Capecitabine

Capecitabine Manufacturers

• Avkare, Inc.
  

  ×

  Capecitabine | Avkare, Inc.

  

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  Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Do not crush or cut capecitabine tablets. Capecitabine tablets dose is calculated according to body surface area.

  2.1 Standard Starting Dose

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

  The recommended dose of capecitabine tablets is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 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 [i.e., capecitabine tablets 1250 mg/m2 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: Capecitabine Tablets Dose Calculation According to Body Surface Area * Total Daily Dose divided by 2 to allow equal morning and evening doses

  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 to 1.37

  3300

  1

  3

  1.38 to 1.51

  3600

  2

  3

  1.52 to 1.65

  4000

  0

  4

  1.66 to 1.77

  4300

  1

  4

  1.78 to 1.91

  4600

  2

  4

  1.92 to 2.05

  5000

  0

  5

  2.06 to 2.17

  5300

  1

  5

  ≥ 2.18

  5600

  2

  5

  In Combination With Docetaxel (Metastatic Breast Cancer)

  In combination with docetaxel, the recommended dose of capecitabine tablets are 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 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 capecitabine tablets plus docetaxel combination. Table 1 displays the total daily dose of capecitabine tablets by body surface area and the number of tablets to be taken at each dose.

  2.2 Dose Management Guidelines

  General

  Capecitabine tablets dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to capecitabine tablet administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine tablets dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine tablets 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 capecitabine tablets [see Drug Interactions (7.1)].

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

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

  Table 2: Recommended Dose Modifications of Capecitabine Tablets * National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [ see Warnings and Precautions (5)].

  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 to 1

  100%

  -2nd appearance

  75%

  -3rd appearance

  50%

  -4th appearance

  Discontinue treatment permanently

  -

  Grade 3

  -1st appearance

  Interrupt until resolved to grade 0 to 1

  75%

  -2nd appearance

  50%

  -3rd appearance

  Discontinue treatment permanently

  -

  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 to 1

  50%

  In Combination With Docetaxel (Metastatic Breast Cancer)

  Dose modifications of capecitabine tablets for toxicity should be made according to Table 2 above for capecitabine tablets. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine tablets 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 capecitabine tablets for the treatment of metastatic breast cancer is shown in Table 3.

  Table 3: Docetaxel Dose Reduction Schedule in Combination with Capecitabine Tablets * National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [ see Warnings and Precautions (5)].

  Toxicity NCIC Grades*

  Grade 2

  Grade 3

  Grade 4

  1st appearance

  Delay treatment until resolved to grade 0 to 1; Resume treatment with original dose of 75 mg/m2 docetaxel

  Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel.

  Discontinue treatment with docetaxel

  2nd appearance

  Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel.

  Discontinue treatment with docetaxel

  -

  3rd appearance

  Discontinue treatment with docetaxel

  -

  -

  2.3 Adjustment of Starting Dose in Special Populations

  Renal Impairment

  No adjustment to the starting dose of capecitabine tablets 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 capecitabine tablets 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 (8.7) and Clinical Pharmacology (12.3)]. 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 (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine tablets monotherapy and capecitabine tablets in combination use with docetaxel.

  Cockroft and Gault Equation:

  (140 - age [yrs]) (body wt [kg])

  Creatinine clearance for males =

  —————————————

  (72) (serum creatinine [mg/dL])

   

   

  Creatinine clearance for females = 0.85 × male value

  
  Geriatrics

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

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• Teva Pharmaceuticals Usa Inc
  

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  Capecitabine | Remedyrepack Inc.

  

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  Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine extended release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7–14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended.

  Angina patients controlled on nifedipine immediate-release capsules alone or in combination with other antianginal medications may be safely switched to nifedipine extended release tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine immediate-release capsules may be changed to 90 mg once daily of nifedipine extended release tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted.

  Avoid co-administration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions).

  No "rebound effect" has been observed upon discontinuation of nifedipine extended release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

  Care should be taken when dispensing nifedipine extended release to assure that the extended release dosage form has been prescribed.

   

  Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS: Drug Interactions for information on co-administration of nifedipine with beta blockers or long-acting nitrates.

   

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• Kaiser Foundation Hospitals
  

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  Capecitabine | Kaiser Foundation Hospitals

  

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

  2.1 Standard Starting Dose

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

  The recommended dose of capecitabine tablets are 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles (seeTable 1).

  Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [i.e., capecitabine tablets 1250 mg/m2 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: Capecitabine Tablets Dose Calculation According to Body Surface Area * Total Daily Dose divided by 2 to allow equal morning and evening doses 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 to 1.37 3300 1 3 1.38 to 1.51 3600 2 3 1.52 to 1.65 4000 0 4 1.66 to 1.77 4300 1 4 1.78 to 1.91 4600 2 4 1.92 to 2.05 5000 0 5 2.06 to 2.17 5300 1 5 ≥ 2.18 5600 2 5

  In Combination With Docetaxel (Metastatic Breast Cancer)

  In combination with docetaxel, the recommended dose of capecitabine tablets are 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 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 capecitabine tablets plus docetaxel combination. Table 1 displays the total daily dose of capecitabine tablets by body surface area and the number of tablets to be taken at each dose.

  2.2 Dose Management Guidelines

  General

  Capecitabine tablets dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to capecitabine tablets administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine tablets dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine tablets 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 capecitabine tablets [see Drug Interactions (7.1)].

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

  Capecitabine tablets dose modification scheme as described below (seeTable 2) is recommended for the management of adverse reactions.

  Table 2: Recommended Dose Modifications of Capecitabine Tablets * National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [ see Warnings and Precautions (5)]. 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 to 1 100% -2nd appearance 75% -3rd appearance 50% -4th appearance Discontinue treatment permanently - Grade 3 -1st appearance Interrupt until resolved to grade 0 to 1 75% -2nd appearance 50% -3rd appearance Discontinue treatment permanently - 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 to 1 50%

  In Combination With Docetaxel (Metastatic Breast Cancer)

  Dose modifications of capecitabine tablets for toxicity should be made according to Table 2 above for capecitabine tablets. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine tablets 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 capecitabine tablets for the treatment of metastatic breast cancer is shown in Table 3.

  Table 3: Docetaxel Dose Reduction Schedule in Combination with Capecitabine Tablets * National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [ see Warnings and Precautions (5)]. Toxicity NCIC Grades* Grade 2 Grade 3 Grade 4 1st appearance Delay treatment until resolved to grade 0 to 1; Resume treatment with original dose of 75 mg/m2 docetaxel Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel. Discontinue treatment with docetaxel 2nd appearance Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel. Discontinue treatment with docetaxel - 3rd appearance Discontinue treatment with docetaxel - - 2.3 Adjustment of Starting Dose in Special Populations

  Renal Impairment

  No adjustment to the starting dose of capecitabine tablets 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 capecitabine tablets 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 (8.7) and Clinical Pharmacology (12.3)]. Subsequent dose adjustment is recommended as outlined in Table 2andTable 3 (depending on the regimen) if a patient develops a grade 2 to 4 adverse event [see Warnings and Precautions (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine tablets monotherapy and capecitabine tablets in combination use with docetaxel.

  Cockroft and Gault Equation: (140 - age [yrs]) (body wt [kg]) Creatinine clearance for males = ————————————— (72) (serum creatinine [mg/dL])     Creatinine clearance for females = 0.85 × male value

  Geriatrics

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

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• Mylan Pharmaceuticals Inc.
  

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  Capecitabine | Mylan Pharmaceuticals Inc.

  

  ---

  Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Do not crush or cut capecitabine tablets. Capecitabine dose is calculated according to body surface area.

  2.1 Standard Starting Dose Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

  The recommended dose of capecitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 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 [i.e., capecitabine 1250 mg/m2 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. Capecitabine Dose Calculation According to Body Surface Area * Total Daily Dose divided by two to allow equal morning and evening doses

  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 to 1.37

  3300

  1

  3

  1.38 to 1.51

  3600

  2

  3

  1.52 to 1.65

  4000

  0

  4

  1.66 to 1.77

  4300

  1

  4

  1.78 to 1.91

  4600

  2

  4

  1.92 to 2.05

  5000

  0

  5

  2.06 to 2.17

  5300

  1

  5

  ≥ 2.18

  5600

  2

  5

   

  In Combination With Docetaxel (Metastatic Breast Cancer)

  In combination with docetaxel, the recommended dose of capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 1 week rest period, combined with docetaxel at 75 mg/m2 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 capecitabine tablets plus docetaxel combination. Table  1  displays the total daily dose of capecitabine by body surface area and the number of tablets to be taken at each dose.

  2.2 Dose Management Guidelines General

  Capecitabine dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to capecitabine tablet administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine 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 capecitabine tablets [see Drug Interactions (7.1)].

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

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

  Table 2. Recommended Dose Modifications of Capecitabine * National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [see Warnings and Precautions (5)].

  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

  50%

  -3rd appearance

  Discontinue treatment permanently

  -

  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%

   

  In Combination with Docetaxel (Metastatic Breast Cancer)

  Dose modifications of capecitabine tablets for toxicity should be made according to Table 2  above for capecitabine. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine 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 capecitabine for the treatment of metastatic breast cancer is shown in Table 3.

  Table 3. Docetaxel Dose Reduction Schedule in Combination with Capecitabine * National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [see Warnings and Precautions (5)].

  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

  -

  -

   

  2.3 Adjustment of Starting Dose in Special Populations Renal Impairment

  No adjustment to the starting dose of capecitabine 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 capecitabine 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 (8.7) and Clinical Pharmacology (12.3)]. 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 (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine monotherapy and capecitabine in combination use with docetaxel.

  Cockroft and Gault Equation:

  Creatinine clearance for males =

  (140 – age [yrs]) (body wt [kg])

  (72) (serum creatinine [mg/dL])

  Creatinine clearance for females = 0.85 x male value

  Geriatrics

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

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• Mylan Institutional Inc.
  

  ×

  Capecitabine | Mylan Institutional Inc.

  

  ---

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

  2.1 Standard Starting Dose Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer)

  The recommended dose of capecitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 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 [i.e., capecitabine 1250 mg/m2 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. Capecitabine Dose Calculation According to Body Surface Area * Total Daily Dose divided by two to allow equal morning and evening doses

  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 to 1.37

  3300

  1

  3

  1.38 to 1.51

  3600

  2

  3

  1.52 to 1.65

  4000

  0

  4

  1.66 to 1.77

  4300

  1

  4

  1.78 to 1.91

  4600

  2

  4

  1.92 to 2.05

  5000

  0

  5

  2.06 to 2.17

  5300

  1

  5

  ≥ 2.18

  5600

  2

  5

   

  In Combination With Docetaxel (Metastatic Breast Cancer)

  In combination with docetaxel, the recommended dose of capecitabine is 1250 mg/m2 twice daily for 2 weeks followed by a 1 week rest period, combined with docetaxel at 75 mg/m2 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 capecitabine tablets plus docetaxel combination. Table  1  displays the total daily dose of capecitabine by body surface area and the number of tablets to be taken at each dose.

  2.2 Dose Management Guidelines General

  Capecitabine dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to capecitabine tablet administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine 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 capecitabine tablets [see Drug Interactions (7.1)].

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

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

  Table 2. Recommended Dose Modifications of Capecitabine * National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [see Warnings and Precautions (5)].

  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

  50%

  -3rd appearance

  Discontinue treatment permanently

  -

  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%

   

  In Combination with Docetaxel (Metastatic Breast Cancer)

  Dose modifications of capecitabine tablets for toxicity should be made according to Table 2  above for capecitabine. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine 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 capecitabine for the treatment of metastatic breast cancer is shown in Table 3.

  Table 3. Docetaxel Dose Reduction Schedule in Combination with Capecitabine * National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [see Warnings and Precautions (5)].

  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

  -

  -

   

  2.3 Adjustment of Starting Dose in Special Populations Renal Impairment

  No adjustment to the starting dose of capecitabine 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 capecitabine 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 (8.7) and Clinical Pharmacology (12.3)]. 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 (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine monotherapy and capecitabine in combination use with docetaxel.

  Cockroft and Gault Equation:

  Creatinine clearance for males =

  (140 –age [yrs]) (body wt [kg])

  (72) (serum creatinine [mg/dL])

  Creatinine clearance for females = 0.85 x male value

  Geriatrics

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

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• American Health Packaging
  

  ×

  Capecitabine | American Health Packaging

  

  ---

  Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Do not crush or cut capecitabine tablets. Capecitabine tablets dose is calculated according to body surface area.

  2.1 Standard Starting Dose

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

  The recommended dose of capecitabine tablets is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 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 [i.e., capecitabine tablets 1250 mg/m2 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: Capecitabine Tablets Dose Calculation According to Body Surface Area 1  Total Daily Dose divided by 2 to allow equal morning and evening doses

  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 Dose1 (mg)

  150 mg

  500 mg

  ≤ 1.25

  3000

  0

  3

  1.26 to 1.37

  3300

  1

  3

  1.38 to 1.51

  3600

  2

  3

  1.52 to 1.65

  4000

  0

  4

  1.66 to 1.77

  4300

  1

  4

  1.78 to 1.91

  4600

  2

  4

  1.92 to 2.05

  5000

  0

  5

  2.06 to 2.17

  5300

  1

  5

  ≥ 2.18

  5600

  2

  5

  In Combination With Docetaxel (Metastatic Breast Cancer)

  In combination with docetaxel, the recommended dose of capecitabine tablets are 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2 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 capecitabine tablets plus docetaxel combination. Table 1 displays the total daily dose of capecitabine tablets by body surface area and the number of tablets to be taken at each dose.

  2.2 Dose Management Guidelines

  General

  Capecitabine tablets dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)]. Toxicity due to capecitabine tablet administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine tablets dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine tablets 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 capecitabine tablets [see Drug Interactions (7.1)].

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

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

  Table 2: Recommended Dose Modifications of Capecitabine Tablets 1  National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [see Warnings and Precautions (5)].

  Toxicity NCIC Grades1

  
  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 to 1

  100%

  -2nd appearance

  75%

  -3rd appearance

  50%

  -4th appearance

  Discontinue treatment permanently

  -

  Grade 3

  -1st appearance

  Interrupt until resolved to grade 0 to 1

  75%

  -2nd appearance

  50%

  -3rd appearance

  Discontinue treatment permanently

  -

  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 to 1

  50%

  In Combination With Docetaxel (Metastatic Breast Cancer)

  Dose modifications of capecitabine tablets for toxicity should be made according to Table 2 above for capecitabine tablets. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine tablets 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 capecitabine tablets for the treatment of metastatic breast cancer is shown in Table 3.

  Table 3: Docetaxel Dose Reduction Schedule in Combination with Capecitabine Tablets 1  National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [see Warnings and Precautions (5)].

  Toxicity NCIC Grades1

  Grade 2

  Grade 3

  Grade 4

  1st appearance

  Delay treatment until resolved to grade 0 to 1; Resume treatment with original dose of 75 mg/m2 docetaxel

  Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel.

  Discontinue treatment with docetaxel

  2nd appearance

  Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m2 of docetaxel.

  Discontinue treatment with docetaxel

  -

  3rd appearance

  Discontinue treatment with docetaxel

  -

  -

  2.3 Adjustment of Starting Dose in Special Populations

  Renal Impairment

  No adjustment to the starting dose of capecitabine tablets 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 capecitabine tablets 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 (8.7) and Clinical Pharmacology (12.3)]. 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 (5.5)]. The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine tablets monotherapy and capecitabine tablets in combination use with docetaxel.

  Cockroft and Gault Equation:

  (140 - age [yrs]) (body wt [kg])

  Creatinine clearance for males =

  —————————————

  (72) (serum creatinine [mg/dL])

   

   

  Creatinine clearance for females = 0.85 × male value

  
  Geriatrics

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

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  Capecitabine | Northstar Rxllc

  

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  Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Do not crush or cut capecitabine tablets. Capecitabine tablets dose is calculated according to body surface area.

  2.1 Standard Starting Dose

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

  The recommended dose of capecitabine tablets are 1250 mg/m 2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m 2 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, capecitabine tablets 1250 mg/m 2 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 Capecitabine Tablets Dose Calculation According to Body Surface Area Dose Level 1250 mg/m 2
  Twice a Day Number of Tablets to be Taken at Each Dose (Morning and Evening) Surface Area (m 2) Total Daily Dose * (mg) 150 mg 500 mg * Total Daily Dose divided by 2 to allow equal morning and evening doses ≤ 1.25 3000 0 3 1.26 to 1.37 3300 1 3 1.38 to 1.51 3600 2 3 1.52 to 1.65 4000 0 4 1.66 to 1.77 4300 1 4 1.78 to 1.91 4600 2 4 1.92 to 2.05 5000 0 5 2.06 to 2.17 5300 1 5 ≥ 2.18 5600 2 5

  In Combination With Docetaxel (Metastatic Breast Cancer)

  In combination with docetaxel, the recommended dose of capecitabine tablets are 1250 mg/m 2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m 2 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 capecitabine tablets plus docetaxel combination. Table 1 displays the total daily dose of capecitabine tablets by body surface area and the number of tablets to be taken at each dose.

  2.2 Dose Management Guidelines

  General

  Capecitabine tablets dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14)] . Toxicity due to capecitabine tablets administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine tablets dose. Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine tablets 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 capecitabine tablets [see Drug Interactions (7.1)] .

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

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

  Table 2 Recommended Dose Modifications of Capecitabine Tablets Toxicity NCIC Grades *
  During a Course of Therapy Dose Adjustment for Next Treatment (% of starting dose) * National Cancer Institute of Canada Common Toxicity Criteria were used except for the hand-and-foot syndrome [see Warnings and Precautions (5)] . Grade 1 Maintain dose level Maintain dose level Grade 2 -1st appearance Interrupt until resolved to grade 0 to 1 100% -2nd appearance 75% -3rd appearance 50% -4th appearance Discontinue treatment permanently - Grade 3 -1st appearance Interrupt until resolved to grade 0 to 1 75% -2nd appearance 50% -3rd appearance Discontinue treatment permanently - 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 to 1 50%

  In Combination With Docetaxel (Metastatic Breast Cancer)

  Dose modifications of capecitabine tablets for toxicity should be made according to Table 2 above for capecitabine tablets. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine tablets 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 capecitabine tablets for the treatment of metastatic breast cancer is shown in Table 3.

  Table 3 Docetaxel Dose Reduction Schedule in Combination with Capecitabine Tablets Toxicity NCIC Grades * Grade 2 Grade 3 Grade 4 * National Cancer Institute of Canada Common Toxicity Criteria were used except for hand-and-foot syndrome [see Warnings and Precautions (5)] . 1st appearance Delay treatment until resolved to grade 0 to 1; Resume treatment with original dose of 75 mg/m 2 docetaxel Delay treatment until resolved to grade 0 to 1;
  Resume treatment at 55 mg/m2 of docetaxel. Discontinue treatment with docetaxel 2nd appearance Delay treatment until resolved to grade 0 to 1; Resume treatment at 55 mg/m 2 of docetaxel. Discontinue treatment with docetaxel - 3rd appearance Discontinue treatment with docetaxel - - 2.3 Adjustment of Starting Dose in Special Populations

  Renal Impairment

  No adjustment to the starting dose of capecitabine tablets are 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 capecitabine tablets starting dose when used as monotherapy or in combination with docetaxel (from 1250 mg/m 2 to 950 mg/m 2 twice daily) is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)] . 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 (5.5)] . The starting dose adjustment recommendations for patients with moderate renal impairment apply to both capecitabine tablets monotherapy and capecitabine tablets in combination use with docetaxel.

  Cockroft and Gault Equation: (140 - age [yrs]) (body wt [kg]) Creatinine clearance for males = ————————————— (72) (serum creatinine [mg/dL]) Creatinine clearance for females = 0.85 × male value

  Geriatrics

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

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