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| Body Surface Area (m2) | Total Daily Dose (mg) |
|---|---|
| ≤1.25 | 3000 |
| 1.26–1.37 | 3300 |
| 1.38–1.51 | 3600 |
| 1.52–1.65 | 4000 |
| 1.66–1.77 | 4300 |
| 1.78–1.91 | 4600 |
| 1.92–2.05 | 5000 |
| 2.06–2.17 | 5300 |
| ≥2.18 | 5600 |
| Divide into 2 equal doses given morning and evening. |
Generic Name: capecitabine
An antimetabolite - treats Breast Cancer and Colorectal Cancer
FDA Alerts-
-
Alterations in Anticoagulant Effects
- Altered coagulation parameters (e.g., increased PT, increased INR) and/or bleeding, sometimes fatal, reported in patients, with or without liver metastases, receiving capecitabine concomitantly with coumarin-derivative anticoagulants. Generally occurs within several days to months following initiation of therapy, but has been reported within 1 month following discontinuance of therapy. (See Coagulopathy under Cautions and also see Specific Drugs under Interactions.)
- Age >60 years and diagnosis of cancer may independently increase risk of coagulopathy.
- Monitor anticoagulant response (PT or INR) frequently in patients receiving concomitant capecitabine and oral coumarin-derivative therapy; adjust anticoagulant dosage accordingly.
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- Basic Info
- Top Questions
- Clinical Info
- Interactions
Uses
Breast Cancer
Treatment of metastatic breast cancer in combination with docetaxel in patients with disease that failed to respond to, or recurred or relapsed during or following, anthracycline-containing chemotherapy.
Synergistic effect with combination therapy; docetaxel increases the expression of an enzyme found at higher concentrations in many tumor cells that is involved in converting capecitabine to its active moiety, fluorouracil.
Palliative treatment of metastatic breast cancer, as monotherapy, in patients with disease resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or in patients with disease resistant to paclitaxel who are not candidates for further anthracycline therapy (e.g., cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents).
Colorectal Cancer
Used alone as adjuvant therapy following the complete resection of primary tumor in patients with stage III (Dukes’ C) colon cancer when treatment with fluoropyrimidine therapy alone is preferred. May be used as an alternative to fluorouracil/leucovorin when single-agent therapy is desired for convenience or lesser toxicity.
Initial (first-line) treatment of metastatic colorectal cancer when fluoropyrimidine therapy alone is preferred.
Gastric Cancer
Being investigated for use in combination regimens for advanced gastric cancer†.
Dosage and Administration
Administration
Oral Administration
Administer orally with water twice daily within 30 minutes after the end of a meal, in the morning and evening.
If administered concomitantly with docetaxel, patients should be premedicated prior to docetaxel administration. Consult docetaxel manufacturer's labeling for specific information.
Dosage
Adults
Breast Cancer
Combination Therapy
Oral
Initially, 1250 mg/m2 twice daily (2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period; courses of therapy are given in 3-week cycles. (See Table 1.)
Treatment was continued for at least 6 weeks in a clinical trial.
Consult published protocols for dosages in combination regimens and methods and sequence of administration.
After the initial dose, modify subsequent doses as necessary based on individual patient tolerance with careful monitoring to obtain optimal therapeutic response with minimal toxicity. (See Table 2.)
Monotherapy
Oral
Initially, 1250 mg/m2 twice daily (2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period; courses of therapy are given in 3-week cycles. (See Table 1.)
Some experts suggest that a trial of 2 cycles (i.e., 6 weeks) of therapy is adequate to assess response. During a clinical trial, onset of response typically occurred within 6–12 weeks.
After the initial dose, modify subsequent doses as necessary based on individual patient tolerance with careful monitoring to obtain optimal therapeutic response with minimal toxicity. (See Table 3.)
Colorectal Cancer
Adjuvant Therapy for Colon Cancer
Oral
Initially, 1250 mg/m2 twice daily (2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period; courses of therapy are given in 3-week cycles for a total of 8 cycles and a treatment period of 6 months. (See Table 1.)
After the initial dose, modify subsequent doses as necessary based on individual patient tolerance with careful monitoring to obtain optimal therapeutic response with minimal toxicity. (See Table 3.)
First-line Therapy for Metastatic Colorectal Cancer
Oral
Initially, 1250 mg/m2 twice daily (2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period; courses of therapy are given in 3-week cycles. (See Table 1.)
After the initial dose, modify subsequent doses as necessary based on individual patient tolerance with careful monitoring to obtain optimal therapeutic response with minimal toxicity. (See Table 3.)
Other Dosage Considerations
Recommended Initial Dosage
Dosage Modification for Toxicity
Adjust doses according to the severity and recurrence of the toxicity. (See Table 2 and Table 3.)
When therapy is interrupted because of toxicity, resume according to planned treatment cycles; doses omitted because of toxicity should not be replaced. Once a dosage has been reduced for toxicity, it should not be increased at a later time.
If a patient experiences either no toxicity or NCIC grade 1 toxicity within a course of treatment, maintain the current dose for subsequent courses of therapy until more serious toxicity occurs.
| NCIC Toxicity Grade | Number of Appearances | Comments |
|---|---|---|
| Grade 2 | 1st appearance |
Interrupt therapy until resolved to grade 0–1, then resume at 100% of the original capecitabine dose; do not replace missed doses If toxicity persists when the next course of therapy is due, delay therapy until toxicity resolved to grade 0–1, then resume therapy at 100% of the original capecitabine and docetaxel doses |
| 2nd appearance |
Interrupt therapy until resolved to grade 0–1, then resume at 75% of the original capecitabine dose; do not replace missed doses If toxicity persists when the next course of therapy is due, delay therapy until resolved to grade 0–1, then resume therapy at 75% of the original capecitabine dose and at 55 mg/m2 of docetaxel | |
| 3rd appearance |
Interrupt therapy until resolved to grade 0–1, then resume at 50% of the original capecitabine dose; do not replace missed doses If toxicity persists when the next course of therapy is due, delay therapy until resolved to grade 0–1, then resume therapy at 50% of the original capecitabine dose and discontinue docetaxel | |
| 4th appearance | Discontinue therapy permanently | |
| Grade 3 | 1st appearance |
Interrupt therapy until resolved to grade 0–1, then resume at 75% of the original capecitabine dose; do not replace missed doses If toxicity persists when the next course of therapy is due, delay therapy until toxicity resolved to grade 0–1, then resume therapy at 75% of the original capecitabine dose and at 55 mg/m2 of docetaxel |
| 2nd appearance |
Interrupt therapy until resolved to grade 0–1 and then resume at 50% of the original capecitabine dose; do not replace missed doses If toxicity persists when the next course of therapy is due, delay therapy until resolved to grade 0–1, then resume therapy at 50% of the original capecitabine dose and discontinue docetaxel | |
| 3rd appearance | Discontinue therapy permanently | |
| Grade 4 | 1st appearance |
Discontinue therapy permanently Or If deemed in best interest of patient to continue therapy, interrupt therapy until resolved to grade 0–1, then resume therapy at 50% of the original dose of capecitabine |
| 2nd appearance | Discontinue therapy permanently | |
|
Prophylaxis for toxicity should be instituted whenever possible; all dosage modifications should be based on the worst preceding toxicity. NCIC Common Toxicity Criteria except for hand-foot syndrome, which is defined according to a grading system incorporated by Roche and accepted by FDA. |
| NCIC Grade of Toxicity | Number of Appearances | During a Course of Therapy | Dose Adjustment for Next Cycle (% of Initial Dose) |
|---|---|---|---|
| Grade 2 | 1st appearance | Interrupt therapy until resolved to grade 0–1 | 100% |
| 2nd appearance | Interrupt therapy until resolved to grade 0–1 | 75% | |
| 3rd appearance | Interrupt therapy until resolved to grade 0–1 | 50% | |
| 4th appearance | Discontinue therapy permanently | ||
| Grade 3 | 1st appearance | Interrupt therapy until resolved to grade 0–1 | 75% |
| 2nd appearance | Interrupt therapy until resolved to grade 0–1 | 50% | |
| 3rd appearance | Discontinue therapy permanently | ||
| Grade 4 | 1st appearance | Discontinue therapy permanently | |
| or | |||
| If deemed in best interest of patient to continue therapy, interrupt therapy until resolved to grade 0–1 | 50% | ||
|
All dose modifications should be based on the worst preceding toxicity. NCIC Common Toxicity Criteria except for hand-foot syndrome, which is defined according to a grading system incorporated by Roche and accepted by FDA. |
Special Populations
Dosage in Hepatic Impairment
No initial dosage adjustment necessary in patients with mild to moderate hepatic dysfunction secondary to liver metastases. Use with caution; monitor patients carefully during therapy.
Dosage in Renal Impairment
Contraindicated in patients with severe renal impairment (Clcr <30 mL/minute).
In patients with moderate renal impairment (Clcr 30–50 mL/minute), reduce dosage (as monotherapy or in combination with docetaxel) by 25% of the initial dose (i.e., from 1250 to 950 mg/m2 twice daily).
No adjustment in starting dose recommended in patients with mild renal impairment.
Monitor carefully in patients with mild or moderate renal impairment because the frequency and/or severity of adverse effects may be increased. Discontinue treatment promptly if the patient develops a grade 2, 3, or 4 adverse effect; modify dosage for toxicity. (See Table 2 and Table 3.)
Geriatric Patients
Manufacturer states that insufficient data are available to recommend dosage adjustment for age in geriatric patients; however, the greater frequency of decreased hepatic and/or renal function in the elderly should be considered.
Patients >80 years of age receiving monotherapy: Some experts recommend dosage reduction (e.g., reduce initial dosage by up to 20%). (See Geriatric Use under Cautions.)
Patients >60 years of age receiving capecitabine/docetaxel combination: Some experts recommend dosage reduction (reduce initial dose by 25% [to 950 mg/m2]). (See Geriatric Use under Cautions.)
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