Actinic keratoses:

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 Dosage:

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 Dosage:

<18yrs: not established.

AMELUZ Contraindications:

Porphyrin hypersensitivity. Porphyria. Photodermatoses.

AMELUZ 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.

AMELUZ Classification:

Photosensitizer.

AMELUZ 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).

Adverse Reactions:

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

Generic Drug Availability:

NO

How Supplied:

Gel—2g

Pricing for AMELUZ

2g of 10% tube of gel (Qty: 1)
Appx. price $300
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