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
Eulexin Side Effects, and Drug Interactions - Flutamide
Eulexin Side Effects, and Drug Interactions - Flutamide
SIDE EFFECTS
Stage B2-C Prostatic Carcinoma
Treatment with EULEXIN Capsules and the LHRH
agonist did not add
substantially to the toxicity
of radiation treatment
alone. The following adverse experiences were reported during a
multicenter clinical
trial comparing EULEXIN Capsules + LHRH-A +radiation versus radiation
alone. The most frequently reported (greater than 5%) adverse experiences
are listed below.
|
Adverse Events During Acute Radiation
Therapy
(within first 90 days of radiation therapy)
|
|
|
(n= 231)
LHRH -A +
EULEXIN Capsules +
Radiation
% All
|
(n= 235)
Radiation
Only
% All
|
| Rectum/Large Bowel
|
80
|
76
|
| Bladder |
58
|
60
|
| Skin |
37
|
37
|
|
Adverse Events During Late Radiation
Phase
(after 90 days of radiation therapy)
|
|
|
(n= 231)
LHRH-A +
EULEXlN Capsules +
Radiation
%All
|
(n= 235)
Radiation
Only
%All
|
| Diarrhea |
36
|
40
|
| Cystitis |
16
|
16
|
| Rectal Bleeding |
14
|
20
|
| Proctitis |
8
|
8
|
| Hematuria |
7
|
12
|
Additional adverse event data was collected for the combination
therapy with radiation
group over both the hormonal
treatment and hormonal
treatment plus radiation
phases of the study. Adverse experiences occurring in more than
5% of patients in this group, over both parts of the study, were
hot flashes (46%), diarrhea
(40%), nausea (9%), and
skin rash
(8%).
Stage D2 Metastatic Carcinoma
The following adverse experiences were reported during a multi-center
clinical trial comparing EULEXIN Capsules + LHRH
agonist versus placebo
+ LHRH agonist.
The most frequently reported (greater than 5%) adverse experiences
during treatment with EULEXIN Capsules in combination with an LHRH
agonist are listed in
the table below. For comparison,
adverse experiences seen with an LHRH
agonist and placebo
are also listed in the following table.
|
|
(n= 294)
Flutamide +
LHRH
agonist
%All
|
(n= 285)
Placebo +
LHRA
agonist
%All
|
| Hot Flashes |
61
|
57
|
| Loss of Libido |
36
|
31
|
| Impotence |
33
|
29
|
| Diarrhea |
12
|
4
|
| Nausea/ Vomiting
|
11
|
10
|
| Gynecomastia |
9
|
11
|
| Other |
7
|
9
|
| Other GI |
6
|
4
|
As shown in the table, for both treatment
groups, the most frequently occurring adverse experiences (hot flashes,
impotence, loss of libido)
were those known to be associated with low serum androgen levels
and known to occur with LHRH
agonists alone.
The only notable difference was the higher incidence
of diarrhea in the
flutamide + LHRH agonist
group (12%), which was
severe in 5% as opposed to the placebo
+ LHRH agonist
(4%), which was severe in less than1%.
In addition, the following adverse reactions were reported during
treatment with flutamide + LHRH
agonist. No causal relatedness
of these reactions to drug
treatment has been
made, and some of the adverse experiences reported are those that
commonly occur in elderly patients.
Cardiovascular System: hypertension
in 1% of patients.
Central Nervous System: CNS
(drowsiness/confusion/depression/anxiety/nervousness) reactions
occurred in 1% of patients.
Gastrointestinal System: anorexia
4%, and other GI disorders
occurred in 6% of patients.
Hematopoietic System: anemia
occurred in 6%, leukopenia in 3%, and thrombocytopenia
in 1% of patients.
Liver and Biliary System: hepatitis
and jaundice in less
than 1% of patients.
Skin: irritation
at the injection site
and rash occurred in 3%
of patients.
Other: edema
occurred in 4%, genitourinary
and neuromuscular symptoms in 2%, and pulmonary
symptoms in less than 1% of patients.
In addition, the following spontaneous
adverse experiences have been reported during the marketing of flutamide:
hemolytic anemia,
macrocytic anemia, methemoglobinemia,
photosensitivity
reactions (including erythema, ulceration, bullous
eruptions, and epidermal necrolysis), and urine
discoloration. The urine
was noted to change to an amber or yellow-green appearance
which can be attributed to the flutamide and/or its metabolites.
Also reported were cholestatic jaundice,
hepatic encephalopathy,
and hepatic necrosis.
The hepatic conditions
were usually reversible
after discontinuing therapy; however, there have been reports of
death following severe
hepatic injury associated
with use of flutamide.
Malignant breast neoplasms have occured in male patients being treated with EULEXIN Capsules.
Abnormal Laboratory Test Values: Laboratory abnormalities
including elevated SGOT, SGPT, bilirubin
values, SGGT, BUN, and serum
creatinine have been reported.
DRUG INTERACTIONS
Increases in prothrombin
time have been noted in
patients receiving long- term
warfarin therapy after
flutamide was initiated. Therefore, close monitoring of prothrombin
time is recommended and
adjustment of the
anticoagulant dose may be necessary when EULEXIN Capsules are administered
concomitantly with warfarin.
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