For: Actinic Keratosis
Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp. AMELUZ (aminolevulinic acid hydrochloride) gel, 10% is a white-to-yellowish gel. The drug product is supplied in an aluminum tube with a white, high density polyethylene (HDPE) screw cap. Each tube contains 2 g of gel.
NDC 70621-101-01 2 g tube
NDC 70621-101-01 Cardbox containing one 2g tube
NDC 70621-101-10 Cardbox containing one 2g tube
Store AMELUZ in a refrigerator, 2�C � 8�C (36�F � 46�F). Excursions permitted to 15�C � 30�C (59�F � 86�F).
After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2�C � 8�C (36�F � 46�F) if the tube is tightly closed. These highlights do not include all the information needed to use AMELUZ safely and effectively. See full prescribing information for AMELUZ.
AMELUZ� (aminolevulinic acid hydrochloride) gel, 10%, for topical use
Initial U.S. Approval: 1999
INDICATIONS AND USAGE
AMELUZ gel, 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 (1).
DOSAGE AND ADMINISTRATION
Administer AMELUZ only by a health care provider (2.1).
AMELUZ is for topical use only (2.1).
Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED (2.2).
Retreat lesions that have not completely resolved 3 months after the initial treatment (2.1).
See BF-RhodoLED user manual for detailed lamp safety and operating instructions (2.1).
DOSAGE FORMS AND STRENGTHS
Gel: 10% (3).
CONTRAINDICATIONS
Known hypersensitivity to porphyrins (4).
Known hypersensitivity to any component of AMELUZ, which includes soybean phosphatidylcholine (4).
Porphyria (4).
Photodermatoses (4).
WARNINGS AND PRECAUTIONS
Transient Amnestic Episodes have been reported with use of AMELUZ in combination with photodynamic therapy (PDT). If patients experience amnesia or confusion, discontinue treatment and contact Healthcare Provider (5.1).
Risk of Eye Injury: Patients and healthcare providers must wear protective eyewear before operating BF-RhodoLED lamp (5.2).
Photosensitivity: Protect treated lesions from sunlight exposure for 48 hours post treatment (5.3).
Risk of Bleeding: Special care should be taken to avoid bleeding during lesion preparation in patients with inherited or acquired coagulation disorders (5.4).
Ophthalmic Adverse Reactions: Avoid direct contact of AMELUZ with the eyes (5.5).
Mucous Membrane Irritation: Avoid direct contact of AMELUZ with the mucous membranes (5.6).
ADVERSE REACTIONS
Most common adverse reactions (?10%) were application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Concomitant use of the following medications may enhance the phototoxic reaction to photodynamic therapy: St. John�s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines (7).
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2019
