AMELUZ Gel (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Biofrontera Inc.

Λέξεις κλειδιά

70621-101

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1. Indications and Usage

AMELUZ gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic ...

2. Dosage and Administration

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, ...

3. Dosage Forms and Strengths

Each gram of AMELUZ gel, 10% contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid).

4. Contraindications

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 ...

5. Warnings and Precautions

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 ...

6. Adverse Reactions

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 ...

6.1. Clinical Trials 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 ...

6.2. Postmarketing Experience

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 ...

7. Drug 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. Johns wort, griseofulvin, thiazide ...

8.1. Pregnancy

Risk Summary There are no available data on AMELUZ use in pregnant women to inform a drug associated risk. Animal reproduction studies were not conducted with aminolevulinic acid. Systemic absorption of ...

8.2. Lactation

Risk Summary No data are available regarding the presence of aminolevulinic acid in human milk, the effects of aminolevulinic acid on the breastfed infant or on milk production. However, breastfeeding ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established. AK is not a condition generally seen in the pediatric population.

8.5. Geriatric Use

Of the 384 subjects exposed to AMELUZ in randomized, multicenter clinical trials, 83% (318/384) of the subjects were 65 years old and over. No overall differences in safety or effectiveness were observed ...

11. Description

AMELUZ (aminolevulinic acid hydrochloride) gel, 10% for topical use is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion. Aminolevulinic acid, a porphyrin precursor, is ...

12.1. Mechanism of Action

Photoactivation following topical application of AMELUZ occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When ...

12.2. Pharmacodynamics

The pharmacodynamics of AMELUZ in the treatment of actinic keratosis are unknown.

12.3. Pharmacokinetics

Pharmacokinetics (PK) of aminolevulinic acid and PpIX was evaluated in a trial of 12 adult subjects with mild to moderate AK with at least 10 AK lesions on the face or forehead. A single dose of one entire ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of AMELUZ or aminolevulinic acid have not been performed. Aminolevulinic acid revealed no evidence of mutagenic or clastogenic potential based on ...

14. Clinical Studies

The efficacy and safety of AMELUZ in combination with PDT using a narrow spectrum (red light lamp) source were evaluated in three randomized, multicenter trials (Trials 1, 2, and 3). Trials 2 and 3 were ...

16.1. How Supplied

AMELUZ (aminolevulinic acid hydrochloride) gel, 10% is a white-to-yellowish gel. The drug product is supplied in an aluminum tube with a white, high density polyethylene (HDPE) screw cap. Each tube contains ...

16.2. Storage and Handling

Store AMELUZ in a refrigerator, 2°C–8°C (36°F–46°F). Excursions permitted to 15°C–30°C (59°F–86°F). After opening, AMELUZ can be stored for up to 12 weeks in a refrigerator at 2°C–8°C (36°F–46°F) if the ...

17. Patient Counseling Information

Inform patients of the following: Hypersensitivity: Hypersensitivity has been reported with use of AMELUZ. Inform patients and their caregivers that AMELUZ may cause hypersensitivity potentially ...