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Pronunciation:

(a MEE noh lev yoo lin ik AS id)

U.S. Brand Names:

Levulan® Kerastick®

Synonyms:

Aminolevulinic Acid Hydrochloride

Generic Available:

Canadian Brand Names:

Levulan®

Use:

Treatment of minimally to moderately thick actinic keratoses (grade 1 or 2) of the face or scalp; to be used in conjunction with blue light illumination

Pregnancy Risk Factor:

Pregnancy Implications:

Animal reproduction studies have not been conducted, and there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to aminolevulinic acid or any component of the formulation; individuals with cutaneous photosensitivity at wavelengths of 400-450 nm; porphyria; allergy to porphyrins

Warnings/Precautions:

For external use only. Do not apply to eyes or mucous membranes. Treatment site will become photosensitive following application. Patients should be instructed to avoid exposure to sunlight, bright indoor lights, or tanning beds during the period prior to blue light treatment. Should be applied by a qualified health professional to avoid application to perilesional skin. Has not been tested in individuals with coagulation defects (acquired or inherited).

Adverse Reactions:

Transient stinging, burning, itching, erythema, and edema result from the photosensitizing properties of this agent. Symptoms subside between 1 minute and 24 hours after turning off the blue light illuminator. Severe stinging or burning was reported in at least 50% of patients from at least 1 lesional site treatment.

>10%: Dermatologic: Severe stinging or burning (50%), scaling of the skin/crusted skin (64% to 71%), hyperpigmentation/hypopigmentation (22% to 36%), itching (14% to 25%), erosion (2% to 14%)

1% to 10%:

Central nervous system: Dysesthesia (up to 2%)

Dermatologic: Skin ulceration (2% to 4%), vesiculation (4% to 5%), pustular drug eruption (up to 4%), skin disorder (5% to 12%)

Hematologic: Bleeding/hemorrhage (2% to 4%)

Local: Wheal/flare (2% to 7%), local pain (1%), tenderness (1% to 2%), edema (1%), scabbing (up to 2%), ulceration (2% to 4%), excoriation (1%)

Overdosage/Toxicology:

Monitoring and supportive care are recommended. Patient should be advised to avoid incidental exposure to intense light sources for at least 40 hours. The consequences of exceeding the recommended topical dosage are not known.

Drug Interactions:

Photosensitizing agents including griseofulvin, thiazide diuretics, sulfonamides, sulfonylureas, phenothiazines, and tetracyclines theoretically may increase the photosensitizing potential of aminolevulinic acid

Stability:

Store at 25°C (77°F). Prepare solution by holding applicator tube with cap pointing up. Apply finger pressure to "Position A" on cardboard sleeve to crush ampul containing solution vehicle. Apply finger pressure to "Position B" to crush ampul containing aminolevulinic acid powder. Shake gently for at least 3 minutes to dissolve; point applicator cap away from face while shaking tube. Remove cap; dab dry applicator tip on gauze pad until wet with solution. Once prepared, the topical solution should be used immediately and application must be completed within 2 hours.

Mechanism of Action:

Aminolevulinic acid is a metabolic precursor of protoporphyrin IX (PpIX), which is a photosensitizer. Photosensitization following application of aminolevulinic acid topical solution occurs through the metabolic conversion to PpIX. When exposed to light of appropriate wavelength and energy, accumulated PpIX produces a photodynamic reaction.

Pharmacodynamics/Kinetics:

PpIX:

Peak fluorescence intensity: 11 hours ± 1 hour

Half-life, mean clearance for lesions: 30 ± 10 hours

Dosage:

Adults: Topical: Apply to actinic keratoses (not perilesional skin) followed 14-18 hours later by blue light illumination. Application/treatment may be repeated at a treatment site after 8 weeks.

Administration:

Dab lesion gently with wet applicator tip. Do not apply to periorbital area, ocular tissue, or mucosal surfaces. Allow to dry then reapply to same lesion. Apply to either scalp or facial lesions, but not to both simultaneously. Follow application with blue light exposure in 14-18 hours.

Patient Education:

This medication is for external use only; do not allow any solution to contact eyes, mouth, or nasal membranes. Follow exact directions for application (see below). You may experience stinging, burning, itching, swelling, or pain after turning off blue light illuminator. If these or any other adverse skin effects last longer than 24 hours, notify prescriber. Report immediately any indications of unusual bleeding or bruising. Solution should be used immediately following preparation of solution according to directions. Apply to clean, dry skin with applicator, directly to lesions. Blue light exposure should follow between 14-18 hours after the application. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Additional Information:

Use in conjunction with the BLU-U™ Blue Light Photodynamic Therapy Illuminator.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Bleeding/hemorrhage.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Powder for topical solution: 20% (1s, 6s) [2-component system containing aminolevulinic acid hydrochloride 354 mg (powder) and diluent containing ethanol 48% (1.5 mL) packaged together in an applicator tube]

International Brand Names:

Levulan® (CA)

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