ameluz
Ameluz (Aminolevulinic Acid Hydrochloride) is an optical imaging agent used to treat Actinic Keratosis.
Aminolevulinic Acid Hydrochloride · by Biofrontera
Key facts
- Active ingredient
- Aminolevulinic Acid Hydrochloride
- Drug class
- Optical Imaging Agent
- Form
- Topical
- Strength
- Aminolevulinic Acid Hydrochloride 10%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- actinic keratosis
- Manufacturer
- Biofrontera
- FDA application
- NDA208081
What is Ameluz?
From the FDA label:11. DESCRIPTION AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion. Aminolevulinic acid, a porphyrin precursor, is a white to off-white crystalline solid. It is readily soluble in water, methanol, and dimethylformamide. Its chemical name is 5-amino-4-oxo-pentanoic acid hydrochloride, molecular weight is 167.59 and molecular formula is C 5 H 9 NO 3 ·HCl. The structural formula of aminolevulinic acid hydrochloride is represented below: Each gram of AMELUZ contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg aminolevulinic acid) as the active ingredient and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, sodium benzoate and purified water. ALA.HCl - Structural Formula
How to use
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…
Side effects
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…
Warnings
Important safety information
Hypersensitivity: Hypersensitivity reactions have been reported with the use of AMELUZ prior to photodynamic therapy (PDT). If allergic reaction occurs, wash off AMELUZ and institute appropriate therapy ( 5.1 ). Transient Amnestic Episodes: Transient amnestic episodes have been reported with use of AMELUZ in combination with PDT. Advise patients to contact their healthcare provider if amnesia or confusion occurs after treatment ( 5.2 ). Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury: Patients and healthcare providers must wear protective eyewear before operating BF-RhodoLED or RhodoLED XL lamp ( 5.3 ). Ophthalmic Adverse Reactions: Avoid direct contact of AMELUZ with the eyes ( 5.4 ). Increased Photosensitivity: Protect treated lesions from sunlight exposure for 48 hours post treatment ( 5.5 ). Risk of Bleeding in Patients with Coagulation Disorders: Take special care to avoid bleeding during lesion preparation in patients with inherited or acquired coagulation disorders ( 5.6 ). Mucous Membrane Irritation: Avoid direct contact of AMELUZ with the mucous membranes ( 5.7 ). 5.1 Hypersensitivity Several cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [ see Adverse Reactions (6.2) ]. If allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe courses (anaphylaxis). 5.2 Transient Amnestic Episodes Transient amnestic episodes have been reported during postmarketing use of AMELUZ in combination with photodynamic therapy. Inform patients and their caregivers that AMELUZ in combination with photodynamic therapy may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment. 5.3 Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury BF-RhodoLED or RhodoLED XL lamp may cause eye irritation, glare, or injury. Before operating the lamp, personnel must refer to the user manual for specific warnings, cautions, and instructions. Eye exposure to the BF-RhodoLED or RhodoLED XL light must be prevented. Protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Avoid staring directly into the light source. 5.4 Ophthalmic Adverse Reactions Eyelid edema and dry eyes have occurred after PDT with AMELUZ. PDT with AMELUZ can cause ophthalmic adverse reactions. Avoid direct contact of AMELUZ with the eyes. Rinse eyes with water in case of accidental contact. 5.5 Increased Photosensitivity AMELUZ increases photosensitivity. Avoid sunlight, prolonged or intense light (e.g., tanning beds, sun lamps) on lesions and surrounding skin treated with AMELUZ for approximately 48 hours following treatment, whether exposed to illumination or not. Concomitant use of AMELUZ with other known photosensitizing agents may increase the risk of phototoxic reaction to PDT [see Drug Interactions (7) ] . 5.6 Risk of Bleeding in Patients with Coagulation Disorders AMELUZ has not been tested on patients with inherited or acquired coagulation disorders. Take special care to avoid bleeding during lesion preparation in such patients [ see Dosage and Administration (2.3) ] . Any bleeding must be stopped before application of the gel. 5.7 Risk of Mucous Membrane Irritation AMELUZ can cause mucous membrane irritation. AMELUZ is intended for topical use only. Avoid direct contact of AMELUZ to the mucous membranes. Rinse with water in case of accidental contact.
Who should not take Ameluz
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 ).
Interactions
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 ).
Drug class
May treat (source: NIH RxClass)
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Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Ameluz treat?
- Ameluz (Aminolevulinic Acid Hydrochloride) may be used to treat actinic keratosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Ameluz?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ameluz. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ameluz?
- Ameluz is marketed by Biofrontera. You can see Biofrontera's full profile, rating, and other products on pharmaranks.
- Is Ameluz a brand-name or generic drug?
- Ameluz is a brand-name product with the active ingredient Aminolevulinic Acid Hydrochloride.
- Is Ameluz available over the counter?
- No. Ameluz is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ameluz come in?
- Ameluz is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Ameluz?
- Ameluz is classified as optical imaging agent, porphyrin precursor, per the FDA's Established Pharmacologic Class.
- Is Ameluz FDA-registered?
- Ameluz is on record with the U.S. FDA under application number NDA208081. You can verify this on its official FDA label.
- Is Ameluz safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ameluz. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ameluz?
- Ameluz's side effects are taken directly from its FDA label. From the label: 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) ] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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