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Aminolevulinic acid hydrochloride

Brand and Other Names: AMELUZ®
Mechanism of Action:

Photoactivation following topical application of AMELUZ occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells. AMELUZ photodynamic therapy of AK lesions utilizes photoactivation of topically applied AMELUZ resulting from BF-RhodoLED or RhodoLED XL illumination, which provides a red light of narrow spectrum and a light dose of approximately 37 J/cm2.

Indications:

AMELUZ, 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.

Route: Topical
Dose:
  • Administer AMELUZ only by a health care provider. 
  • AMELUZ is for topical use only. 
  • Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED or RhodoLED XL lamp. 
  • Retreat lesions that have not completely resolved 3 months after the initial treatment.
  • See BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions.
Adverse Reactions:
Most common adverse reactions (≥10%) were application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles.
Contraindication:
  • Known hypersensitivity to porphyrins. 
  • Known hypersensitivity to any component of AMELUZ, which includes soybean phosphatidylcholine. 
  • Porphyria. 
  • Photodermatoses.
Warnings and Precautions:
  • Hypersensitivity reactions have been reported with the use of AMELUZ prior to photodynamic therapy (PDT). AMELUZ should be washed off and appropriate therapy instituted.
  • Transient Amnestic Episodes have been reported with use of AMELUZ in combination with PDT. If patients experience amnesia or confusion, discontinue treatment and contact healthcare provider. 
  • Risk of Eye Injury: Patients and healthcare providers must wear protective eyewear before operating BF-RhodoLED or RhodoLED XL lamp.
  • Photosensitivity: Protect treated lesions from sunlight exposure for 48 hours post treatment. 
  • Risk of Bleeding: Special care should be taken to avoid bleeding during lesion preparation in patients with inherited or acquired coagulation disorders. 
  • Ophthalmic Adverse Reactions: Avoid direct contact of AMELUZ with the eyes. 
  • Mucous Membrane Irritation: Avoid direct contact of AMELUZ with the mucous membranes.
See package insert for full prescribing information.