Levulan Kerastick Generic Name & Formulations
Legal Class
Rx
General Description
Aminolevulinic acid HCl 20%; topical soln; contains alcohol.
Pharmacological Class
Photosensitizer.
How Supplied
Single-use applicators—6
Manufacturer
Generic Availability
NO
Levulan Kerastick Indications
Indications
In combination with blue light illumination (BLU-U Blue Light Photodynamic Therapy Illuminator), for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.
Levulan Kerastick Dosage and Administration
Adult
Clean and dry affected area. Apply to lesions on either scalp, face, or upper extremities, but not simultaneously. One application and one dose of illumination per treatment site per 8-week treatment session. Face or scalp: illumination (second stage) must take place 14–18hrs after application. Protect treated lesions from sun with a head covering. Upper extremities: occlude treated lesions with low density polyethylene plastic wrap and net dressing; protect from sun with long-sleeved shirt and/or gloves. Illumination (second stage) must take place 3hrs after application. Delay in illumination: protect treated lesions for ≥40hrs; see full labeling. Treated lesions not completely resolved after 8 weeks may be treated a second time.
Children
<18yrs: not established.
Levulan Kerastick Contraindications
Contraindications
Cutaneous photosensitivity at wavelengths of 400–450nm. Porphyria or known allergies to porphyrins.
Levulan Kerastick Boxed Warnings
Not Applicable
Levulan Kerastick Warnings/Precautions
Warnings/Precautions
Avoid exposure of photosensitive treatment sites to sunlight or bright indoor light for ≥40hrs. Avoid applying to eyes, mucous membranes, perilesional skin (no more than 5mm around target lesions). Excessive irritation if applied under occlusion >3hrs. Inherited or acquired coagulation defects. Pregnancy. Nursing mothers.
Levulan Kerastick Pharmacokinetics
See Literature
Levulan Kerastick Interactions
Interactions
Increased photosensitivity reaction with concomitant photosensitizing agents (eg, griseofulvin, thiazides, sulfonylureas, phenothiazines, sulfonamides, tetracyclines, St. John's wort).
Levulan Kerastick Adverse Reactions
Adverse Reactions
Local reactions (eg, stinging/burning, erythema, edema, scaling/crusting, itching, erosion, hypo-/hyperpigmentation, oozing/vesiculation, dryness); photosensitivity, transient amnestic episodes (monitor).
Levulan Kerastick Clinical Trials
See Literature
Levulan Kerastick Note
Not Applicable
Levulan Kerastick Patient Counseling
See Literature