AMELUZ

Aminolevulinic acid acts as a prodrug to the photoactive metabolite protoporphyrin IX (PpIX). Pharmacokinetics (PK) of aminolevulinic acid and PpIX were evaluated in two trials: In the first trial, a single dose of one entire tube of AMELUZ (2 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 20 cm 2 in 12 adult subjects with mild to moderate AK with at least 10 AK lesions on the face or forehead. The mean ± SD baseline plasma aminolevulinic acid concentration was...

The efficacy and safety of AMELUZ in combination with PDT using a narrow spectrum (red light lamp) source were evaluated in three randomized, multicenter trials (Trials 1, 2, and 3). Trials 2 and 3 were vehicle-controlled and double-blind. Trial 1 was double-blind with respect to vehicle and observer-blind regarding the active comparator arm. All clinical trials included a follow-up assessment after 6 and 12 months. In these trials, 212 subjects with 4 to 8 mild to moderate AK lesions on the face/forehead and/or bald scalp were treated with up to one tube (2 grams) of AMELUZ on an application ...

The following adverse reactions are discussed in greater detail in other sections of the labeling: ​ Hypersensitivity [see Warnings and Precautions (5.1) ]. Transient Amnestic Episodes [see Warnings and Precautions (5.2) ] . Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury [see Warnings and Precautions (5.3) ] . Ophthalmic Adverse Reactions [see Warnings and Precautions (5.4) ]. Increased Photosensitivity [see Warnings and Precautions (5.5) ] . Most common adverse reactions (≥10%) we...

AMELUZ is contraindicated in patients with: Known hypersensitivity to porphyrins. Known hypersensitivity to any of the components of AMELUZ, which includes soybean phosphatidylcholine [see Warnings and Precautions (5.1) ] . Porphyria. AMELUZ use may cause uncontrolled phototoxic effects [see Warnings and Precautions (5.5) ] . Photodermatoses. PDT may worsen the phototoxic or photoallergic reaction...

Hypersensitivity: Hypersensitivity reactions have been reported with the use of AMELUZ prior to photodynamic therapy (PDT). If allergic reaction occurs, wash off AMELUZ and institute appropriate therapy ( 5.1 ). Transient Amnestic Episodes: Transient amnestic episodes have been reported with use of AMELUZ in combination with PDT. Advise patients to contact their healthcare provider if amnesia or confusion occurs after treatment ( 5.2 ). Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury:...

7. DRUG INTERACTIONS There have been no formal studies of the interaction of AMELUZ with other drugs. It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to PDT [see Warnings and Precautions (5.3) ] . Concom...