Aminolevulinic Acid is an optical imaging agent sold in the U.S. under 2 brand and generic names, for actinic keratosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Ameluz (application NDA208081). Other aminolevulinic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer AMELUZ only by a health care provider ( 2.1 ). AMELUZ is for topical use only ( 2.1 ). Use AMELUZ in combination with red light photodynamic therapy (PDT). See BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions ( 2.1 ). Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED or RhodoLED XL lamp ( 2.3 ). Apply an approximately 1 mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm 2 . Do not use more than 6 grams of AMELUZ (3 tubes) at one time ( 2.2 ). Retreat lesions that have not completely resolved 3 months after the initial treatment ( 2.2 ). 2.1 Important Administration Information AMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider. AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use. Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light. Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions. Adhere to all safety…
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%) were application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 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 phase 3 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Topical | — | — | View → | |
| 2 | Not yet rated | Prescription | Kit | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 reactions [see Warnings and Precautions (5.5) ] . Known hypersensitivity to porphyrins ( 4 ). Known hypersensitivity to any component of AMELUZ, which includes soybean phosphatidylcholine ( 4 ). Porphyria ( 4 ). Photodermatoses ( 4 ).
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) ] . Concomitant use of the following medications may enhance the phototoxic reaction to photodynamic therapy: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines ( 7 ).