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
Xeloda Side Effects, and Drug Interactions - Capecitabine
Xeloda Side Effects, and Drug Interactions - Capecitabine
SIDE EFFECTS
The following table shows the adverse events occurring in ³5%
of patients reported as at least remotely related to the administration
of XELODA. Rates are rounded to the nearest whole number. The data are
shown both for the study in stage IV breast cancer and for a group of
570 patients with breast and colorectal cancer who received a dose of
2510 mg/m2 administered daily for 2 weeks followed by a 1-week
rest period. The 570 patients were enrolled in 6 clinical trials (162
from the breast cancer trial described under CLINICAL STUDIES, 83 other
patients with breast cancer and 325 patients with colorectal cancer).
The mean duration of treatment was 121 days. A total of 71 patients (13%)
discontinued treatment because of adverse events/intercurrent illness.
|
Table 3. Percent Incidence of Adverse Events
Considered Remotely, Possibly or Probably Related to
Treatment in ³5% of Patients
|
|
Adverse
Event
|
Phase 2 Trial in
Stage IV Breast Cancer
(n= 162) |
Overall Safety
Database
(n= 570) |
|
Body System/
Adverse Event
|
Total |
Grade 3 |
Grade 4 |
Total |
Grade 3 |
Grade 4 |
|
GI
|
| Diarrhea |
57 |
12 |
3 |
50 |
11 |
2 |
| Nausea |
53 |
4 |
- |
44 |
4 |
- |
| Vomiting |
37 |
4 |
- |
26 |
3 |
- |
| Stomatitis |
24 |
7 |
- |
23 |
4 |
- |
| Abdominal pain |
20 |
4 |
- |
17 |
4 |
- |
| Constipation |
15 |
1 |
- |
9 |
1 |
- |
| Dyspepsia |
8 |
- |
- |
6 |
- |
- |
|
Skin and Subcutaneous
|
| Hand-and-Foot Syndrome |
57 |
11 |
- |
45 |
13 |
- |
| Dermatitis |
37 |
1 |
- |
31 |
1 |
- |
| Nail disorder |
7 |
- |
- |
4 |
- |
- |
| General |
| Fatigue |
41 |
8 |
- |
34 |
5 |
- |
| Pyrexia |
12 |
1 |
- |
10 |
- |
- |
| Pain in limb |
6 |
1 |
- |
4 |
- |
- |
| Neurological |
| Paraesthesia |
21 |
1 |
- |
12 |
- |
- |
| Headache |
9 |
1 |
- |
7 |
1 |
- |
| Dizziness |
8 |
- |
- |
5 |
- |
- |
| Insomnia |
8 |
- |
- |
3 |
- |
- |
| Metabolism |
| Anorexia |
23 |
3 |
- |
20 |
2 |
- |
| Dehydration |
7 |
4 |
1 |
5 |
2 |
1 |
| Eye |
| Eye irritation |
15 |
- |
- |
10 |
- |
- |
| Musculoskeletal |
| Myalgia |
9 |
- |
- |
4 |
- |
- |
| Cardiac |
| Edema |
9 |
1 |
- |
6 |
- |
- |
| Blood |
| Neutropenia |
26 |
2 |
2 |
22 |
3 |
2 |
| Thrombocytopenia |
24 |
3 |
1 |
21 |
1 |
1 |
| Anemia |
72 |
3 |
1 |
74 |
2 |
1 |
| Lymphopenia |
94 |
44 |
15 |
94 |
36 |
10 |
| Hepatobiliary |
| Hyperbilirubinemia |
22 |
9 |
2 |
34 |
14 |
3 |
|
– Not observed or applicable.
Shown below by body system are the adverse events in <5% of patients
reported as related to the administration of XELODA and that were clinically
at least remotely relevant. In parentheses is the incidence of grade 3
or 4 occurrences of each adverse event.
Gastrointestinal: intestinal obstruction (11), rectal bleeding
(0.4), GI hemorrhage (0.2), esophagitis (0.4), gastritis, colitis, duodenitis,
haematemesis, necrotizing enterocolitis.
Skin: increased sweating (0.2), photosensitivity (0.2),
radiation recall syndrome (0.2).
General: chest pain (0.2).
Neurological: ataxia (0.4), encephalopathy (0.2), depressed
level of consciousness (0.2), loss of consciousness (0.2).
Metabolism: cachexia (0.4), hypertriglyceridemia (0.2).
Respiratory: dyspnea (0.5), epistaxis (0.2), bronchospasm
(0.2), respiratory distress (0.2).
Infections: oral candidiasis (0.2), upper respiratory tract
infection (0.2), urinary tract infection (0.2), bronchitis (0.2), pneumonia
(0.2), sepsis (0.4), bronchopneumonia (0.2), gastroenteritis (0.2), gastrointestinal
candidiasis (0.2), laryngitis (0.2), esophageal candidiasis (0.2).
Musculoskeletal: bone pain (0.2), joint stiffness (0.2).
Cardiac: angina pectoris (0.2), cardiomyopathy (0.2).
Vascular: hypotension (0.2), hypertension (0.2), venous
phlebitis and thrombophlebitis (0.2), deep venous thrombosis (0.7), lymphoedema
(0.2), pulmonary embolism (0.4), cerebrovascular accident (0.2).
Blood: coagulation disorder (0.2), idiopathic thrombocytopenic
purpura (0.2), pancytopenia (0.2).
Psychiatric: confusion (0.2).
Renal and Urinary: nocturia (0.2).
Hepatobiliary: hepatic fibrosis (0.2), cholestatic hepatitis
(0.2), hepatitis (0.2).
Immune System: drug hypersensitivity (0.2).
DRUG INTERACTIONS
Antacid
The effect of an aluminum hydroxide- and magnesium hydroxide-containing
antacid (Maalox)* on the pharmacokinetics of capecitabine was investigated
in 12 cancer patients. There was a small increase in plasma concentrations
of capecitabine and one metabolite (5'-DFCR); there was no effect on the
3 major metabolites (5'-DFUR, 5-FU and FBAL).
Coumarin Anticoagulants
Altered coagulation parameters and/or bleeding have been reported in
patients taking capecitabine concomitantly with coumarin-derivative anticoagulants
such as warfarin and phenprocoumon. Patients taking coumarin-derivative
anticoagulants concomitantly with capecitabine should be monitored regularly
for alterations in their coagulation parameters (PT or INR) (see WARNINGS:
Coagulopathy).
Leucovorin
The concentration of 5-fluorouracil is increased and its toxicity may
be enhanced by leucovorin. Deaths from severe enterocolitis, diarrhea,
and dehydration have been reported in elderly patients receiving weekly
leucovorin and fluorouracil.
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