WHEN
DANGER LURKS
BELOW THE SURFACE
WHEN
DANGER LURKS
BELOW THE SURFACE
WHEN
DANGER LURKS
BELOW THE SURFACE
Ask your healthcare provider about PDT with AMELUZ® and BF‑RhodoLED®, the only PDT drug approved to treat visible AK lesions on the face and scalp4 and address subclinical lesions hidden below.2
Do not use if you have a:
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
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. Berman B, Amini S, Valins W, Block S. Pharmacotherapy of actinic keratosis. Expert Opin Pharmacother. 2009;10(18): 3015-3031. 2. Reinhold U. A review at BF-200 ALA for the photodynamic treatment of mild-to-moderate actinic keratosis. Future Oncol. 2017;13(270:2413-2428. 3. AMELUZ [Prescribing information]. Woburn, MA: Biofrontera Inc; 2021.