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
Panretin Side Effects, and Drug Interactions - Alitretinoin
Panretin Side Effects, and Drug Interactions - Alitretinoin
SIDE EFFECTS
The safety of Panretin® gel
has been assessed in clinical
studies of 385 patients with AIDS-related KS. Adverse events associated
with the use of Panretin® gel
in patients with AIDS-related KS occurred almost exclusively at the site
of application. The dermal toxicity
begins as erythema; with continued application of Panretin® gel, erythema
may increase and edema may develop.
Dermal toxicity may become
treatment-limiting, with intense erythema,
edema, and vesiculation. Usually,
however, adverse events are mild to moderate in severity; they led to
withdrawal from the study
in only 7% of the patients. Severe local
(application site) skin adverse
events occurred in about 10% of patients in the U.S. study (versus 0%
in the vehicle control). Table
2 lists the adverse events that occurred at the application site
with an incidence of at
least 5% during the double-blind phase in the Panretin® gel-treated
group and in the vehicle
control group in either of the two controlled studies. Adverse events
were reported at other sites but generally were similar in the two groups.
TABLE 2:
Adverse Events with an Incidence of at Least 5% at the Application
Site in Either Controlled Study in Patients Receiving Panretin®
Gel or Vehicle Control
|
Adverse Event Term
|
Study 1
|
Study 2
|
| |
Panretin ® Gel
N= 134 Pts.
%
|
Vehicle Gel
N= 134 Pts.
%
|
Panretin ® Gel
N= 36 Pts.
%
|
Vehicle Gel
N= 46 Pts.
%
|
| Rash1 |
77
|
11
|
25
|
4
|
| Pain2 |
34
|
7
|
0
|
4
|
| Pruritus3 |
11
|
4
|
8
|
4
|
| Exfoliative dermatitis4 |
9
|
2
|
3
|
0
|
| Skin disorder5 |
8
|
1
|
0
|
0
|
| Paresthesia6 |
3
|
0
|
22
|
7
|
| Edema7 |
8
|
3
|
3
|
0
|
Includes Investigator terms:
1 Erythema, scaling, irritation, redness, rash,
dermatitis
2 Burning, pain
3 Itching, pruritis
4 Flaking, peeling, desquamation, exfoliation
5 Excoriation, cracking, scab, crusting, drainage, eschar,
fissure or oozing
6 Stinging, tingling
7 Edema, swelling, inflammation
DRUG INTERACTIONS
Patients who are applying Panretin® gel
should not concurrently use products that contain DEET
(N, N-diethyl-m-toluamide), a common component of insect
repellent products. Animal
toxicology studies showed
increased DEET toxicity when
DEET was included as proof of
the formulation. Although there was no
clinical evidence
in the vehicle-controlled studies of drug interactions with systemic
antiretroviral agents,
including protease inhibitors, macrolide antibiotics, and azole antifungals,
the effect of Panretin®
gel on the steady-state concentrations of these drugs is not known. No
drug interaction data are available on concomitant
administration of Panretin®
gel and systemic anti-KS
agents.
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