capecitabine

ROUTE	ONSET	PEAK	DURATION
PO	unknown‡	1.5 hr (2 hr for 5-fluorouracil)‡	unknown

Colorectal Cancer

Adjuvant Treatment of Colon Cancer
PO (Adults ): Monotherapy: 1250 mg/m² twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles. In combination with oxaliplatin: 1000 mg/m² twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.
Perioperative Treatment of Rectal Cancer
PO (Adults ): Without concurrent radiation: 1250 mg/m² twice daily. With concurrent radiation: 825 mg/m² twice daily.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.
Unresectable or Metastatic Colorectal Cancer
PO (Adults ): Monotherapy: 1250 mg/m² twice daily for the first 14 days of each 21-day cycle; continue until disease progression or unacceptable toxicity. In combination with oxaliplatin: 1000 mg/m² twice daily for the first 14 days of each 21-day cycle; continue until disease progression or unacceptable toxicity.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.

Advanced or Metastatic Breast Cancer

PO (Adults ): Monotherapy or in combination with docetaxel: 1000 mg/m² or 1250 mg/m² twice daily for the first 14 days of each 21-day cycle; continue until disease progression or unacceptable toxicity.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.

Gastric, Esophageal, or Gastroesophageal Junction Cancer

Unresectable or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Cancer
PO (Adults ): 625 mg/m² twice daily on Days 1–21 of each 21-day cycle for a maximum of 8 cycles (in combination with platinum-containing chemotherapy) OR 850 mg/m² or 1000 mg/m² twice daily for the first 14 days of each 21-day cycle (in combination with oxaliplatin); continue until disease progression or unacceptable toxicity.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.
HER-2 Overexpressing Metastatic Gastric or Gastroesophageal Junction Cancer
PO (Adults ): In combination with cisplatin and trastuzumab: 1000 mg/m² twice daily for the first 14 days of each 21-day cycle; continue until disease progression or unacceptable toxicity.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.

Pancreatic Cancer

PO (Adults ): In combination with gemcitabine: 830 mg/m² twice daily for the first 21 days of each 28-day cycle; continue until disease progression, unacceptable toxicity, or a maximum of 6 cycles.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: ↓initial dose by 25%.

Availability ⬆ ⬇

(Generic available)

Tablets: 150 mg; 500 mg

Assessment ⬆ ⬇

Assess for signs of infection (fever, chills, sore throat, cough, hoarseness, pain in lower back or side, difficult or painful urination). Assess for bleeding (bleeding gums; bruising; petechiae; guaiac-test stools, urine, and emesis). Avoid IM injections and taking rectal temperatures. Apply pressure to venipuncture sites for 10 min. Anemia may occur. Monitor for ↑ fatigue, dyspnea, and orthostatic hypotension.
Assess mucous membranes, number and consistency of stools, and frequency of vomiting. Notify health care provider if symptoms of toxicity (stomatitis, uncontrollable vomiting, diarrhea, fever) occur; drug may need to be discontinued or dose ↓. Patients with severe diarrhea should be monitored carefully, administered antidiarrheal agents (loperamide), and given fluid and electrolyte replacements if they become dehydrated. If grade 2, 3, or 4 diarrhea occurs, immediately stop therapy until diarrhea resolves or ↓ in intensity to Grade 1. Grade 3 or 4 diarrhea usually lasts 5 days.
Assess patient for mucocutaneous and dermatologic toxicity (Stevens-Johnson syndrome, toxic epidermal necrolysis, hand-and-foot syndrome). If Grade 2 or 3 toxicity occurs, interrupt therapy until Grade 1. ↓ doses following Grade 3.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy. Consider testing for genetic variants of dihydropyrimidine dehydrogenase deficiency prior to initiating therapy to ↓ risk of serious adverse reactions. Serious adverse reactions may still occur even if no dihydropyrimidine dehydrogenase deficiency variants are identified. An FDA-authorized test for the detection of genetic variants of dihydropyrimidine dehydrogenase deficiency to identify patients at risk of serious adverse reactions due to ↑ systemic exposure to capecitabine is not currently available. Currently available tests used to identify dihydropyrimidine dehydrogenase deficiency variants may vary in accuracy and design.
- Monitor CBC at baseline and before each cycle. May cause leukopenia, anemia, and thrombocytopenia. If baseline neutrophil count <1.5 × 10⁹ /L or platelet count <100 × 10⁹ /L, therapy is not recommended. For grade 3–4 myelosuppression, hold dose and then resume at same or ↓ dose, or permanently discontinue capecitabine, based on occurrence.
- Monitor hepatic (serum alkaline phosphatase, AST, ALT, and bilirubin), and renal function before and periodically during therapy. Therapy should be interrupted if serum bilirubin ↑ to 1.5 times normal or greater; may be reinstituted after bilirubin returns to normal.
- Monitor INR frequently in patients receiving warfarin and capecitabine to adjust warfarin dose. May cause ↑ bleeding within a few days to several months of initiation of therapy to 1 mo following discontinuation of therapy. Risk is greater in patients >60 yr.

Implementation ⬆ ⬇

High Alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double-check single, daily, and course-of-therapy dose limits; have second practitioner independently double-check original order and dose calculations.
Dose modifications are based on degree of toxicity encountered. If Grade 2 adverse reaction occurs, hold dose until resolved to Grade ≤1. If adverse reaction recurs,↓ dose by 75%. If Grade 2 reaction occurs a 3rd time, ↓dose by 50%. If reaction occurs a 4th time, permanently discontinue capecitabine. If Grade 3 adverse reaction occurs, hold dose until resolved to grade ≤1 and ↓ dose by 75%. If Grade 3 reaction recurs,↓ dose by 50%. If Grade 3 reaction occurs a 3rd time, permanently discontinue capecitabine. If Grade 4 adverse reaction occurs, permanently discontinue or hold dose until resolved to grade ≤1; then ↓ dose by 50%. Once a dose has been ↓ because of toxicity, do not ↑ at a later time.
PO: Administer every 12 hr for 2 wk, followed by a 1-wk rest period. Take tablets with water within 30 min after a meal. DNC: Swallow tablets whole; do not crush or cut. Capecitabine is a hazardous drug. Exposure to crushed tablets may cause eye irritation and swelling, skin rash, diarrhea, paresthesia, headache, gastric irritation, vomiting, and nausea.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication every 12 hr with water within 30 min after a meal. Missed doses should be omitted; continue regular schedule. If vomiting occurs, omit dose. Do not double dose. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
Inform patient of the most common side effects. Instruct patient to notify health care provider immediately if any of the following occur: diarrhea (>4 bowel movements in a day or any diarrhea at night), vomiting (more than once in 24 hr), nausea (loss of appetite and significant decrease in daily food intake), stomatitis (pain, redness, swelling, or sore in mouth), hand-and-foot syndrome (pain, swelling, or redness of hands and/or feet), skin reactions (rash, blisters, peeling of skin), fever, or infection (temperature of ≥100.5° F or other signs of infection).
Instruct patient to notify health care provider if fever; chills; sore throat; signs of infection; yellowing of skin or eyes; abdominal pain; joint or flank pain; swelling of feet or legs; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patients should be cautioned not to drink alcoholic beverages or take products containing aspirin or NSAIDs.
- Advise patient to rinse mouth with clear water after eating and drinking and to avoid flossing to minimize stomatitis. Viscous lidocaine may be used if mouth pain interferes with eating. Stomatitis pain may require treatment with opioid analgesics.
- Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
- Advise women of reproductive potential to use effective contraception during and for ≥6 mo after last dose. Advise men with female partners of reproductive potential to use effective contraception for ≥3 mo after last dose. Avoid breastfeeding during and for 1 wk after last dose. May impair fertility.
- Emphasize the importance of routine follow-up lab tests to monitor progress and to check for side effects.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased spread of colorectal, breast, gastric, esophageal, gastroesophageal junction, and pancreatic cancer.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-7473- Capecitabine
  - 0093-7473-06- 60 TABLET, FILM COATED in 1 BOTTLE (0093-7473-06)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-7474- Capecitabine
  - 0093-7474-89- 120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89)

15308- Aarti Pharmalabs Limited
- 15308-0714-
  - 15308-0714-0- 25 kg in 1 DRUM (15308-0714-0)

16714- NORTHSTAR RXLLC
- 16714-467- CAPECITABINE
  - 16714-467-01- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-467-01)

16714- NORTHSTAR RXLLC
- 16714-468- CAPECITABINE
  - 16714-468-01- 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-468-01)

16729- Accord Healthcare Inc.
- 16729-072- CAPECITABINE
  - 16729-072-12- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-072-12)

16729- Accord Healthcare Inc.
- 16729-073- CAPECITABINE
  - 16729-073-29- 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-073-29)

31722- Camber Pharmaceuticals, Inc.
- 31722-774- capecitabine
  - 31722-774-60- 60 TABLET, FILM COATED in 1 BOTTLE (31722-774-60)

31722- Camber Pharmaceuticals, Inc.
- 31722-775- capecitabine
  - 31722-775-12- 120 TABLET, FILM COATED in 1 BOTTLE (31722-775-12)

31722- Camber Pharmaceuticals, Inc.
- 31722-775- capecitabine
  - 31722-775-60- 60 TABLET, FILM COATED in 1 BOTTLE (31722-775-60)

35369- Shandong Anxin Pharmaceutical Co., Ltd.
- 35369-0010-
  - 35369-0010-1- 5 kg in 1 CANISTER (35369-0010-1)

35369- Shandong Anxin Pharmaceutical Co., Ltd.
- 35369-0010-
  - 35369-0010-2- 25 kg in 1 DRUM (35369-0010-2)

49452- Spectrum Laboratory Products, Inc.
- 49452-1713-
  49452-1713-1- 500 g in 1 CONTAINER (49452-1713-1)

49452- Spectrum Laboratory Products, Inc.
- 49452-1713-
  49452-1713-2- 1000 g in 1 CONTAINER (49452-1713-2)

51407- Golden State Medical Supply, Inc.
- 51407-639- Capecitabine
  51407-639-60- 60 TABLET, FILM COATED in 1 BOTTLE (51407-639-60)

51407- Golden State Medical Supply, Inc.
- 51407-640- Capecitabine
  - 51407-640-12- 120 TABLET, FILM COATED in 1 BOTTLE (51407-640-12)

53183- Sicor S.r.l.
- 53183-4009-
  - 53183-4009-1- 1 kg in 1 CARTON (53183-4009-1)

54245- SciAnda (Changshu) Pharmaceuticals, Ltd.
- 54245-7014-
  54245-7014-0- 30 kg in 1 BAG (54245-7014-0)

54893- MSN Laboratories Private Limited
- 54893-0002-
  54893-0002-1- 50 kg in 1 DRUM (54893-0002-1)

55111- Dr. Reddy's Laboratories Limited
- 55111-496- capecitabine
  55111-496-05- 500 TABLET in 1 BOTTLE (55111-496-05)

55111- Dr. Reddy's Laboratories Limited
- 55111-496- capecitabine
  - 55111-496-60- 60 TABLET in 1 BOTTLE (55111-496-60)

55111- Dr. Reddy's Laboratories Limited
- 55111-497- capecitabine
  - 55111-497-04- 120 TABLET in 1 BOTTLE (55111-497-04)

55111- Dr. Reddy's Laboratories Limited
- 55111-497- capecitabine
  - 55111-497-05- 500 TABLET in 1 BOTTLE (55111-497-05)

55111- Dr. Reddy's Laboratories Limited
- 55111-893-
  - 55111-893-00- 1 kg in 1 DRUM (55111-893-00)

55512- Archimica S.p.A.
- 55512-0015-
  55512-0015-0- 20 kg in 1 DRUM (55512-0015-0)

59651- Aurobindo Pharma Limited
- 59651-204- Capecitabine
  59651-204-10- 1 BLISTER PACK in 1 CARTON (59651-204-10) / 10 TABLET in 1 BLISTER PACK

59651- Aurobindo Pharma Limited
- 59651-204- Capecitabine
  - 59651-204-60- 60 TABLET in 1 BOTTLE (59651-204-60)

59651- Aurobindo Pharma Limited
- 59651-205- Capecitabine
  - 59651-205-08- 120 TABLET in 1 BOTTLE (59651-205-08)

59651- Aurobindo Pharma Limited
- 59651-205- Capecitabine
  - 59651-205-10- 1 BLISTER PACK in 1 CARTON (59651-205-10) / 10 TABLET in 1 BLISTER PACK

59923- Areva Pharmaceuticals
- 59923-721- Capecitabine
  - 59923-721-60- 60 TABLET, FILM COATED in 1 BOTTLE (59923-721-60)

60687- American Health Packaging
- 60687-149- Capecitabine
  - 60687-149-94- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-149-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-149-11)

61269- H2-Pharma, LLC
- 61269-470- Xeloda
  - 61269-470-60- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-470-60)

61269- H2-Pharma, LLC
- 61269-475- Xeloda
  - 61269-475-12- 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)

62331- Divi's Laboratories Limited
- 62331-043-
  - 62331-043-31- 50 kg in 1 DRUM (62331-043-31)

62756- Sun Pharmaceutical Industries, Inc.
- 62756-238- Capecitabine
  62756-238-18- 1000 TABLET, FILM COATED in 1 BOTTLE (62756-238-18)

62756- Sun Pharmaceutical Industries, Inc.
- 62756-238- Capecitabine
  - 62756-238-86- 60 TABLET, FILM COATED in 1 BOTTLE (62756-238-86)

62756- Sun Pharmaceutical Industries, Inc.
- 62756-238- Capecitabine
  - 62756-238-88- 100 TABLET, FILM COATED in 1 BOTTLE (62756-238-88)

62756- Sun Pharmaceutical Industries, Inc.
- 62756-239- Capecitabine
  - 62756-239-18- 1000 TABLET, FILM COATED in 1 BOTTLE (62756-239-18)

62756- Sun Pharmaceutical Industries, Inc.
- 62756-239- Capecitabine
  - 62756-239-20- 120 TABLET, FILM COATED in 1 BOTTLE (62756-239-20)

62756- Sun Pharmaceutical Industries, Inc.
- 62756-239- Capecitabine
  - 62756-239-83- 30 TABLET, FILM COATED in 1 BOTTLE (62756-239-83)

65129- ScinoPharm Taiwan Ltd.
- 65129-1241-
  - 65129-1241-0- 30 kg in 1 DRUM (65129-1241-0)

67877- Ascend Laboratories, LLC
- 67877-458- Capecitabine
  67877-458-12- 120 TABLET, FILM COATED in 1 BOTTLE (67877-458-12)

67877- Ascend Laboratories, LLC
- 67877-458- Capecitabine
  - 67877-458-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-458-30)

67877- Ascend Laboratories, LLC
- 67877-458- Capecitabine
  - 67877-458-60- 60 TABLET, FILM COATED in 1 BOTTLE (67877-458-60)

67877- Ascend Laboratories, LLC
- 67877-459- Capecitabine
  - 67877-459-12- 120 TABLET, FILM COATED in 1 BOTTLE (67877-459-12)

67877- Ascend Laboratories, LLC
- 67877-459- Capecitabine
  - 67877-459-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-459-30)

67877- Ascend Laboratories, LLC
- 67877-459- Capecitabine
  - 67877-459-60- 60 TABLET, FILM COATED in 1 BOTTLE (67877-459-60)

68001- BluePoint Laboratories
- 68001-487- CAPECITABINE
  - 68001-487-06- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-487-06)

68001- BluePoint Laboratories
- 68001-488- CAPECITABINE
  - 68001-488-07- 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-488-07)

68001- BluePoint Laboratories
- 68001-643- capecitabine
  - 68001-643-06- 60 TABLET, FILM COATED in 1 BOTTLE (68001-643-06)

68001- BluePoint Laboratories
- 68001-644- capecitabine
  - 68001-644-07- 120 TABLET, FILM COATED in 1 BOTTLE (68001-644-07)

68554- Hetero Labs Limited
- 68554-0033-
  - 68554-0033-1- 20 kg in 1 DRUM (68554-0033-1)

69097- Cipla USA Inc.
- 69097-948- Capecitabine
  69097-948-08- 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08)

69097- Cipla USA Inc.
- 69097-949- Capecitabine
  - 69097-949-03- 60 TABLET, FILM COATED in 1 BOTTLE (69097-949-03)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-019- Capecitabine
  - 69539-019-60- 60 TABLET, FILM COATED in 1 BOTTLE (69539-019-60)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-019- Capecitabine
  - 69539-019-99- 1000 TABLET, FILM COATED in 1 BOTTLE (69539-019-99)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-020- Capecitabine
  - 69539-020-92- 120 TABLET, FILM COATED in 1 BOTTLE (69539-020-92)

69539- MSN LABORATORIES PRIVATE LIMITED
- 69539-020- Capecitabine
  - 69539-020-99- 1000 TABLET, FILM COATED in 1 BOTTLE (69539-020-99)

70756- Lifestar Pharma LLC
- 70756-815- Capecitabine
  - 70756-815-60- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70756-815-60)

70756- Lifestar Pharma LLC
- 70756-816- Capecitabine
  - 70756-816-22- 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70756-816-22)

71901- EMNAR PHARMA PRIVATE LIMITED
- 71901-628-
  - 71901-628-01- 25 kg in 1 DRUM (71901-628-01)

72205- Novadoz Pharmaceuticals LLC
- 72205-006- Capecitabine
  72205-006-60- 60 TABLET, FILM COATED in 1 BOTTLE (72205-006-60)

72205- Novadoz Pharmaceuticals LLC
- 72205-007- Capecitabine
  - 72205-007-92- 120 TABLET, FILM COATED in 1 BOTTLE (72205-007-92)

72485- Armas Pharmaceuticals Inc.
- 72485-204- Capecitabine 150mg
  - 72485-204-60- 1 BOTTLE in 1 CARTON (72485-204-60) / 60 TABLET, FILM COATED in 1 BOTTLE

72485- Armas Pharmaceuticals Inc.
- 72485-205- Capecitabine 500mg
  - 72485-205-12- 1 BOTTLE in 1 CARTON (72485-205-12) / 120 TABLET, FILM COATED in 1 BOTTLE

72603- NorthStar RxLLC
- 72603-303- capecitabine
  - 72603-303-01- 120 TABLET, FILM COATED in 1 BOTTLE (72603-303-01)

81955- Valary Lab Private Limited
- 81955-0001-
  - 81955-0001-1- 1 kg in 1 DRUM (81955-0001-1)

81955- Valary Lab Private Limited
- 81955-0001-
  81955-0001-2- 5 kg in 1 DRUM (81955-0001-2)

81955- Valary Lab Private Limited
- 81955-0001-
  81955-0001-3- 10 kg in 1 DRUM (81955-0001-3)

82009- Quallent Pharmaceuticals Health LLC
- 82009-112- Capecitabine
  82009-112-12- 120 TABLET in 1 BOTTLE (82009-112-12)

82249- CivicaScript LLC
- 82249-207- Capecitabine
  - 82249-207-60- 60 TABLET, FILM COATED in 1 BOTTLE (82249-207-60)

82249- CivicaScript LLC
- 82249-210- Capecitabine
  - 82249-210-12- 120 TABLET, FILM COATED in 1 BOTTLE (82249-210-12)

82511- Teyro Labs Private Limited
- 82511-001- Capecitabine
  - 82511-001-15- 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-001-15)

82511- Teyro Labs Private Limited
- 82511-002- Capecitabine
  - 82511-002-50- 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82511-002-50)

82920- SHILPA PHARMA LIFESCIENCES LIMITED
- 82920-001-
  - 82920-001-00- 25 kg in 1 DRUM (82920-001-00)

83774- Pilnova Pharma Inc
- 83774-100- Capecitabine
  83774-100-60- 60 TABLET, FILM COATED in 1 BOTTLE (83774-100-60)

83774- Pilnova Pharma Inc
- 83774-101- Capecitabine
  - 83774-101-12- 120 TABLET, FILM COATED in 1 BOTTLE (83774-101-12)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆