Talk with your healthcare provider about using PDT with AMELUZ® and the red light of BF-RhodoLED® or RhodoLED® XL to treat the threat of mild-to-moderate actinic keratosis (AK) on your face and scalp.1,2
Be prepared for your appointment with your healthcare provider. Make a list of questions and take this handy brochure with you. It will be a good starting point and may help you make the most of your time with your physician.
If you have any questions about AMELUZ®, please contact your healthcare provider.
Talk with your healthcare provider about using PDT with AMELUZ® and the red light of BF-RhodoLED® or RhodoLED® XL to treat the threat of mild-to-moderate actinic keratosis (AK) on your face and scalp.1,2
Be prepared for your appointment with your healthcare provider. Make a list of questions and take this handy brochure with you. It will be a good starting point and may help you make the most of your time with your physician.
If you have any questions about AMELUZ®, please contact your healthcare provider.
Talk with your healthcare provider about using PDT with AMELUZ® and the red light of BF-RhodoLED® or RhodoLED® XL to treat the threat of mild-to-moderate actinic keratosis (AK) on your face and scalp.1,2
Be prepared for your appointment with your healthcare provider. Make a list of questions and take this handy brochure with you. It will be a good starting point and may help you make the most of your time with your physician.
If you have any questions about AMELUZ®, please contact your healthcare provider.
INDICATION
AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® or RhodoLED® XL 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® 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:
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, sodium benzoate and purified water.
Other Information:
References: 1. AMELUZ [prescribing information]. Woburn, MA: Biofrontera Inc: 2024. 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.