Ameluz Generic Name & Formulations
Aminolevulinic acid HCl 10%; gel; contains isopropyl alcohol, soybean phosphatidylcholine.
In combination with photodynamic therapy (PDT) using BF-RhodoLED lamp (red light illumination source), for the treatment of mild to moderate actinic keratoses on the face and scalp.
Ameluz Dosage and Administration
Clean and prepare all lesions prior to application. Apply gel approx. 1mm thick and include approx. 5mm of the surrounding skin. Use sufficient amount of gel to cover lesion(s) and entire area. Max application area of 20cm2 and max 2g (1 tube) use at one time. Cover treated area with occlusive dressing for 3 hours, then remove dressing and any remaining gel; immediately following illumination with red light: see full labeling. Treated lesions not completely resolved after 12 weeks may be retreated.
<18yrs: not established.
Porphyrin hypersensitivity. Porphyria. Photodermatoses.
Ameluz Boxed Warnings
Administered by healthcare provider only. Hypersensitivity reactions including anaphylaxis; treat appropriately if occur. In combination with PDT may cause transient amnestic episodes. Not for ophthalmic, oral, or intravaginal use. Avoid sunlight, prolonged, or intense light (eg, tanning beds, sunlamps) on lesions and surrounding skin for 2 days after treatment. Avoid applying to eyes, mucous membranes. Inherited or acquired coagulation disorders; avoid bleeding during lesion preparation. Pregnancy. Nursing mothers.
May increase risk of phototoxic reaction to PDT with concomitant other photosensitizing agents (eg, St. John's wort, griseofulvin, thiazides, sulfonylureas, phenothiazines, sulfonamides, quinolones, tetracyclines).
Ameluz Adverse Reactions
Application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, vesicles, paresthesia, hyperalgesia; hypersensitivity reactions, ophthalmic reactions, increased photosensitivity.
Ameluz Clinical Trials
Ameluz Patient Counseling