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Xeloda

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Xeloda

Xeloda

INDICATIONS

Colorectal Cancer

  • XELODA is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer.
  • XELODA is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with XELODA monotherapy. Use of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

Breast Cancer

  • XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
  • XELODA monotherapy is also 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/m 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.

DOSAGE AND ADMINISTRATION

XELODA tablets should be swallowed whole with water within 30 minutes after a meal. XELODA dose is calculated according to body surface area.

Standard Starting Dose

Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

The recommended dose of XELODA is 1250 mg/m administered orally twice daily (morning and evening; equivalent to 2500 mg/m total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles (see Table 1).

Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [ie, XELODA 1250 mg/m orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)].

Table 1 : XELODA Dose Calculation According to Body Surface Area

Dose Level 1250 mg/m²
Twice a Day
Number of Tablets to be Taken at Each Dose (Morning and Evening)
Surface Area (m²) Total Daily Dose* (mg) 150 mg 500 mg
≤ 1.25 3000 0 3
1.26-1.37 3300 1 3
1.38-1.51 3600 2 3
1.52-1.65 4000 0 4
1.66-1.77 4300 1 4
1.78-1.91 4600 2 4
1.92-2.05 5000 0 5
2.06-2.17 5300 1 5
≥ 2.18 5600 2 5
*Total Daily Dose divided by 2 to allow equal morning and evening doses

In Combination With Docetaxel (Metastatic Breast Cancer)

In combination with docetaxel, the recommended dose of XELODA is 1250 mg/m twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m as a 1-hour intravenous infusion every 3 weeks. Pre-medication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the XELODA plus docetaxel combination. Table 1 displays the total daily dose of XELODA by body surface area and the number of tablets to be taken at each dose.

Dose Management Guidelines

General

XELODA dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of XELODA should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies]. 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. Doses of XELODA omitted for toxicity are not replaced or restored; instead the patient should resume the planned treatment cycles.

The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly with XELODA [see DRUG INTERACTIONS].

Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

XELODA dose modification scheme as described below (see Table 2) is recommended for the management of adverse reactions.

Table 2 : Recommended Dose Modifications of XELODA

Toxicity NCIC Grades* During a Course of Therapy Dose Adjustment for Next Treatment (% 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 75%
-3rd appearance 50%
-4th appearance Discontinue treatment permanently -
Grade 3
-1st appearance Interrupt until resolved to grade 0-1 75%
-2nd appearance Discontinue treatment permanently 50%
-3rd appearance -
Grade 4
-1st 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 WARNINGS AND PRECAUTIONS].

In Combination With Docetaxel (Metastatic Breast Cancer)

Dose modifications of XELODA for toxicity should be made according to Table 2 above for XELODA. At the beginning of a treatment cycle, if a treatment delay is indicated for either XELODA or docetaxel, then administration of both agents should be delayed until the requirements for restarting both drugs are met.

The dose reduction schedule for docetaxel when used in combination with XELODA for the treatment of metastatic breast cancer is shown in Table 3.

Table 3 : Docetaxel Dose Reduction Schedule in Combination with XELODA

Toxicity NCIC Grades* Grade 2 Grade 3 Grade 4
1st appearance Delay treatment until resolved to grade 0-1; Resume treatment with original dose of 75 mg/m² docetaxel Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m² of docetaxel. Discontinue treatment with docetaxel
2nd appearance Delay treatment until resolved to grade 0-1; Resume treatment at 55 mg/m² of docetaxel. Discontinue treatment with docetaxel -
3rd appearance Discontinue treatment with docetaxel - -
*National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [see WARNINGS AND PRECAUTIONS].

Adjustment Of Starting Dose In Special Populations

Renal Impairment

No adjustment to the starting dose of XELODA is recommended in patients with mild renal impairment (creatinine clearance = 51 to 80 mL/min [Cockroft and Gault, as shown below]). In patients with moderate renal impairment (baseline creatinine clearance = 30 to 50 mL/min), a dose reduction to 75% of the XELODA starting dose when used as monotherapy or in combination with docetaxel (from 1250 mg/m² to 950 mg/m² twice daily) is recommended [see Use in Specific Populations and CLINICAL PHARMACOLOGY]. Subsequent dose adjustment is recommended as outlined in Table 2 and Table 3 (depending on the regimen) if a patient develops a grade 2 to 4 adverse event [see WARNINGS AND PRECAUTIONS]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both XELODA monotherapy and XELODA in combination use with docetaxel.

Cockroft and Gault Equation:

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)

Geriatrics

Physicians should exercise caution in monitoring the effects of XELODA in the elderly. Insufficient data are available to provide a dosage recommendation.

HOW SUPPLIED

Dosage Forms And Strengths

XELODA is supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg of capecitabine and each peach-colored tablet contains 500 mg of capecitabine.

150 mg

Color: Light peach

Engraving: XELODA on one side and 150 on the other

150 mg tablets are packaged in bottles of 60 (NDC 0004-1100-20).

500 mg

Color: Peach

Engraving: XELODA on one side and 500 on the other

500 mg tablets are packaged in bottles of 120 (NDC 0004-1101-50).

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.

Care should be exercised in the handling of XELODA. XELODA tablets should not be cut or crushed. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of tablets. If powder from broken XELODA tablets contacts the skin, wash the skin immediately and thoroughly with soap and water. If XELODA contacts the mucous membranes, flush thoroughly with water.

Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.1-4

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2. html

3. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am JHealth-Syst Pharm. 2006;63:1172-1193.

4. Polovich M., White JM, Kelleher LO (eds). Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.) 2005. Pittsburgh, PA: Oncology Nursing Society.

Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990. Revised: December 2013

Last reviewed on RxList: 12/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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