Medical Editor: John P. Cunha, DO, FACOEP
Ameluz (aminolevulinic acid hydrochloride) gel, 10%, for topical use, is a porphyrin precursor, used in combination with photodynamic therapy using BF-RhodoLED lamp, indicated for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. Common side effects of Ameluz include:
- application site reactions
- scaling of skin
- hard lumps
- chills, and
- numbness and tingling
- increased sensitivity to pain
- bleeding, and
Ameluz is administered by a health care provider and they will determine the dose. Ameluz may interact with St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or become pregnant before using Ameluz. Ameluz is not expected to be harmful to a fetus. It is unknown if Ameluz passes into breast milk but it is not expected to be harmful to a nursing infant. Consult your doctor before breastfeeding.
Our Ameluz (aminolevulinic acid hydrochloride) gel, 10%, for topical use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Transient Amnestic Episodes [see WARNINGS AND PRECAUTIONS].
- Risk of BF-RhodoLED Lamp Induced Eye Injury [see WARNINGS AND PRECAUTIONS].
- Increased Photosensitivity [see WARNINGS AND PRECAUTIONS].
- Risk of Bleeding in Patients with Coagulation Disorders [see WARNINGS AND PRECAUTIONS].
- Ophthalmic Adverse Reactions [see WARNINGS AND PRECAUTIONS].
- Risk of Mucous Membrane Irritation [see WARNINGS AND PRECAUTIONS].
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for AMELUZ included three double-blind and placebo-controlled trials (Trials 1, 2, and 3), enrolling a total of 299 subjects that were treated with narrow band light. Trial subjects were adults greater than or equal to 49 years of age, and the majority had Fitzpatrick skin type I, II, or III. No subjects had Fitzpatrick skin type V or VI. Approximately 86% of subjects were male, and all subjects were Caucasian.
For all trials, the enrolled subjects had mild to moderate AKs (Olsen grade 1 and 2) with 4 to 8 lesions on the face and scalp. Overall, 87 placebo-treated subjects (n=16, n=32, n=39) and 212 AMELUZ-treated subjects (n=32, n=55, and n=125) were illuminated with BF-RhodoLED or similar narrow spectrum lamps.
Local skin reactions at the application site were observed in about 99.5% of subjects treated with AMELUZ and narrow spectrum lamps. The most frequent adverse reactions during and after PDT were application site erythema, pain, burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles.
Most adverse reactions occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases, however, they persisted for 1 to 2 weeks or even longer. Severe pain/burning occurred in up to 30% of subjects. In one case, the adverse reactions required interruption or discontinuation of the illumination.
The incidence of common (≥ 1%, <10%) and very common (≥ 10%) adverse reactions in randomized, multicenter trials at the application site are presented in Table 1.
Table 1: Incidence of Adverse Reactions Occurring at
≥ 1% of the AMELUZ Group and More Frequently than the Vehicle Group in the
Actinic Keratosis Trials at the Application Site
|Adverse reactions at the application site|
|Erythema||34 (39%)||195 (92%)|
|Pain/Burning||26 (30%)||195 (92%)|
|Irritation||17 (20%)||153 (72%)|
|Edema||3 (3%)||75 (35%)|
|Pruritus||14 (16%)||72 (34%)|
|Exfoliation||4 (5%)||41 (19%)|
|Scab||2 (2%)||41 (19%)|
|Induration||0 (0%)||26 (12%)|
|Vesicles||1 (1%)||25 (12%)|
|Paresthesia||2 (2%)||18 (9%)|
|Hyperalgesia||0 (0%)||13 (6%)|
|Reaction||2 (2%)||8 (4%)|
|Discomfort||0 (0%)||7 (3%)|
|Erosion||0 (0%)||6 (3%)|
|Discharge||0 (0%)||4 (2%)|
|Bleeding||0 (0%)||3 (1%)|
|Pustules||0 (0%)||3 (1%)|
Common (≥ 1%, <10%) adverse reactions not at the application site for AMELUZ were headache, skin exfoliation, chills and eyelid edema.
Less common (≥ 0.1%, <1%) adverse reactions at the application site for AMELUZ were hemorrhage and swelling. The adverse reactions not at the application site were blister, feeling hot, pruritus, pyrexia, scab, nervousness, pain, petechiae, rash pustular, skin erosion and ulcer.
In a clinical trial designed to investigate the sensitization potential of aminolevulinic acid with 216 healthy subjects, 13 subjects (6%) developed allergic contact dermatitis after continuous exposure for 21 days with doses of aminolevulinic acid that were higher than doses normally used in the treatment of AK.
The following adverse reactions have been reported during post-approval use of AMELUZ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: application site inflammation, application site discoloration.
General disorders and administration site conditions: fatigue.
Nervous system disorders: dysaesthesia, transient amnestic episodes.
Read the entire FDA prescribing information for Ameluz (Aminolevulinic Acid Hydrochloride Gel)