(N=55)
of patients were 100% cleared after 12 weeks2,3,†
(12 weeks after the last treatment) (N=32)
of patients achieved 100% clearance with placebo2,3,†
of patients who were cleared after 12 weeks remained completely clear from all AK one year after the last PDT (n=50)1
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.
AMELUZ® is used in a process called photodynamic therapy (PDT) and uses red light from a lamp called BF‑RhodoLED® to treat visible, mild-to-moderate actinic keratosis lesions on the face and scalp1 and address those hidden below the surface.2
AMELUZ® is a specially formulated gel designed to improve skin penetration and deliver the active ingredient. Within the cells this ingredient is converted into a light-activated agent. When illuminated with the red light of BF‑RhodoLED®, it creates a safe and effective therapy to destroy the premalignant cells that cause AK.1,4-6
BF‑RhodoLED® is an LED lamp that emits a deep-penetrating red light that activates the agent converted from the active ingredient of AMELUZ®.1,5,7
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® illuminates these cells and activates the agent, setting off a reaction that destroys the premalignant cells that cause AK—while leaving healthy skin cells mostly intact.1,2,4,5
If you have any questions about AMELUZ®, we would like to hear from you!
Call us at 1‑844‑4AMELUZ (1‑844‑426‑3589)
Or email us at info‑us@biofrontera.com
(N=55)
of patients were 100% cleared after 12 weeks2,3,†
(12 weeks after the last treatment) (N=32)
of patients achieved 100% clearance with placebo2,3,†
of patients who were cleared after 12 weeks remained completely clear from all AK one year after the last PDT (n=50)1
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.
AMELUZ® is used in a process called photodynamic therapy (PDT) and uses red light from a lamp called BF‑RhodoLED® to treat visible, mild-to-moderate actinic keratosis lesions on the face and scalp1 and address those hidden below the surface.2
AMELUZ® is a specially formulated gel designed to improve skin penetration and deliver the active ingredient. Within the cells this ingredient is converted into a light-activated agent. When illuminated with the red light of BF‑RhodoLED®, it creates a safe and effective therapy to destroy the premalignant cells that cause AK.1,4-6
BF‑RhodoLED® is an LED lamp that emits a deep-penetrating red light that activates the agent converted from the active ingredient of AMELUZ®.1,5,7
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® illuminates these cells and activates the agent, setting off a reaction that destroys the premalignant cells that cause AK—while leaving healthy skin cells mostly intact.1,2,4,5
If you have any questions about AMELUZ®, we would like to hear from you!
Call us at 1‑844‑4AMELUZ (1‑844‑426‑3589)
Or email us at info‑us@biofrontera.com
(N=55)
of patients were 100% cleared after 12 weeks2,3,†
(12 weeks after the last treatment) (N=32)
of patients achieved 100% clearance with placebo2,3,†
of patients who were cleared after 12 weeks remained completely clear from all AK one year after the last PDT (n=50)1
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.
AMELUZ® is used in a process called photodynamic therapy (PDT) and uses red light from a lamp called BF‑RhodoLED® to treat visible, mild-to-moderate actinic keratosis lesions on the face and scalp1 and address those hidden below the surface.2
AMELUZ® is a specially formulated gel designed to improve skin penetration and deliver the active ingredient. Within the cells this ingredient is converted into a light-activated agent. When illuminated with the red light of BF‑RhodoLED®, it creates a safe and effective therapy to destroy the premalignant cells that cause AK.1,4-6
BF‑RhodoLED® is an LED lamp that emits a deep-penetrating red light that activates the agent converted from the active ingredient of AMELUZ®.1,5,7
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® illuminates these cells and activates the agent, setting off a reaction that destroys the premalignant cells that cause AK—while leaving healthy skin cells mostly intact.1,2,4,5
If you have any questions about AMELUZ®, we would like to hear from you!
Call us at 1‑844‑4AMELUZ (1‑844‑426‑3589)
Or email us at info‑us@biofrontera.com
INDICATION
AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
IMPORTANT SAFETY INFORMATION
AMELUZ® (aminolevulinic acid hydrochloride), topical gel, 10%
Purpose: Photosensitizing agent
Uses: AMELUZ® gel, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® 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:
Ask your Health Care Provider before use If you have:
When using this product:
Most common side effects at the application site were:
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 pediatric 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:
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.
Other Information:
References: 1. AMELUZ [prescribing information]. Woburn, MA: Biofrontera Inc; 2021. 2. 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. 3. Reinhold U, Dirschka T, Ostendorf R, et al. A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp. Br J Dermatol. 2016;175(4):696-705. 4. 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 skin model. Exp Dermatol. 2010;19(8):e302-305. 5. Agostinis P, Berg K, Cengel KA, et al. Photodynamic therapy of cancer: an update. CA Cancer J Clin. 2011;61(4):250-281. 6. Wu Y, Li YH, Gao XH, et al. The application of nanoemulsion in dermatology: an overview. J Drug Target. 2013;21(4):321-327. 7. 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.