A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Levulan Kerastick Indications, Dosage, Storage, Stability - Aminolevulinic Acid
Levulan Kerastick Indications, Dosage, Storage, Stability - Aminolevulinic Acid
INDICATIONS
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 (Grade 1 or 2, see table 2 for definition) of
the face or scalp.
DOSAGE AND ADMINISTRATION
LEVULAN KERASTICK for Topical Solution 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 Topical Solution and one
dose of illumination per treatment site per 8-week treatment session.
Each individual LEVULAN KERASTICK 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, 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 wwindow following application. Patients
in clinical trials usually received application in the late afternoon,
with illumination the following morning.
|
Table 6. Schedule for LEVULAN and Blue Light
Administration
|
|
LEVULAN KERASTICK Topical Solution Application
|
Time Window for Blue Light Illumination
|
| 6am |
8pm to midnight |
| 7am |
9pm to 1am |
| 8am |
10pm to 2am |
| 9am |
11pm to 3am |
| 10am |
Midnight to 4am |
| 11am |
1am to 5am |
| 12am |
2am to 6am |
| 1pm |
3am to 7am |
| 2pm |
4am to 8am |
| 3pm |
5am to 9am |
| 4pm |
6am to 10am |
| 5pm |
7am to 11am |
| 6pm |
8am to Noon |
| 7pm |
9am to 1pm |
| 8pm |
10am to 2pm |
| 9pm |
11am to 3pm |
| 10pm |
Noon to 4pm |
Treated lesions that have not completely resolved after 8 weeks may be
treated a second time with LEVULAN KERASTICK for Topical Solution Photodynamic
Therapy. Patients did not receive follow-up past 12 weeks after the initial
treatment, so the incidence of recurrence of treated lesions past 12 weeks
and the role of further treatment is not known.
Step A - LEVULAN KERASTICK for Topical Solution Application
Actinic keratoses targeted for treatment should be clean and dry prior
to application of LEVULAN KERASTICK Topical Solution.
Preparation:
The LEVULAN KERASTICK Topical Solution should be prepared as follows:
(1) Hold the LEVULAN KERASTICK so that the applicator cap is pointing
up.
(2) Crush the bottom ampule containing the solution vehicle by applying
finger pressure .
(3) Crush the top ampule containing the ALA HCl powder by applying finger
pressure. Continue crushing the applicator downward, applying finger pressure
.
(4) Holding the LEVULAN KERASTICK between the thumb and forefinger, point
the applicator cap away from the face, shake the LEVULAN KERASTICK gently
for at least 3 minutes to completely dissolve the drug powder in the solution
vehicle.
LEVULAN KERASTICK Preparation:
Following solution admixture, remove the cap from the LEVULAN KERASTICK.
The dry applicator tip should be dabbed on a gauze pad until uniformly
wet with solution.
Application:
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. The effect of LEVULAN KERASTICK Topical Solution on ocular tissues
is unknown. LEVULAN KERASTICK Topical Solution should not be applied to
the periorbital area or allowed to contact ocular or mucosal surfaces.
Once the initial application has dried, apply again in the same manner.
The LEVULAN KERASTICK Topical Solution must be used immediately following
preparation (dissolution) due to the instability of the activated product.
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.
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 keratosis lesions from sunlight or
other bright light sources until BLU-U treatment. The patient should be
advised to reduce light exposure if the sensations of stinging and/or
burning are experienced.
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. The patient should be advised to wear a
wide-brimmed hat or other protective apparel to shade the treated actinic
keratosis lesions from sunlight or other bright light sources until at
least 40 hours after the application of LEVULAN KERASTICK Topical Solution.
The patient should be advised to reduce light exposure if the sensations
of stinging and/or burning are experienced.
Step B - Administration of BLU-U Treatment 14 to 18 hours after application
of LEVULAN KERASTICK Topical Solution
At the visit for light illumination, the actinic keratoses to be treated
should be gently rinsed with water and patted dry. 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. A 1000 second (16 minutes 40 seconds) exposure is required
to provide a 10 J/ cm ² light dose. 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. Please refer to the BLU-U 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 application of the LEVULAN KERASTICK Topical Solution from
the first visit.
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.
A Chin Rest, available from DUSA Pharmaceuticals, Inc., may be
used to provide support for the patient’s head during treatment.
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.
A Chin Rest, available from DUSA Pharmaceuticals, Inc., may be used to
provide support for the patient’s head during treatment.
LEVULAN KERASTICK for Topical Solution is not intended for use with
any device other than the BLU-U Blue Light Photodynamic Illuminator. Use
of LEVULAN KERASTICK for Topical Solution without subsequent BLU-U illumination
is not recommended.
HOW SUPPLIED
The LEVULAN KERASTICK for Topical Solution, 20%, is a single-unit dosage
form, supplied in packs of 4, 6 or 12. Each LEVULAN KERASTICK for Topical
Solution 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 354 mg of aminolevulinic acid HCl.
The applicator is covered with a protective cardboard sleeve and cap.
| Product Package |
NDC number
|
| Individual LEVULAN KERASTICK for Topical Solution, 20%
|
67308-101-01
|
| Carton of 6 LEVULAN KERASTICKS for Topical Solution, 20%
|
67308-101-06
|
Storage Conditions: Store between 20°– 25°C (68°– 77°F); excursions
permitted to 15°– 30°C (59°– 86°F) [See USP Controlled
Room Temperature]. The LEVULAN KERASTICK for Topical Solution
should be used immediately following preparation (dissolution).
Solution application must be completed within 2 hours of preparation.
An applicator that has been prepared must be discarded 2
hours after mixing (dissolving) and a new LEVULAN KERASTICK for
Topical Solution used, if needed.
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