AMELUZ Rx

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AMELUZ

Actinic keratoses
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Generic Name and Formulations:

Aminolevulinic acid HCl 10%; gel; contains isopropyl alcohol.

Company:

Biofrontera Inc.

Select therapeutic use:

Indications for AMELUZ:

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.

Adult:

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.

Children:

<18yrs: not established.

Contraindications:

Porphyrin hypersensitivity. Porphyria. Photodermatoses.

Warnings/Precautions:

Administered by healthcare provider only. 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. Pregnancy. Nursing mothers.

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).

Pharmacological Class:

Photosensitizer.

Adverse Reactions:

Application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, vesicles, paresthesia, hyperalgesia; ophthalmic reactions, increased photosensitivity.

Generic Availability:

NO

How Supplied:

Gel—2g

AMELUZ 2g of 10% tube of gels (Qty:1)

appx. price $289.00