Treatment Considerations
Dosage and Administration
Levulan® PDT is a 2-part treatment2
Part 1:
Levulan® Kerastick® Topical Solution, 20%, should be applied directly to target lesions by dabbing gently with the wet applicator tip of the Levulan® Kerastick®.
Part 2:
At the visit for light illumination, the lesions that were treated and incubated with Levulan® Kerastick® Topical Solution, 20%, are illuminated with the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes, 40 seconds) exposure is required to provide a 10 J/cm2 light dose.
Patient Management
Managing patient expectations is an important part of the therapeutic process
Patients treated with Levulan PDT should be informed that:
• During the light treatment, patients may experience sensations of tingling, stinging, prickling or burning of the treated AK lesions.2
• These feelings of discomfort should improve at the end of the BLU-U treatment and should subside between 1 minute and 24 hours after the BLU-U is turned off.2
• Following treatment, the treated AKs and to some degree the surrounding skin may redden, and swelling and scaling may also occur. However these effects are temporary and should completely resolve by 4 weeks after treatment.2
• In two phase III trials, severe stinging and/or burning at one or more of the AKs being treated was reported by at least 50% of the patients at some time during treatment.2 Less than 3% of patients discontinued light treatment due to stinging or burning.2
Application of Levulan Kerastick should involve either scalp or face lesions, but not both simultaneously. Levulan Kerastick should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces. Excessive irritation may be experienced if this product is applied under occlusion.
Important Safety Information
Levulan® Kerastick® plus blue light illumination using the BLU-U® blue light photodynamic therapy illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2) of the face or scalp.
Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the Levulan Kerastick for Topical Solution.
Levulan® Kerastick® has not been tested on patients with inherited or acquired coagulation defects. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with the Levulan® Kerastick®.
Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light prior to blue light treatment. Exposure may result in a stinging and/or burning sensation and may cause erythema or edema of the lesions. Patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light.
Transient local symptoms of stinging and/or burning, itching, erythema, and edema were observed in all clinical studies. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during treatment. However, less than 3% of patients discontinued light treatment due to stinging and/or burning.
During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U operating instructions to minimize ocular exposure.
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