Levulan Kerastick
(Aminolevulinic Acid Hydrochloride)Dosage & Administration
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Levulan Kerastick Prescribing Information
Indications and Usage ( The LEVULAN KERASTICK for topical solution 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, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities. | 03/2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dosage and Administration (
After mixing, the LEVULAN KERASTICK 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 lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously. The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient. LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.
If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, 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. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced. LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment. Step A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical Solution 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 topical solution The LEVULAN KERASTICK applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains aminolevulinic acid HCl as a dry solid. LEVULAN KERASTICK topical solution is prepared by crushing the glass ampoules and mixing the contents together. The LEVULAN KERASTICK topical solution can be prepared either manually, or using the optional KERASTICK KRUSHER™. These methods are illustrated below. Figure 1: Manual Preparation: 
Figure 2: Optional KERASTICK KRUSHER Preparation: 
The LEVULAN KERASTICK topical solution must be used within two (2) hours of activation. If the solution is not completely applied within 2 hours of the activation, discard the applicator. If needed, use a new LEVULAN KERASTICK applicator. Application of LEVULAN KERASTICK topical solution Application of LEVULAN KERASTICK topical solution to Face or Scalp Lesions: Following solution admixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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. Once the initial application has dried, apply again in the same manner. Do not apply the LEVULAN KERASTICK topical solution to the periorbital area or allow it to contact ocular or mucosal surfaces. Photosensitization of the treated lesions will take place over the next 14-18 hours. The actinic keratoses should not be washed during this time. 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 BLU-U Blue Light Photodynamic Therapy Illuminator treatment. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced. At the visit for light illumination before treatment, the actinic keratoses treated with the LEVULAN KERASTICK topical solution should be gently rinsed with water and patted dry. For Lesions on the Upper Extremities Following solution mixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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. Occlude the upper extremity with low density polyethylene plastic wrap and hold in place with an elastic net dressing. Figure 3: Method of Occlusion for Upper Extremities  The patient should wear a long-sleeved shirt and/or gloves or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U Blue Light Photodynamic Therapy Illuminator treatment. Photosensitization of the treated lesions will take place over the next 3 hours. The actinic keratoses should not be washed during this time. Remove the occlusive dressing prior to light treatment and gently rinse the treated area(s) with water and pat dry before light illumination. Step B - Administration of BLU-U Treatment: LEVULAN KERASTICK is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK without subsequent BLU-U Blue Light Photodynamic Therapy Illuminator illumination is not recommended. Photoactivation of actinic keratoses treated with LEVULAN KERASTICK topical solution is accomplished with illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm2light dose. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions. Please refer to the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions for further information on conducting the light treatment. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure. 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 applying the LEVULAN KERASTICK topical solution. For patients with facial lesions :
For patients with scalp lesions:
For patients with upper extremity lesions:
Lavulan-01 Lavulan-02 Levulan-03 | 03/2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warning and Precautions, Irritation ( After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin. Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions. If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced. The LEVULAN KERASTICK topical solution contains alcohol and is intended for topical use only. Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours. | 03/2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warning and Precautions ( Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment. | 04/2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
- LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.()
2.1 Preparation and Administration OverviewAfter mixing, the LEVULAN KERASTICK 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 lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient.LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp.
2The incubation time is 3 hours for actinic keratosis lesions on the upper extremities.LEVULAN KERASTICK topical solution applicationTime window1for Blue Light Illumination for face or scalpTime window2for Blue Light Illumination for upper extremities6 am
8 pm to Midnight
9 am
7 am
9 pm to 1 am
10 am
8 am
10 pm to 2 am
11 am
9 am
11 pm to 3 am
12 Noon
10 am
Midnight to 4 am
1 pm
11 am
1 am to 5 am
2 pm
12 pm
2 am to 6 am
3 pm
1 pm
3 am to 7 am
4 pm
2 pm
4 am to 8 am
5 pm
3 pm
5 am to 9 am
6 pm
4 pm
6 am to 10 am
7 pm
5 pm
7 am to 11 am
8 pm
6 pm
8 am to Noon
9 pm
7 pm
9 am to 1 pm
10 pm
8 pm
10 am to 2 pm
11 pm
9 pm
11 am to 3 pm
12 Midnight
10 pm
Noon to 4 pm
1 am
If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, 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. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced.LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment. - Apply the drug product to the target lesions. ()
2.1 Preparation and Administration OverviewAfter mixing, the LEVULAN KERASTICK 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 lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient.LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp.
2The incubation time is 3 hours for actinic keratosis lesions on the upper extremities.LEVULAN KERASTICK topical solution applicationTime window1for Blue Light Illumination for face or scalpTime window2for Blue Light Illumination for upper extremities6 am
8 pm to Midnight
9 am
7 am
9 pm to 1 am
10 am
8 am
10 pm to 2 am
11 am
9 am
11 pm to 3 am
12 Noon
10 am
Midnight to 4 am
1 pm
11 am
1 am to 5 am
2 pm
12 pm
2 am to 6 am
3 pm
1 pm
3 am to 7 am
4 pm
2 pm
4 am to 8 am
5 pm
3 pm
5 am to 9 am
6 pm
4 pm
6 am to 10 am
7 pm
5 pm
7 am to 11 am
8 pm
6 pm
8 am to Noon
9 pm
7 pm
9 am to 1 pm
10 pm
8 pm
10 am to 2 pm
11 pm
9 pm
11 am to 3 pm
12 Midnight
10 pm
Noon to 4 pm
1 am
If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, 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. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced.LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment. - Illuminate with blue light using the BLU-U
®Blue Light Photodynamic Therapy Illuminator after the incubation time of():2.2 Dosage and Administration InstructionsStep A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical SolutionPreparation of LesionsActinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution.
Preparation of LEVULAN KERASTICK topical solutionThe LEVULAN KERASTICK applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains aminolevulinic acid HCl as a dry solid. LEVULAN KERASTICK topical solution is prepared by crushing the glass ampoules and mixing the contents together.
The LEVULAN KERASTICK topical solution can be prepared either manually, or using the optional KERASTICK KRUSHER™. These methods are illustrated below.
Figure 1: Manual Preparation:- Hold the LEVULAN KERASTICK applicator with cap point up. Crush the bottom ampule containing the solution vehicle by applying finger pressure to Position A on the cardboard sleeve.
- Crush the top ampule containing the ALA HCl powder by applying finger pressure to Position B on the cardboard sleeve. To ensure both ampules are crushed continue crushing the applicator downward, applying finger pressure to Position A. Shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle.
Figure 2: Optional KERASTICK KRUSHER Preparation:- Open the KERASTICK KRUSHER and properly position one LEVULAN KERASTICK applicator into the KRUSHER making sure to orient the LEVULAN KERASTICK label “A” with the KRUSHER “A”. Firmly seat the LEVULAN KERASTICK applicator against the closed end of the KRUSHER (cap should be at open end).
- Once positioned properly, close and firmly press the top and bottom handles together until the top and bottom handles touch one another along their length. A distinct crushing sound is made during this process. Ensure KRUSHER handles meet.
- Remove the LEVULAN KERASTICK applicator from the KRUSHER and shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle.
The LEVULAN KERASTICK topical solution must be used within two (2) hours of activation. If the solution is not completely applied within 2 hours of the activation, discard the applicator. If needed, use a new LEVULAN KERASTICK applicator.
Application of LEVULAN KERASTICK topical solutionApplication of LEVULAN KERASTICK topical solution to Face or Scalp Lesions:Following solution admixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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. Once the initial application has dried, apply again in the same manner.
Do not apply the LEVULAN KERASTICK topical solution to the periorbital area or allow it to contact ocular or mucosal surfaces.
Photosensitization of the treated lesions will take place over the next 14-18 hours. The actinic keratoses should not be washed during this time. 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 BLU-U Blue Light Photodynamic Therapy Illuminator treatment. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.
At the visit for light illumination before treatment, the actinic keratoses treated with the LEVULAN KERASTICK topical solution should be gently rinsed with water and patted dry.
For Lesions on the Upper ExtremitiesFollowing solution mixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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.Occlude the upper extremity with low density polyethylene plastic wrap and hold in place with an elastic net dressing.Figure 3: Method of Occlusion for Upper ExtremitiesThe patient should wear a long-sleeved shirt and/or gloves or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U Blue Light Photodynamic Therapy Illuminator treatment. Photosensitization of the treated lesions will take place over the next 3 hours. The actinic keratoses should not be washed during this time. Remove the occlusive dressing prior to light treatment and gently rinse the treated area(s) with water and pat dry before light illumination.Step B - Administration of BLU-U Treatment:LEVULAN KERASTICK is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK without subsequent BLU-U Blue Light Photodynamic Therapy Illuminator illumination is not recommended.
Photoactivation of actinic keratoses treated with LEVULAN KERASTICK topical solution is accomplished with illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm2light dose. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions. Please refer to the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions for further information on conducting the light treatment. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure.
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 applying the LEVULAN KERASTICK topical solution.
For patients with facial lesions:- 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.
- 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:- The knobs on either side of the BLU-U are loosened and the BLU-U is rotated to a horizontal position.
- 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.
For patients with upper extremity lesions:- The knobs on either side of the BLU-U Blue Light Photodynamic Therapy Illuminator are loosened and the light is rotated to a horizontal position.
- The BLU-U Blue Light Photodynamic Therapy Illuminator is positioned around the upper extremity so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface. A table may be used to support the upper extremities during light treatment.
Lavulan-01Lavulan-02Levulan-03- 14 to 18 hours for scalp or face
- 3 hours for upper extremities, with occlusion
- Hold the LEVULAN KERASTICK applicator with cap point up. Crush the bottom ampule containing the solution vehicle by applying finger pressure to Position A on the cardboard sleeve.
- LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks ()
2.1 Preparation and Administration OverviewAfter mixing, the LEVULAN KERASTICK 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 lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient.LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp.
2The incubation time is 3 hours for actinic keratosis lesions on the upper extremities.LEVULAN KERASTICK topical solution applicationTime window1for Blue Light Illumination for face or scalpTime window2for Blue Light Illumination for upper extremities6 am
8 pm to Midnight
9 am
7 am
9 pm to 1 am
10 am
8 am
10 pm to 2 am
11 am
9 am
11 pm to 3 am
12 Noon
10 am
Midnight to 4 am
1 pm
11 am
1 am to 5 am
2 pm
12 pm
2 am to 6 am
3 pm
1 pm
3 am to 7 am
4 pm
2 pm
4 am to 8 am
5 pm
3 pm
5 am to 9 am
6 pm
4 pm
6 am to 10 am
7 pm
5 pm
7 am to 11 am
8 pm
6 pm
8 am to Noon
9 pm
7 pm
9 am to 1 pm
10 pm
8 pm
10 am to 2 pm
11 pm
9 pm
11 am to 3 pm
12 Midnight
10 pm
Noon to 4 pm
1 am
If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, 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. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced.LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment. - For topical use only. (
2.1 Preparation and Administration OverviewAfter mixing, the LEVULAN KERASTICK 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 lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient.LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp.
2The incubation time is 3 hours for actinic keratosis lesions on the upper extremities.LEVULAN KERASTICK topical solution applicationTime window1for Blue Light Illumination for face or scalpTime window2for Blue Light Illumination for upper extremities6 am
8 pm to Midnight
9 am
7 am
9 pm to 1 am
10 am
8 am
10 pm to 2 am
11 am
9 am
11 pm to 3 am
12 Noon
10 am
Midnight to 4 am
1 pm
11 am
1 am to 5 am
2 pm
12 pm
2 am to 6 am
3 pm
1 pm
3 am to 7 am
4 pm
2 pm
4 am to 8 am
5 pm
3 pm
5 am to 9 am
6 pm
4 pm
6 am to 10 am
7 pm
5 pm
7 am to 11 am
8 pm
6 pm
8 am to Noon
9 pm
7 pm
9 am to 1 pm
10 pm
8 pm
10 am to 2 pm
11 pm
9 pm
11 am to 3 pm
12 Midnight
10 pm
Noon to 4 pm
1 am
If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, 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. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced.LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment. - See full prescribing information for complete dosage and administration instruction. ()
2 DOSAGE AND ADMINISTRATION- LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.
- Apply the drug product to the target lesions.
- Illuminate with blue light using the BLU-U®Blue Light Photodynamic Therapy Illuminator after the incubation time of:
- 14 to 18 hours for scalp or face
- 3 hours for upper extremities, with occlusion
- LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks
- For topical use only.
- See BLU-U user manual for detailed lamp safety and operating instructions.
2.1 Preparation and Administration OverviewAfter mixing, the LEVULAN KERASTICK 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 lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient.LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions.TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp.
2The incubation time is 3 hours for actinic keratosis lesions on the upper extremities.LEVULAN KERASTICK topical solution applicationTime window1for Blue Light Illumination for face or scalpTime window2for Blue Light Illumination for upper extremities6 am
8 pm to Midnight
9 am
7 am
9 pm to 1 am
10 am
8 am
10 pm to 2 am
11 am
9 am
11 pm to 3 am
12 Noon
10 am
Midnight to 4 am
1 pm
11 am
1 am to 5 am
2 pm
12 pm
2 am to 6 am
3 pm
1 pm
3 am to 7 am
4 pm
2 pm
4 am to 8 am
5 pm
3 pm
5 am to 9 am
6 pm
4 pm
6 am to 10 am
7 pm
5 pm
7 am to 11 am
8 pm
6 pm
8 am to Noon
9 pm
7 pm
9 am to 1 pm
10 pm
8 pm
10 am to 2 pm
11 pm
9 pm
11 am to 3 pm
12 Midnight
10 pm
Noon to 4 pm
1 am
If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, 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. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, gloves) 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced.LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment.2.2 Dosage and Administration InstructionsStep A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical SolutionPreparation of LesionsActinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution.
Preparation of LEVULAN KERASTICK topical solutionThe LEVULAN KERASTICK applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains aminolevulinic acid HCl as a dry solid. LEVULAN KERASTICK topical solution is prepared by crushing the glass ampoules and mixing the contents together.
The LEVULAN KERASTICK topical solution can be prepared either manually, or using the optional KERASTICK KRUSHER™. These methods are illustrated below.
Figure 1: Manual Preparation:- Hold the LEVULAN KERASTICK applicator with cap point up. Crush the bottom ampule containing the solution vehicle by applying finger pressure to Position A on the cardboard sleeve.
- Crush the top ampule containing the ALA HCl powder by applying finger pressure to Position B on the cardboard sleeve. To ensure both ampules are crushed continue crushing the applicator downward, applying finger pressure to Position A. Shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle.
Figure 2: Optional KERASTICK KRUSHER Preparation:- Open the KERASTICK KRUSHER and properly position one LEVULAN KERASTICK applicator into the KRUSHER making sure to orient the LEVULAN KERASTICK label “A” with the KRUSHER “A”. Firmly seat the LEVULAN KERASTICK applicator against the closed end of the KRUSHER (cap should be at open end).
- Once positioned properly, close and firmly press the top and bottom handles together until the top and bottom handles touch one another along their length. A distinct crushing sound is made during this process. Ensure KRUSHER handles meet.
- Remove the LEVULAN KERASTICK applicator from the KRUSHER and shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle.
The LEVULAN KERASTICK topical solution must be used within two (2) hours of activation. If the solution is not completely applied within 2 hours of the activation, discard the applicator. If needed, use a new LEVULAN KERASTICK applicator.
Application of LEVULAN KERASTICK topical solutionApplication of LEVULAN KERASTICK topical solution to Face or Scalp Lesions:Following solution admixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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. Once the initial application has dried, apply again in the same manner.
Do not apply the LEVULAN KERASTICK topical solution to the periorbital area or allow it to contact ocular or mucosal surfaces.
Photosensitization of the treated lesions will take place over the next 14-18 hours. The actinic keratoses should not be washed during this time. 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 BLU-U Blue Light Photodynamic Therapy Illuminator treatment. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.
At the visit for light illumination before treatment, the actinic keratoses treated with the LEVULAN KERASTICK topical solution should be gently rinsed with water and patted dry.
For Lesions on the Upper ExtremitiesFollowing solution mixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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.Occlude the upper extremity with low density polyethylene plastic wrap and hold in place with an elastic net dressing.Figure 3: Method of Occlusion for Upper ExtremitiesThe patient should wear a long-sleeved shirt and/or gloves or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U Blue Light Photodynamic Therapy Illuminator treatment. Photosensitization of the treated lesions will take place over the next 3 hours. The actinic keratoses should not be washed during this time. Remove the occlusive dressing prior to light treatment and gently rinse the treated area(s) with water and pat dry before light illumination.Step B - Administration of BLU-U Treatment:LEVULAN KERASTICK is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK without subsequent BLU-U Blue Light Photodynamic Therapy Illuminator illumination is not recommended.
Photoactivation of actinic keratoses treated with LEVULAN KERASTICK topical solution is accomplished with illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm2light dose. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions. Please refer to the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions for further information on conducting the light treatment. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure.
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 applying the LEVULAN KERASTICK topical solution.
For patients with facial lesions:- 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.
- 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:- The knobs on either side of the BLU-U are loosened and the BLU-U is rotated to a horizontal position.
- 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.
For patients with upper extremity lesions:- The knobs on either side of the BLU-U Blue Light Photodynamic Therapy Illuminator are loosened and the light is rotated to a horizontal position.
- The BLU-U Blue Light Photodynamic Therapy Illuminator is positioned around the upper extremity so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface. A table may be used to support the upper extremities during light treatment.
Lavulan-01Lavulan-02Levulan-03 - See BLU-U user manual for detailed lamp safety and operating instructions. ()
2.2 Dosage and Administration InstructionsStep A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical SolutionPreparation of LesionsActinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution.
Preparation of LEVULAN KERASTICK topical solutionThe LEVULAN KERASTICK applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains aminolevulinic acid HCl as a dry solid. LEVULAN KERASTICK topical solution is prepared by crushing the glass ampoules and mixing the contents together.
The LEVULAN KERASTICK topical solution can be prepared either manually, or using the optional KERASTICK KRUSHER™. These methods are illustrated below.
Figure 1: Manual Preparation:- Hold the LEVULAN KERASTICK applicator with cap point up. Crush the bottom ampule containing the solution vehicle by applying finger pressure to Position A on the cardboard sleeve.
- Crush the top ampule containing the ALA HCl powder by applying finger pressure to Position B on the cardboard sleeve. To ensure both ampules are crushed continue crushing the applicator downward, applying finger pressure to Position A. Shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle.
Figure 2: Optional KERASTICK KRUSHER Preparation:- Open the KERASTICK KRUSHER and properly position one LEVULAN KERASTICK applicator into the KRUSHER making sure to orient the LEVULAN KERASTICK label “A” with the KRUSHER “A”. Firmly seat the LEVULAN KERASTICK applicator against the closed end of the KRUSHER (cap should be at open end).
- Once positioned properly, close and firmly press the top and bottom handles together until the top and bottom handles touch one another along their length. A distinct crushing sound is made during this process. Ensure KRUSHER handles meet.
- Remove the LEVULAN KERASTICK applicator from the KRUSHER and shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle.
The LEVULAN KERASTICK topical solution must be used within two (2) hours of activation. If the solution is not completely applied within 2 hours of the activation, discard the applicator. If needed, use a new LEVULAN KERASTICK applicator.
Application of LEVULAN KERASTICK topical solutionApplication of LEVULAN KERASTICK topical solution to Face or Scalp Lesions:Following solution admixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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. Once the initial application has dried, apply again in the same manner.
Do not apply the LEVULAN KERASTICK topical solution to the periorbital area or allow it to contact ocular or mucosal surfaces.
Photosensitization of the treated lesions will take place over the next 14-18 hours. The actinic keratoses should not be washed during this time. 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 BLU-U Blue Light Photodynamic Therapy Illuminator treatment. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.
At the visit for light illumination before treatment, the actinic keratoses treated with the LEVULAN KERASTICK topical solution should be gently rinsed with water and patted dry.
For Lesions on the Upper ExtremitiesFollowing solution mixture, remove the cap from the LEVULAN KERASTICK applicator. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. 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.Occlude the upper extremity with low density polyethylene plastic wrap and hold in place with an elastic net dressing.Figure 3: Method of Occlusion for Upper ExtremitiesThe patient should wear a long-sleeved shirt and/or gloves or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U Blue Light Photodynamic Therapy Illuminator treatment. Photosensitization of the treated lesions will take place over the next 3 hours. The actinic keratoses should not be washed during this time. Remove the occlusive dressing prior to light treatment and gently rinse the treated area(s) with water and pat dry before light illumination.Step B - Administration of BLU-U Treatment:LEVULAN KERASTICK is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK without subsequent BLU-U Blue Light Photodynamic Therapy Illuminator illumination is not recommended.
Photoactivation of actinic keratoses treated with LEVULAN KERASTICK topical solution is accomplished with illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm2light dose. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions. Please refer to the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions for further information on conducting the light treatment. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure.
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 applying the LEVULAN KERASTICK topical solution.
For patients with facial lesions:- 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.
- 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:- The knobs on either side of the BLU-U are loosened and the BLU-U is rotated to a horizontal position.
- 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.
For patients with upper extremity lesions:- The knobs on either side of the BLU-U Blue Light Photodynamic Therapy Illuminator are loosened and the light is rotated to a horizontal position.
- The BLU-U Blue Light Photodynamic Therapy Illuminator is positioned around the upper extremity so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface. A table may be used to support the upper extremities during light treatment.
Lavulan-01Lavulan-02Levulan-03 - Hold the LEVULAN KERASTICK applicator with cap point up. Crush the bottom ampule containing the solution vehicle by applying finger pressure to Position A on the cardboard sleeve.
For topical solution: 354 mg of aminolevulinic acid hydrochloride as a powder in a plastic applicator device. Upon mixture, LEVULAN KERASTICK is a topical solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight.
Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown
Two human pharmacokinetic (PK) studies were conducted in subjects with minimally to moderately thick actinic keratoses on the upper extremities, having at least 6 lesions on one upper extremity and at least 12 lesions on the other upper extremity. A single dose comprising of two topical applications of LEVULAN KERASTICK topical solution (each containing 354 mg ALA HCl) were directly applied to the lesions and occluded for 3 hours prior to light treatment.
The first PK study was conducted in 29 subjects and PK parameters of ALA were assessed. The baseline-corrected mean ± SD of the maximum concentration (Cmax) of ALA was 249.9 ± 694.5 ng/mL and the median time to reach Cmax(Tmax) was 2 hr post dose. The mean ± SD exposure to ALA, as expressed by area under the concentration time curve (AUCt) was 669.9 ± 1610 ng∙hr/mL. The mean ± SD elimination half-life (T1/2) of ALA was 5.7 ± 3.9 hr.
A second PK study was conducted in 14 subjects and PK parameters of ALA and PpIX were measured. The baseline-corrected PpIX concentrations were negative in at least 50% of samples in 50% (7/14) subjects and AUC could not be estimated reliably. The baseline-corrected mean ± SD of Cmaxfor ALA and PpIX was 95.6 ± 120.6 ng/mL and 0.95 ± 0.71 ng/mL, respectively. The median Tmaxof ALA and PpIX was 2 hr post dose and 12 hr post dose, respectively. The mean AUCtof ALA was 261.1 ± 229.3 ng∙hr/mL. The mean ± SD T1/2of ALA was 8.5 ± 6.7 hr.
The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with:
- Cutaneous photosensitivity at wavelengths of 400-450 nm[see]
5.2 PhotosensitivityAfter LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions.Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin.Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions.If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced. - Porphyria or known allergies to porphyrins[see]
5.2 PhotosensitivityAfter LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions.Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin.Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions.If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced. - Known sensitivity to any of the components of the LEVULAN KERASTICK.