Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

LEVULAN KERASTICK and BLU-U® Blue Light Treatment Administration

LEVULAN KERASTICK for Topical Solution 20% is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. This product is not intended for application by patients or unqualified medical personnel. Application should involve either scalp or face lesions, but not both simultaneously.

The recommended treatment frequency is: one application of the LEVULAN KERASTICK Topical Solution and one dose of illumination per treatment site per 8-week treatment session. Each individual LEVULAN KERASTICK for Topical Solution should be used for only one patient.

Photodynamic therapy for actinic keratoses with LEVULAN KERASTICK for Topical Solution is a two stage process involving:

a) application of the product to the target lesions with LEVULAN KERASTICK Topical Solution, followed 14 to 18 hours later by
b) illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator. The second visit, for illumination, must take place in the 14-18 hour window following application. Patients in clinical trials usually received application in the late afternoon, with illumination the following morning. Treated lesions that have not completely resolved after 8 weeks may be treated a second time with LEVULAN KERASTICK for Topical Solution Photodynamic Therapy.

Step A - LEVULAN KERASTICK for Topical Solution Application

Preparation of lesions

Actinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution.

Preparation of LEVULAN KERASTICK

LEVULAN KERASTICK can be prepared either manually, or using the optional Kerastick Krusher. (See LEVULAN KERASTICK preparation)

Application of solution

1. Following solution admixture, remove the cap from the LEVULAN KERASTICK Topical Solution.

2. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution.

3. Apply the solution directly to the target lesions by dabbing gently with the wet applicator tip. Enough solution should be applied to uniformly wet the lesion surface, including the edges without excess running or dripping.

a. The effect of LEVULAN KERASTICK Topical Solution on ocular tissues is unknown.
b. LEVULAN KERASTICK Topical Solution should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces.

4. Once the initial application has dried, apply again in the same manner.

a. The LEVULAN KERASTICK Topical Solution must be used immediately following preparation (dissolution) due to the instability of the activated product.
b. If the solution application is not completed within 2 hours of activation, the applicator should be discarded and a new LEVULAN KERASTICK for Topical Solution used.

5. Photosensitization of the treated lesions will take place over the next 14-18 hours.

a. The actinic keratoses should not be washed during this time.
b. The patient should be advised to wear a wide-brimmed hat or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK Topical Solution.
c. Sunscreens will not protect against photosensitivity reactions caused by visible light during this time.
d. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.
e. If for any reason the patient cannot be given BLU-U treatment during the prescribed time after LEVULAN KERASTICK Topical Solution application, he or she may nonetheless experience sensations of stinging and/or burning if the photosensitized actinic keratoses are exposed to sunlight or prolonged or intense light at that time.

Step B - Administration of BLU-U Treatment 14 to 18 hours after application

LEVULAN KERASTICK for Topical Solution is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK Topical Solution without subsequent BLU-U illumination is not recommended.

1. At the visit for light illumination, the actinic keratoses to be treated should be gently rinsed with water and patted dry.

2. Photoactivation of actinic keratoses treated with LEVULAN KERASTICK Topical Solution is accomplished with BLU-U illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator.

3. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm2 light dose.

4. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Operating Instructions.

a. Please refer to the BLU-U Operating Instructions for further information on conducting the light treatment.
b. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure.
c. If blue light treatment with the BLU-U Blue Light Photodynamic Therapy Illuminator is interrupted or stopped for any reason, it should not be restarted and the patient should be advised to protect the treated lesions from exposure to sunlight or prolonged or intense light for at least 40 hours after application of the LEVULAN KERASTICK Topical Solution.

5. After light treatment, the patient should be advised to wear a wide-brimmed hat or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK Topical Solution.

a. Sunscreens will not protect against photosensitivity reactions caused by visible light during this time.
b. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

For patients with facial lesions:

1. The BLU-U Blue Light Photodynamic Therapy Illuminator is positioned so that the base is slightly above the patient’s shoulder, parallel to the patient’s face.

2. The BLU-U is positioned around the patient’s head so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface:

a) The patient’s nose should be no closer than 2” from the surface;
b) The patient’s forehead and cheeks should be no further than 4” from the surface;
c) The sides of the patient’s face and the patient’s ears should be no closer than 2” from the BLU-U surface.

For patients with scalp lesions:

1. The knobs on either side of the BLU-U are loosened and the BLU-U is rotated to a horizontal position.

2. The BLU-U is positioned around the patient’s head so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface:

a) The patient’s scalp should be no closer than 2” from the surface;
b) The patient’s scalp should be no further than 4” from the surface;
c) The sides of the patient’s face and the patient’s ears should be no closer than 2” from the BLU-U surface.

 

Please refer to the Full Prescribing Information for additional information.

 

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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