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 Indications, Dosage, Storage, Stability - Capecitabine
Xeloda Indications, Dosage, Storage, Stability - Capecitabine
INDICATIONS
XELODA is indicated for the treatment of patients with metastatic breast
cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy
regimen or resistant to paclitaxel and for whom further anthracycline
therapy is not indicated, e.g., patients who have received cumulative
doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.
Resistance is defined as progressive disease while on treatment, with
or without an initial response, or relapse within 6 months of completing
treatment with an anthracycline-containing adjuvant regimen.
This indication is based on demonstration of a response rate. No results
are available from controlled trials that demonstrate a clinical benefit
resulting from treatment, such as improvement in diseaserelated symptoms,
disease progression, or survival.
DOSAGE AND ADMINISTRATION
The recommended dose of XELODA is 2500 mg/m2 administered
orally daily with food for 2 weeks followed by a 1-week rest period given
as 3 week cycles. The XELODA daily dose is given orally in two divided
doses (approximately 12 hours apart) at the end of a meal. XELODA tablets
should be swallowed with water. The following table displays the total
daily dose by body surface area and the number of tablets to be taken
at each dose.
|
Table 4. XELODA Dose Calculation According to
Body Surface Area
|
| Dose level 2500 mg/m2/day |
Number of tablets to be taken
at
each dose (morning and evening) |
| Surface Area (m2) |
Total Dailly*
Dose (mg) |
150 mg |
500 mg |
| £1.24 |
3000 |
0 |
3 |
| 1.25-1.36 |
3300 |
1 |
3 |
| 1.37-1.51 |
3600 |
2 |
3 |
| 1.52-1.64 |
4000 |
0 |
4 |
| 1.65-1.76 |
4300 |
1 |
4 |
| 1.77-1.91 |
4600 |
2 |
4 |
| 1.92-2.04 |
5000 |
0 |
5 |
| 2.05-2.17 |
5300 |
1 |
5 |
| ³ 2.18 |
5600 |
2 |
5 |
|
*Total Daily Dose divided by 2 to allow equal morning and evening doses.
Dose Modification Guidelines
Patients should be carefully monitored for toxicity. Toxicity due to
XELODA administration may be managed by symptomatic treatment, dose interruptions
and adjustment of XELODA dose. Once the dose has been reduced it should
not be increased at a later time.
|
Table 5. Recommended Dose Modifications
|
Toxicity
NCIC Grades* |
During a
Course of Therapy |
Dose Adjustment
for Next Cycle
(% of starting dose) |
| •Grade 1 |
Maintain dose level |
Maintain dose level |
| •Grade 2 |
| -1st appearance |
Interrupt until
resolved to grade 0-1 |
100% |
| -2nd appearance |
Interrupt until
resolved to grade 0-1 |
75% |
| -3rd appearance |
Interrupt until
resolved to grade 0-1 |
50% |
| -4th appearance |
Discontinue treatment
permanently |
|
| • Grade 3 |
| -1 st appearance |
Interrupt until
resolved to grade 0-1 |
75% |
| -2nd appearance |
Interrupt until
resolved to grade 0-1 |
50% |
| -3rd appearance |
Discontinue treatment
permanently |
|
| •Grade 4 |
| -1 st appearance |
Discontinue
permanently
or
If physician deems it to
be in the patient's best
interest to continue,
interrupt until resolved
to grade 0-1
|
50%
|
|
*National Cancer Institute of Canada Common Toxicity Criteria were used
except for the Hand-and-Foot Syndrome (see PRECAUTIONS).
Dosage modifications are not recommended for grade 1 events.Therapy with
XELODA should be interrupted upon the occurrence of a grade 2 or 3 adverse
experience. Once the adverse event has solved or decreased in intensity
to grade 1, then XELODA therapy may be restarted at full dose or as adjusted
according to the above table. If a grade 4 experience occurs, therapy
should be discontinued or interrupted until resolved or decreased to grade
1,and therapy should be restarted at 50% of the original dose. Doses of
capecitabine omitted for toxicity are not replaced or restored; instead
the patient should resume the planned treatment cycles.
Adjustment of Starting Dose in Special Populations
Hepatic Impairment: In patients with mild to moderate hepatic
dysfunction due to liver metastases, no starting dose adjustment is necessary;
however, patients should be carefully monitored. Patients with severe
hepatic dysfunction have not been studied.
Renal Impairment: Insufficient data are available in patients
with renal impairment to provide a dosage recommendation.
Geriatrics: The elderly may be pharmacodynamically more
sensitive to the toxic effects of 5-FU and therefore, physicians should
exercise caution in monitoring the effects of XELODA in the elderly. Insufficient
data are available to provide a dosage recommendation.
HOW SUPPLIED
XELODA is supplied as biconvex, oblong filmcoated tablets, available
in bottles as follows:
150 mg
color: light peach
engraving: XELODA on one side, 150 on the other
150 mg tablets packaged in bottles of 120 (NDC 0004-1100-51)
500 mg
color: peach
engraving: XELODA on one side, 500 on the other
500 mg tablets packaged in bottles of 240 (NDC 0004-1101-16)
Storage Conditions
Store at 25° C (77° F); excursions permitted to 15° to 3O° C (59°
to 86° F), keep tightly closed. [See USP Controlled Room Temperature]
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