Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

Patient Education

Setting and managing patient expectations is an important part of the therapeutic process. To ensure patient acceptance and compliance with LEVULAN KERASTICK and BLU-U® PDT you must clearly communicate to them what they should expect before, during and after therapy. What follows is the step by step process including post treatment expectations.

Before treatment:

  • Provide patient with the patient insert and review potential side effects.
  • Be sure to ask if patients are taking any oral medications or using any topical prescription or non-prescription products on their face or scalp. LEVULAN KERASTICK and BLU-U PDT is 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.
  • On treatment days remind patients to bring a wide-brimmed hat or adequate sun-protective item to shield the treated lesions from sunlight or other forms of bright light.

During treatment:

  • Remind patients to not wash their face in between treatment steps.
  • Remind patients to avoid exposure of the treated lesions to sunlight and other forms of bright light for at least 40 hours. Examples include exam room examination lights, operating room lamps, tanning bed lights, and household lights at close range. Sunscreens will not protect against photosensitivity reactions caused by visible light during this time.
  • Inform patients that they may experience sensations of tingling, stinging (sometimes severe), prickling or burning of the treated AK lesions.
  • Patients and medical personnel must wear blue blocking protective eyewear.

After treatment:

  • Inform patients that they may apply moisturizers as needed.
  • Inform patients that following treatment, their treated AKs and to some degree the surrounding skin may redden.  Swelling, scaling, and itching may also occur.  However, these effects are temporary and should completely resolve by 4 weeks after treatment.

 

For additional information or support, please contact DUSA Medical Affairs at (877) 799-3872.

 

Important Risk 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 of the face or scalp.

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.

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 for at least 40 hours after LEVULAN KERASTICK application. 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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