Actinic keratoses are premalignant lesions of the skin that, when left untreated, can potentially develop into squamous cell carcinoma (SCC), the second most common form of skin cancer. AK is primarily caused by chronic sun damage and generally affect people aged 40 or older.1
AK lesions typically form on areas of the body most exposed to the sun—such as the face, scalp, neck, and ears. Different types of AK lesions can have a different clinical appearance. AK lesions on the surface of the skin are frequently scaly, range from normal skin color to reddish brown, and can be identified by sight and/or touch. Because AK originates in the skin layers below the visible surface, lesions can be present but still hidden from view. These lesions are known as subclinical lesions.1,3
Sun damage is usually spread over a large area where multiple AK lesions can develop over time. For every visible lesion on the surface, there are likely others hidden below. When surface and subclinical lesions cover a particular area, they form a premalignant field.2,3
For every AK lesion you can see, there are more you can’t.3
It’s not uncommon for subclinical AK lesions to progress to iSCC.6 Potential progression risk reported as being between 0.025% and 16%.7
If you have any questions about AMELUZ® (aminolevulinic acid HCI) topical gel, 10%, 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
Actinic keratoses are premalignant lesions of the skin that, when left untreated, can potentially develop into squamous cell carcinoma (SCC), the second most common form of skin cancer. AK is primarily caused by chronic sun damage and generally affect people aged 40 or older.1
AK lesions typically form on areas of the body most exposed to the sun—such as the face, scalp, neck, and ears. Different types of AK lesions can have a different clinical appearance. AK lesions on the surface of the skin are frequently scaly, range from normal skin color to reddish brown, and can be identified by sight and/or touch. Because AK originates in the skin layers below the visible surface, lesions can be present but still hidden from view. These lesions are known as subclinical lesions.1,3
Sun damage is usually spread over a large area where multiple AK lesions can develop over time. For every visible lesion on the surface, there are likely others hidden below. When surface and subclinical lesions cover a particular area, they form a premalignant field.2,3
For every AK lesion you can see, there are more you can’t.3
It’s not uncommon for subclinical AK lesions to progress to iSCC.6 Potential progression risk reported as being between 0.025% and 16%.7
If you have any questions about AMELUZ® (aminolevulinic acid HCI) topical gel, 10%, 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
Actinic keratoses are premalignant lesions of the skin that, when left untreated, can potentially develop into squamous cell carcinoma (SCC), the second most common form of skin cancer. AK is primarily caused by chronic sun damage and generally affect people aged 40 or older.1
AK lesions typically form on areas of the body most exposed to the sun—such as the face, scalp, neck, and ears. Different types of AK lesions can have a different clinical appearance. AK lesions on the surface of the skin are frequently scaly, range from normal skin color to reddish brown, and can be identified by sight and/or touch. Because AK originates in the skin layers below the visible surface, lesions can be present but still hidden from view. These lesions are known as subclinical lesions.1,3
Sun damage is usually spread over a large area where multiple AK lesions can develop over time. For every visible lesion on the surface, there are likely others hidden below. When surface and subclinical lesions cover a particular area, they form a premalignant field.2,3
For every AK lesion you can see, there are more you can’t.3
It’s not uncommon for subclinical AK lesions to progress to iSCC.6 Potential progression risk reported as being between 0.025% and 16%.7
If you have any questions about AMELUZ® (aminolevulinic acid HCI) topical gel, 10%, 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. 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. Stockfleth E. The importance of treating the field in actinic keratosis. J Eur Acad Dermatol Venereol. 2017;31(Suppl 2):8-11. 3. Berman B, Amini S, Valins W, Block S. Pharmacotherapy of actinic keratosis. Expert Opin Pharmacother. 2009;10(18):3015-3031. 4. Flohil C, van der Leest R, Dowlatshahi E, Hofman A, de Vries E, Nijsten T. Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol. 2013;133(8):1971-1978. 5. de Berker D, McGregor JM, Mohd Mustapa MF, Exton LS, Hughes BR. British Association of Dermatologists’ guidelines for the care of patients with actinic keratosis 2017. Br J Dermatol. 2017;176(1):20-43. 6. Fernández-Figueras MT, Carrato C, Sáenz X, et al. Actinic keratosis with atypical basal cells (AK I) is the most common lesion associated with invasive squamous cell carcinoma of the skin. J Eur Acad Dermatol Venereol. 2015;29:991-997. 7. Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol Surg. 2007;33(9):1099-1101.