. To learn more, talk about AMELUZ® with your health care provider. The FDA-approved product labeling can be found at https://us.ameluz.com/pi.
  • You are encouraged to report side effects of AMELUZ®. Please contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or visit www.fda.gov/medwatch.

References: 1. Reinhold U. A review of BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis. Future Oncol. 2017;13(27):2413-2428. 2. AMELUZ [prescribing information]. Woburn, MA: Biofrontera Inc; 2024. 3. Benov, L. Photodynamic therapy: current status and future directions. Med Princ Pract. 2015;24(Suppl 1):14-28. 4. Agostinis P, Berg K, Cengel KA, et al. Photodynamic therapy of cancer: an update. CA Cancer J Clin. 2011;61(4):250-281. 5. Peng Q, Warloe T, Berg K, et al. 5-Aminolevulinic acid-based photodynamic therapy. Clinical research and future challenges. Cancer. 1997;79(12):2282-2308. 6. Maisch T, Santarelli F, Schreml S, et al. Fluorescence induction of protoporphyrin IX by a new 5-aminolevulinic acid nanoemulsion used for photodynamic therapy in a full-thickness ex vivo model. Exp Dermatol. 2010;19(8):e302-305.