Capecitabine Dosage

Medically reviewed by Drugs.com. Last updated on May 27, 2024.

Applies to the following strengths: 150 mg; 500 mg

Usual Adult Dose for:

Colorectal Cancer
Breast Cancer
Esophageal Carcinoma
Gastric Cancer
Pancreatic Cancer

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Colorectal Cancer

ADJUVANT TREATMENT OF COLON CANCER:
As a Single Agent: 1250 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Duration of therapy: Maximum of 8 cycles

In Combination with Oxaliplatin-containing Regimens: 1000 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Administer with oxaliplatin 130 mg/m2 IV on Day 1 of each cycle
Duration of therapy: Maximum of 8 cycles

UNRESECTABLE OR METASTATIC COLORECTAL CANCER:
As a Single Agent: 1250 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Duration of therapy: Until disease progression or unacceptable toxicity

In Combination with Oxaliplatin-containing Regimens: 1000 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Administer with oxaliplatin 130 mg/m2 IV on Day 1 of each cycle
Duration of therapy: Until disease progression or unacceptable toxicity

PERIOPERATIVE TREATMENT OF RECTAL CANCER:

With Concomitant Radiation Therapy: 825 mg/m2 orally twice a day
WithOUT Radiation Therapy: 1250 mg/m2 orally twice a day

Comments:

Consult the manufacturer product information for any agents used in combination with this drug for additional information.

Uses:

As a single agent or as part of combination chemotherapy, for the adjuvant treatment of Stage III colon cancer
As a single agent or as part of combination chemotherapy, for the treatment of unresectable or metastatic colorectal cancer
As a component of chemoradiotherapy, for the perioperative treatment of locally advanced rectal cancer

Usual Adult Dose for Breast Cancer

ADVANCED OR METASTATIC BREAST CANCER:
As a Single Agent: 1000 mg/m2 OR 1250 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Individualize the dose and schedule based on patient risk factors and adverse reactions.
Duration of therapy: Until disease progression or unacceptable toxicity

In Combination with Docetaxel: 1000 mg/m2 OR 1250 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Administer with docetaxel 75 mg/m2 IV on Day 1 of each cycle.
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

Consult the manufacturer product information for any agents used in combination with this drug for additional information.

Uses:

As a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated, for the treatment of advanced or metastatic breast cancer
In combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy, for the treatment of advanced or metastatic breast cancer

Usual Adult Dose for Esophageal Carcinoma

UNRESECTABLE OR METASTATIC GASTRIC, ESOPHAGEAL, OR GASTROESOPHAGEAL JUNCTION CANCER:
In Combination with Platinum-containing Chemotherapy: 625 mg/m2 orally twice a day on Days 1 to 21 of each 21-day cycle

Duration of therapy: Maximum of 8 cycles

In Combination with Oxaliplatin-containing Regimens: 850 mg/m2 OR 1000 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Duration of therapy: Until disease progression or unacceptable toxicity
Administer with oxaliplatin 130 mg/m2 IV on Day 1 of each cycle
Individualize the dose and schedule based on patient risk factors and adverse reactions.

HER2-OVEREXPRESSING METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA:
In Combination with Cisplatin and Trastuzumab: 1000 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

Consult the manufacturer product information for any agents used in combination with this drug for additional information.

Uses:

As a component of a combination chemotherapy regimen, for the treatment of unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer
As a component of a combination regimen, for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease

Usual Adult Dose for Gastric Cancer

Duration of therapy: Maximum of 8 cycles

In Combination with Oxaliplatin-containing Regimens: 850 mg/m2 OR 1000 mg/m2 orally twice a day for the first 14 days of each 21 day cycle

Duration of therapy: Until disease progression or unacceptable toxicity
Administer with oxaliplatin 130 mg/m2 IV on Day 1 of each cycle
Individualize the dose and schedule based on patient risk factors and adverse reactions.

Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

Consult the manufacturer product information for any agents used in combination with this drug for additional information.

Uses:

As a component of a combination chemotherapy regimen, for the treatment of unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer
As a component of a combination regimen, for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease

Usual Adult Dose for Pancreatic Cancer

In Combination with Gemcitabine: 830 mg/m2 orally twice a day for the first 21 days of each 28-day cycle

Administer gemcitabine 1000 mg/m2 IV on Days 1, 8, and 15 of each cycle
Duration of therapy: Maximum of 6 cycles, or until disease progression or unacceptable toxicity

Comments:

Consult the manufacturer product information for any agents used in combination with this drug for additional information.

Use: As a component of a combination chemotherapy regimen, for the adjuvant treatment of pancreatic adenocarcinoma

Renal Dose Adjustments

Mild renal dysfunction (CrCl greater than 50 to 80 mL/min): Data not available
Moderate renal dysfunction (CrCl 30 to 50 mL/min): Reduce dose by 25%
Severe renal dysfunction (CrCl less than 30 mL/min): Unknown; dose has not been established

Comment:

This drug may be administered to patients with severe renal dysfunction on an individual basis if there is no alternative treatment available; it is recommended to initiate with a reduced starting dose, closely monitor, and modify the dose based on any observed adverse reaction(s).
Creatinine clearance should be calculated by the Cockcroft-Gault equation.

Liver Dose Adjustments

LIVER DYSFUNCTION: Data not available

GRADE 3 TO 4 HYPERBILIRUBINEMIA:

Withhold until resolved to grade 2 or less than 3 times the upper limit of normal.
Resume treatment at the percentage of dose recommended above for grade 3 or grade 4 severity.

Comments:

Monitor patients with liver dysfunction more frequently for adverse reactions.

Dose Adjustments

GENERAL RECOMMENDATIONS:

Monitor patients for adverse reactions and modify dosages as recommended.
Do not replace missed doses; instead, resume treatment with the next planned dosage.
When this drug is administered with docetaxel, withhold both this drug and docetaxel until the requirements for resuming this drug and docetaxel are met.
Consult the manufacturer product information for the agents used in combination with this drug for additional details if toxicity occurs.

DOSE ADJUSTMENT BASED ON SEVERITY:
Grade 2:

First appearance: Withhold until resolved to grade 1 or less; resume at 100% of the current dose.
Second appearance: Withhold until resolved to grade 1 or less; resume at 75% of the current dose.
Third appearance: Withhold until resolved to grade 1 or less; resume at 50% of the current dose.
Fourth appearance: Permanently discontinue treatment.

Grade 3:

First appearance: Withhold until resolved to grade 1 or less; resume at 75% of the current dose.
Second appearance: Withhold until resolved to grade 1 or less; resume at 50% of the current dose.
Third appearance: Permanently discontinue treatment.

Grade 4:

First appearance: Permanently discontinue treatment OR withhold until resolved to grade 1 or less; then, resume at 50% of the current dose.

Precautions

US BOXED WARNINGS:

ALTERED COAGULATION PARAMETERS: Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking this drug concomitantly with oral vitamin K antagonists, such as warfarin.
ELEVATED PROTHROMBIN TIME AND INR: Clinically significant increases in prothrombin time and INR have been reported in patients previously on stable doses of a vitamin K antagonist at the time of therapy initiation. These events occurred within several days and up to several months after initiating therapy and, in a few cases, within 1 month after stopping treatment. Events occurred in patients with and without liver metastases. Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate.

CONTRAINDICATIONS:

Known history of severe hypersensitivity to fluorouracil or capecitabine

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

For oral use
Round the recommended dosage to the nearest 150 mg to provide a whole tablet.
Administer tablets whole with water within 30 minutes after a meal.
Tablets should be taken at the same time each day approximately 12 hours apart.
Do not chew, cut, or crush tablets.
Missed dose: Do not take the missed dose; continue with the next scheduled dose.
Missed dose due to vomiting: Do not take an additional dose after vomiting; continue with the next scheduled dose.

Storage requirements:

Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

General:

This is a hazardous drug. Follow applicable special handling and disposal procedures.

Monitoring:

Dermatologic: For new or worsening serious skin reactions (during therapy)
Drug interactions: INR in patients taking a vitamin k antagonist (during therapy)
General: Testing for DPD deficiency/genetic variants of DPYD (prior to therapy)
Hematologic: Complete blood count (at baseline and before each treatment cycle)
Hepatic: For adverse reactions, especially in patients with hepatic impairment (during therapy)
Ocular: For adverse ophthalmic reactions, especially in patients with history of eye disorders (during therapy)
Renal: Renal function (at baseline and as clinically indicated)

Patient advice:

Read the US FDA-approved patient labeling (Patient Information) for additional information on adverse reactions and toxicities associated with treatment.
Understand that genetic testing may be required to determine risk of adverse reactions due to dihydropyrimidine dehydrogenase (DPD) deficiency.
Seek immediate medical attention if signs/symptoms of fever, skin rash/blistering, jaundice, decreased urination or dehydration, bloody diarrhea/abdominal pain, or difficulty swallowing/breathing.
Take this drug within 30 minutes after a meal and do not cut, crush, or chew tablets.
Patients of childbearing potential: Use effective during treatment; notify your health care provider of a known/suspected pregnancy.
Lactation patients: Breastfeeding is not recommended during treatment.