• Actinic keratoses

Ameluz Generic Name & Formulations

General Description

Aminolevulinic acid HCl 10%; gel; contains isopropyl alcohol, soybean phosphatidylcholine.

Pharmacological Class


How Supplied



Generic Availability


Ameluz Indications


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.

Ameluz Contraindications


Porphyrin hypersensitivity. Porphyria. Photodermatoses.

Ameluz Boxed Warnings

Not Applicable

Ameluz Warnings/Precautions


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.

Ameluz Pharmacokinetics

See Literature

Ameluz Interactions


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

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

See Literature

Ameluz Note

Not Applicable

Ameluz Patient Counseling

See Literature