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 Side Effects, and Drug Interactions - Aminolevulinic Acid
Levulan Kerastick Side Effects, and Drug Interactions - Aminolevulinic Acid
SIDE EFFECTS
In Phase 3 studies, no non-cutaneous adverse events were found to be
consistently associated with LEVULAN KERASTICK Topical Solution application
followed by blue light exposure.
Photodynamic Therapy Response
The constellation of transient local symptoms of stinging and/or burning,
itching, erythema and edema as a result of LEVULAN KERASTICK Topical Solution
plus BLU-U treatment was observed in all clinical studies of LEVULAN KERASTICK
for Topical Solution Photodynamic Therapy for actinic keratoses treatment.
Stinging and/or burning subsided between 1 minute and 24 hours after the
BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and
appeared qualitatively similar to that perceived by patients with erythropoietic
protoporphyria upon exposure to sunlight. There was no clear drug dose
or light dose dependent change in the incidence or severity of stinging
and/or burning.
In the two Phase 3 trials, the sensation of stinging and/or burning appeared
to reach a plateau at 6 minutes into the treatment. 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. The majority of patients
reported that all lesions treated exhibited at least slight stinging and/or
burning. Less than 3% of patients discontinued light treatment due to
stinging and/or burning.
The most common changes in lesion appearance after LEVULAN KERASTICK
for Topical Solution Photodynamic Therapy were erythema and edema. In
99% of active treatment patients, some or all lesions were erythematous
shortly after treatment, while in 79% of vehicle treatment patients, some
or all lesions were erythematous. In 35% of active treatment patients,
some or all lesions were edematous, while no vehicle-treated patients
had edematous lesions. Both erythema and edema resolved to baseline or
improved by 4 weeks after therapy. LEVULAN KERASTICK Topical Solution
application to photodamaged perilesional skin resulted in photosensitization
of photodamaged skin and in a photodynamic response. (see PRECAUTIONS).
Other Localized Cutaneous Adverse Experiences: Table 5 depicts
the incidence and severity of cutaneous adverse events, stratified
by anatomic site treated.
|
Table 5. Post-PDT Cutaneous Adverse Events
– ALA-018/ ALA-019
|
|
|
FACE
|
SCALP
|
|
|
LEVULAN (n=139)
|
Vehicle (n=41)
|
LEVULAN(n=42)
|
Vehicle (n=21)
|
|
Degree of Severity
|
Mild/ Moderate
|
Severe
|
Mild/ Moderate
|
Severe
|
Mild/ Moderate
|
Severe
|
Mild/ Moderate
|
Severe
|
| Scaling/ Crusting |
71% |
1% |
12% |
0% |
64% |
2% |
19% |
0% |
| Pain |
1% |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
| Tenderness |
1% |
0% |
0% |
0% |
2% |
0% |
0% |
0% |
| Itching |
25% |
1% |
7% |
0% |
14% |
7% |
19% |
0% |
| Edema |
1% |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
| Ulceration |
4% |
0% |
0% |
0% |
2% |
0% |
0% |
0% |
| Bleeding/ Hemorrhage |
4% |
0% |
0% |
0% |
2% |
0% |
0% |
0% |
| Hypo/ hyperpigmentation |
22%
|
20%
|
36%
|
33%
|
| Vesiculation |
4% |
0% |
0% |
0% |
5% |
0% |
0% |
0% |
| Pustules |
4% |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
| Oozing |
1% |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
| Dysesthesia |
2% |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
| Scabbing |
2% |
1% |
0% |
0% |
0% |
0% |
0% |
0% |
| Erosion |
14% |
1% |
0% |
0% |
02% |
0% |
0% |
0% |
| Excoriation |
1% |
0% |
0% |
0% |
0% |
0% |
0% |
0% |
| Wheal/ Flare |
7% |
1% |
0% |
0% |
2% |
0% |
0% |
0% |
| Skin disorder NOS |
5% |
0% |
0% |
0% |
12% |
0% |
5% |
0% |
Adverse Experiences Reported by Body System
In the Phase 3 studies, 7 patients experienced a serious adverse event.
All were deemed remotely or not related to treatment. No clinically significant
patterns of clinical laboratory changes were observed for standard serum
chemical or hematologic parameters in any of the controlled clinical trials.
DRUG INTERACTIONS
There have been no formal studies of the interaction of LEVULAN KERASTICK
for Topical Solution with any other drugs, and no drug-specific interactions
were noted during any of the controlled clinical trials. It is, however,
possible that concomitant use of other known photosensitizing agents such
as griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides
and tetracyclines might increase the photosensitivity reaction of actinic
keratoses treated with the LEVULAN KERASTICK for Topical Solution.
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