Brand name: Xeloda
Drug class: Antineoplastic Agents

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Antineoplastic agent; prodrug of fluorouracil (an antimetabolite).¹

Uses for Capecitabine

Breast Cancer

Used in combination with docetaxel for treatment of patients with advanced or metastatic breast cancer after disease progression on prior anthracycline-containing chemotherapy.^{1 37 12000}

Used for treatment of patients with advanced or metastatic breast cancer as monotherapy if an anthracycline- or taxane-containing chemotherapy is not indicated.^{1 15 12000}

Colorectal Cancer

Used as adjuvant treatment of patients with stage III colon cancer alone or as part of a combination chemotherapy regimen.^{1 42 47 10002 12003 12004}

Used as perioperative treatment for adults with locally advanced rectal cancer as part of a combination chemoradiotherapy regimen.^{1 12001}

Used for treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as part of a combination chemotherapy regimen.^{1 31 32 12002 12003 12004}

Gastric, Esophageal, or Gastroesophageal Junction Cancer

Used for treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as part of a combination chemotherapy regimen.^{1 44 12006 12007}

Used for treatment of adults with human epidermal growth factor receptor (HER)2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not been previously treated for metastatic disease as part of a combination chemotherapy regimen.^{1 12005}

Pancreatic Cancer

Used as adjuvant treatment of adults with pancreatic adenocarcinoma as part of a combination chemotherapy regimen.^{1 12008 12009}

Capecitabine Dosage and Administration

General

Pretreatment Screening

• Consider testing for genetic variants of dihydropyrimidine dehydrogenase (DPYD), the gene encoding dihydropyrimidine dehydrogenase (DPD), prior to initiating treatment with capecitabine.¹

• Obtain CBC at baseline.¹ Do not initiate capecitabine therapy if baseline neutrophil count <1500/mm³ and/ or baseline platelet count <100,000/mm³.¹

• Assess renal function and hydration status prior to initiating treatment with capecitabine.¹ Optimize hydration prior to initiating treatment.¹

• Verify pregnancy status in females of reproductive potential prior to initiating treatment with capecitabine.¹

Patient Monitoring

• Obtain CBC prior to each treatment cycle.¹

• Monitor renal function and hydration status as clinically indicated during treatment with capecitabine.¹ Promptly correct dehydration, which can develop rapidly in patients with anorexia, asthenia, nausea, vomiting, or diarrhea, and can result in acute renal failure; patients with preexisting renal impairment and those receiving concomitant therapy with nephrotoxic agents are at increased risk.¹

• Monitor for new or worsening serious skin reactions during treatment with capecitabine.¹

• If capecitabine is used in patients receiving a coumarin-derivative anticoagulant, PT or INR should be monitored frequently, and the anticoagulant dosage should be adjusted accordingly.¹

• Liver function should be monitored carefully during capecitabine therapy in patients with mild to moderate hepatic impairment.¹

Premedication and Prophylaxis

• If used concomitantly with docetaxel, administer premedication prior to docetaxel administration.¹ Consult docetaxel manufacturer’s labeling for specific information.¹

Dispensing and Administration Precautions

• Based on the Institute for Safe Medication Practices (ISMP), capecitabine is a high-alert medication that has a heightened risk of causing significant patient harm when used in error.⁷⁷²

Handling and Disposal

• Procedures for proper handling and disposal of antineoplastic drugs should be followed when preparing or administering capecitabine.¹

• Capecitabine should be used under the supervision of a qualified clinician experienced in therapy with cytotoxic agents.¹

Administration

Oral Administration

Administer orally with water twice daily within 30 minutes after the end of a meal, in the morning and evening.¹

Round recommended dose to the nearest 150-mg dose; administer whole tablets.¹

Tablets should not be chewed, cut, or crushed.¹

If a dose is missed or vomited, skip missed/vomited dose and resume with next scheduled dose.¹

Pharmacogenomic Considerations in Dosing

Patients who are intermediate or poor metabolizers of dihydropyrimidine dehydrogenase (DPYD) may be at increased risk for severe/fatal adverse effects with fluoropyrimidines (5-fluorouracil and capecitabine).⁷⁰⁰ Clinical Pharmacogenetics Implementation Consortium (CPIC) recommends capecitabine dosage reductions for intermediate and poor DPYD metabolizers.⁷⁰⁰ For DPYD intermediate metabolizers (i.e., DPYD activity score 1 or 1.5), reduce dose by 50% if activity score is 1 and reduce by 25—50% if activity score is 1.5.⁷⁰⁰ For DPYD poor metabolizers (i.e., DPYD activity score 0 or 0.5), it is strongly recommended to avoid use of capecitabine.⁷⁰⁰ If activity score is 0.5 and use cannot be avoided, administer at a markedly reduced dosage.⁷⁰⁰ Consult CPIC guideline for more details and definitions of DPYD phenotypes based on genotype.⁷⁰⁰

Dosage

Adults

Breast Cancer

Combination Therapy

Oral

1000 or 1250 mg/m² twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity occurs, in combination with docetaxel.¹ Docetaxel 75 mg/m² is administered IV on day 1 of each cycle.¹

Monotherapy

Oral

1000 or 1250 mg/m² twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity occurs.¹ Individualize the dosing schedule based on patient-specific factors (i.e., risk factors, adverse reactions).¹

Colorectal Cancer

Adjuvant Therapy for Colon Cancer

Oral

Monotherapy: 1250 mg/m² twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles.¹

Combination therapy: 1000 mg/m² twice daily for the first 14 days of each 21-day cycle for a maximum of 8 cycles in combination with oxaliplatin 130 mg/m² administered IV on day 1 of each cycle.¹

Perioperative Treatment of Rectal Cancer

Oral

In combination with radiation therapy: 825 mg/m² twice daily.¹

As part of a regimen that does not include radiation therapy: 1250 mg/m² twice daily.¹

Unresectable or Metastatic Colorectal Cancer

Oral

Monotherapy: 1250 mg/m² twice daily for the first 14 days of a 21-day cycle until disease progression or unacceptable toxicity occurs.¹

Combination therapy: 1000 mg/m² twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity occur.¹ Use in combination with oxaliplatin 130 mg/m² administered IV on day 1 of each cycle.¹

Gastric, Esophageal, or Gastroesophageal Junction Cancer

Unresectable or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Cancer

Oral

625 mg/m² twice daily on days 1—21 of each 21-day cycle for a maximum of 8 cycles.¹ Use in combination with platinum-containing chemotherapy.¹ Refer to the prescribing information for dosing recommendations for combination agents.¹

Alternately, 850 mg/m² or 1000 mg/m² twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity occurs.¹ Use in combination with oxaliplatin 130 mg/m² administered IV on day 1 of each cycle.¹

Human Epidermal Growth Factor Receptor (HER)2-Overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Oral

1000 mg/m²twice daily for the first 14 days of each 21-day cycle until disease progression or unacceptable toxicity occurs.¹ Use in combination with cisplatin and trastuzumab.¹ Refer to the prescribing information for dosing recommendations for combination agents.¹

Pancreatic Cancer

Oral

830 mg/m² twice daily for the first 21 days of each 28-day cycle until disease progression, unacceptable toxicity, or for a maximum of 6 cycles in combination with gemcitabine 1000 mg/m² administered IV on days 1, 8, and 15 of each cycle.¹

Dosage Modification for Toxicity

Monitor for adverse reactions during treatment; modify dosages as indicated (see Table 1).¹ When administered with docetaxel, withhold both drugs until requirements for resumption of both agents met.¹ Refer to prescribing information for docetaxel for additional dosing information.¹

If grade 3 or 4 hyperbilirubinemia develops, withhold treatment and resume once resolved to grade 2 or less.¹ Use the percent of current dose column of Table 1 to determine appropriate dosage for resumption.¹

Special Populations

Hepatic Impairment

No specific dosage recommendations; monitor more frequently for adverse reactions.¹

Renal Impairment

Patients with mild to moderate (Cl_cr 30—50 mL/min per Cockroft-Gault equation) renal impairment: Reduce dosage by 25%.¹

Patients with severe (Cl_cr <30 mL/min) renal impairment: Dosage not established.¹ If no alternative treatment exists for such patients, capecitabine can be administered on an individual basis using a reduced starting dose, close monitoring, and dosage modifications guided by adverse events.¹

Geriatric Patients

No specific dosage recommendations.¹

Cautions for Capecitabine

Contraindications

• History of severe hypersensitivity reactions to fluorouracil or capecitabine.¹

Warnings/Precautions

Warnings

Increased Risk of Bleeding with Concomitant Use of Vitamin K Antagonists

Altered coagulation parameters and/or bleeding, sometimes fatal, reported in patients receiving capecitabine concomitantly with vitamin K anticoagulants (e.g., warfarin) (see Boxed Warning).¹ Generally occurs within several days to months following initiation of therapy.¹

Alterations in anticoagulant effect reported in patients with or without liver metastases.¹

Monitor anticoagulant response (PT or INR) frequently, and adjust dose of the vitamin K antagonist accordingly in patients receiving concomitant therapy.¹

Other Warnings and Precautions

Cardiotoxicity

Risk of MI/ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, ECG changes, and cardiomyopathy.¹ Increased incidence in patients with a history of coronary artery disease.¹ If cardiotoxicity occurs, withhold therapy as appropriate; safety of resumption after development of cardiotoxicity not established.¹

Diarrhea

Possible diarrhea, sometimes severe or life-threatening.¹

Withhold treatment if diarrhea occurs; dosage modification or permanent discontinuation may be necessary upon resumption depending on frequency and severity of symptoms.¹

Dehydration

Dehydration can occur, especially in patients with anorexia, asthenia, nausea, vomiting, or diarrhea.¹

Optimize hydration prior to treatment; monitor hydration status and kidney function at baseline and as indicated.¹ Withhold treatment if dehydration occurs; dosage modification or permanent discontinuation may be necessary upon resumption depending on frequency and severity of symptoms.¹

Renal Toxicity

Risk of acute renal failure secondary to dehydration, which can be fatal; patients with preexisting renal impairment and those receiving concomitant therapy with nephrotoxic agents are at increased risk.¹

Optimize hydration prior to treatment; monitor hydration status and kidney function at baseline and as indicated.¹ Withhold treatment if renal toxicity occurs; dosage modification or permanent discontinuation may be necessary upon resumption depending on frequency and severity of symptoms.¹

Serious Skin Toxicities

Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes fatal, reported.¹ If such reactions occur, permanently discontinue therapy.¹

Palmar-Plantar Erythrodysesthesia Syndrome

Palmar-plantar erythrodysesthesia syndrome can occur.¹

Withhold treatment if palmar-plantar erythrodysesthesia syndrome occurs; dosage modification or permanent discontinuation may be necessary upon resumption depending on frequency and severity of symptoms.¹

Myelosuppression

Myelosuppression can occur.¹

Necrotizing enterocolitis (typhlitis) reported.¹

Monitor CBC at baseline and before each cycle.¹ Treatment not recommended if baseline neutrophil count <1500/mm³ or platelet count <100,000/mm³.¹ If grade 3 or 4 myelosuppression occurs, withhold therapy.¹ Dosage modification or permanent discontinuation may be necessary upon resumption depending on frequency of symptoms.¹

Hyperbilirubinemia

Risk of severe, possibly life-threatening hyperbilirubinemia, occurring alone or in combination with docetaxel.¹

Withhold treatment if myelosuppression occurs; dosage modification or permanent discontinuation may be necessary upon resumption depending on frequency of symptoms.¹

If grade 3 or 4 elevations in serum bilirubin concentration occur, discontinue administration of capecitabine until the hyperbilirubinemia resolves or decreases in intensity to grade 2 or less.¹

Eye Irritation, Skin Rash, and Other Adverse Reactions from Exposure to Crushed Tablets

Eye irritation and swelling, skin rash, diarrhea, paresthesia, headache, gastric irritation, nausea, and vomiting have occurred following exposure to crushed capecitabine tablets.¹ If tablets must be cut or crushed, this should be done by a trained professional and not the patient.¹ Safety and effectiveness of administering crushed tablets not established.¹

Pharmacogenomics of Capecitabine-Induced Serious Adverse Reactions Due to Dihydropyrimidine Dehydrogenase (DPD) Activity Deficiency

DPD, encoded by the DPYD gene, is responsible for catabolizing >80% of fluorouracil.¹ Acute early-onset or unusually severe capecitabine toxicity may indicate near complete or total absence of DPD activity; withhold or permanently discontinue capecitabine in such patients.¹

Certain homozygous or compound heterozygous mutations in the DPD gene result in complete or near complete absence of DPD activity.¹ Patients with such mutations (i.e., poor DPYD metabolizers) are at increased risk for acute early-onset and severe, life-threatening, or fatal capecitabine toxicity (e.g., mucositis, diarrhea, neutropenia, neurotoxicity).^{1 700} Patients with partial DPD activity (i.e., intermediate DPYD metabolizers) also may have increased risk of severe, life-threatening, or fatal toxicity.^{1 700}

No dosage of capecitabine has been proven safe for patients with complete absence of DPD activity; data insufficient to support dosage recommendations for those with partial DPD activity.¹

Consider testing for genetic variants of DPYD prior to initiating treatment; however, serious adverse reactions can still occur even if no variants identified.¹

The Clinical Pharmacogenetics Implementation Consortium (CPIC) provides recommendations for capecitabine dosing guided by DPYD phenotype.⁷⁰⁰ Dosage adjustments recommended for patients who are DPYD poor or intermediate metabolizers.⁷⁰⁰ (See Dosage and Administration.) Consult CPIC guideline for additional details.⁷⁰⁰

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm based on mechanism of action and animal findings; embryotoxicity and teratogenicity demonstrated in animals.¹

Confirm pregnancy status prior to initiating therapy.¹ Females of reproductive potential should use effective contraceptive methods while receiving capecitabine and for 6 months after the drug is discontinued.¹ Males who are partners of such females should use effective contraceptive methods while receiving the drug and for 3 months after the drug is discontinued.¹ Apprise patients of potential fetal hazard if the drug is used during pregnancy.¹

Specific Populations

Pregnancy

May cause fetal harm.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk in mice.¹ Not known whether capecitabine is distributed into milk in humans or affects milk production or nursing infants.¹

Women should not breast-feed during therapy and for 1 week following the last dose.¹

Females and Males of Reproductive Potential

Based on animal studies, may impair fertility.¹ Verify pregnancy status in females of reproductive potential prior to treatment initiation.¹ Advise females of reproductive potential to use effective contraception during treatment with capecitabine and for 6 months following discontinuation.¹ Advise male partners of such females to use effective contraception during treatment and for 3 months following discontinuation.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

No differences in efficacy between geriatric patients and younger patients in clinical trials.¹ However, geriatric patients experience increased GI toxicity from capecitabine.¹ Deaths from severe enterocolitis, diarrhea, and dehydration reported in geriatric patients treated with leucovorin and fluorouracil.¹

Hepatic Impairment

Mild or moderate hepatic impairment: systemic exposure and maximum serum concentration not affected.¹

Severe hepatic impairment: impact on pharmacokinetics not known.¹

Renal Impairment

Exposure to capecitabine and its metabolites increased in patients with renal impairment.¹

Common Adverse Effects

Adjuvant treatment of colon cancer (monotherapy; ≥30%): palmar-plantar erythrodysesthesia syndrome, diarrhea, and nausea.¹

Metastatic colorectal cancer (monotherapy; ≥30%): anemia, diarrhea, palmar-plantar erythrodysesthesia syndrome, hyperbilirubinemia, nausea, fatigue, and abdominal pain.¹

Metastatic breast cancer (monotherapy; ≥30%): lymphopenia, anemia, diarrhea, hand-and-foot syndrome, nausea, fatigue, vomiting, and dermatitis.¹

Metastatic breast cancer (combination with docetaxel; ≥30%): lymphocytopenia, leukopenia, neutropenia, anemia, diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome, nausea, alopecia, thrombocytopenia, vomiting, edema, and abdominal pain.¹

Drug Interactions

Inhibitor of CYP2C9.¹

Does not inhibit CYP isoenzymes 1A2, 2A6, 3A4, 2C9, 2C19, 2D6, or 2E1 in vitro.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Increases exposure of CYP2C9 substrates, which may increase risk of adverse events from the substrate drug.¹ When used concomitantly with CYP2C9 substrates where minimal concentration changes may lead to serious adverse reactions (e.g., anticoagulants, antidiabetic agents), closely monitor for adverse events.¹

Nephrotoxic Drugs

Possible increased risk of renal toxicity when used concomitantly due to additive pharmacologic effect.¹

Specific Drugs

Capecitabine Pharmacokinetics

Absorption

Bioavailability

Readily absorbed from the GI tract; about 70% is absorbed.^{5 14}

Peak plasma concentrations of capecitabine occur in about 1.5 hours, and peak plasma concentrations of fluorouracil occur slightly later at 2 hours.¹

Food

Food decreases the rate and extent of absorption and, to a lesser extent, decreases the peak plasma concentration and AUC of its metabolites.¹

Special Populations

Reduced peak plasma concentration and AUC of capecitabine and its catabolite, α-fluoro-β-alanine (FBAL) reported in Japanese patients compared with white patients.¹ Clinical importance of these differences is not known.¹

Among patients 27–86 years of age, a 20% increase in age is associated with a 15% increase in the AUC of FBAL.¹

Distribution

Extent

Studies have shown a higher concentration of fluorouracil, its active moiety, in tumor than in surrounding normal tissue, plasma, or muscle.¹

Not known whether capecitabine or its metabolites or are distributed into human milk; capecitabine is distributed into mouse milk.¹

Plasma Protein Binding

<60% (mainly albumin); not concentration dependent.¹

Elimination

Metabolism

Capecitabine is a prodrug of fluorouracil; metabolized to fluorouracil following oral administration.¹

Extensively metabolized in the liver and tumors to inactive, intermediate metabolites that are hydrolyzed mainly in tumor tissue to the active moiety fluorouracil.¹

Fluorouracil is anabolized to active metabolites, 5-fluoro-2′-deoxyuridine-5′-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP).¹

Fluorouracil is catabolized by dihydropyrimidine dehydrogenase to dihydrofluorouracil (FUH₂).¹

Elimination Route

Excreted principally in urine (96%) as metabolites; fecal excretion is minimal (2.6%).¹

Half-life

About 45 minutes for capecitabine and fluorouracil.¹

Special Populations

Increased systemic exposure in patients with renal impairment; systemic exposure to capecitabine was about 25% greater in patients with moderate or severe renal impairment than in those with normal renal function.¹

Dialysis may reduce circulating concentrations of 5′-DFUR, a low molecular weight metabolite of the drug.¹

Stability

Storage

Oral

Tablets

Tight containers at 20-25°C (excursions permitted to 15–30°C.)¹

Actions

• Prodrug; has little pharmacologic activity until it is converted to fluorouracil, an antimetabolite.^{1 5 6 7}

• Converted to fluorouracil by enzymes that are expressed at higher concentrations in many tumors than in adjacent normal tissues or plasma; high tumor concentrations of the active drug may be achieved with less systemic toxicity.^{1 3 5 14}

• Fluorouracil is metabolized in both normal and tumor cells to 5-fluoro-2′-deoxyuridine 5′-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP).^{1 4} The main mechanism of action may be the binding of the deoxyribonucleotide of the drug (FdUMP) and the folate cofactor (N^5–10-methylenetetrahydrofolate) to thymidylate synthase (TS) to form a covalently bound ternary complex, which inhibits the formation of thymidylate from 2′-deoxyuridylate, thereby interfering with DNA synthesis.^{1 4} In addition, FUTP can be incorporated into RNA in place of uridine triphosphate (UTP), producing a fraudulent RNA and interfering with RNA processing and protein synthesis.^{1 4}

• Active in xenograft tumors that are resistant to fluorouracil indicating incomplete cross-resistance between the drugs. ^{8 9}

Advice to Patients

• Stress importance of reading the manufacturer's patient information.¹

• Advise patients on vitamin K antagonists, such as warfarin, that they are at an increased risk of severe bleeding while taking capecitabine.¹ Advise these patients that the INR should be monitored more frequently, and dosage modifications of the vitamin K antagonist may be required, while taking and after discontinuation of capecitabine.¹ Advise these patients to immediately contact their healthcare provider if signs or symptoms of bleeding occur.¹

• Inform patients of the potential for serious and life-threatening adverse reactions due to dihydropyrimidine dehydrogenase (DPD) deficiency and discuss whether they should be tested for genetic variants that are associated with an increased risk of serious adverse reactions from the use of capecitabine.¹ Advise patients to immediately contact their healthcare provider if symptoms of severe mucositis, diarrhea, neutropenia, and neurotoxicity occur.¹

• Advise patients of the risk of cardiotoxicity and to immediately contact their healthcare provider for new onset of chest pain, shortness of breath, dizziness, or lightheadedness.¹

• Inform patients experiencing grade 2 diarrhea (an increase of 4 to 6 stools/day or nocturnal stools) or greater or experiencing severe bloody diarrhea with severe abdominal pain and fever to stop taking capecitabine.¹ Advise patients on the use of antidiarrheal treatments (e.g., loperamide) to manage diarrhea.¹

• Instruct patients experiencing grade 2 or greater dehydration to stop taking capecitabine immediately and to contact their healthcare provider.¹ Advise patients to not restart capecitabine until rehydrated and any precipitating causes have been corrected or controlled.¹

• Instruct patients experiencing decreased urinary output or other signs and symptoms of renal toxicity to immediately contact their healthcare provider.¹

• Instruct patients with skin rash, blistering, or peeling to immediately contact their healthcare provider.¹

• Instruct patients experiencing grade 2 or greater palmar-plantar erythrodysesthesia syndrome to stop taking capecitabine immediately and to contact their healthcare provider.¹ Inform patients that initiation of symptomatic treatment is recommended and hand-and-foot syndrome can lead to loss of fingerprints, which could impact personal identification.¹

• Inform patients who develop a fever of 100.5°F or greater or other evidence of potential infection to immediately contact their healthcare provider.¹

• Inform patients who develop jaundice or icterus to immediately contact their healthcare provider.¹

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.¹ Advise pregnant women and females of reproductive potential of the potential risk to a fetus.¹ Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy.¹ Advise females not to breast-feed during treatment with capecitabine and for 1 week after the last dose.¹

• Advise males and females of reproductive potential that capecitabine may impair fertility.¹ Advise females of reproductive potential to use effective contraception during treatment with capecitabine and for 6 months after the last dose.¹ Advise males with female partners of reproductive potential to use effective contraception during treatment with capecitabine and for 3 months after the last dose.¹

• Advise patients that capecitabine may cause severe hypersensitivity reactions and angioedema.¹ Advise patients who have known hypersensitivity to capecitabine or 5-fluorouracil to inform their healthcare provider.¹ Instruct patients who develop hypersensitivity reactions or mucocutaneous symptoms (e.g., urticaria, rash, erythema, pruritus, or swelling of the face, lips, tongue, or throat which make it difficult to swallow or breathe) to stop taking capecitabine and immediately contact their healthcare provider or go to an emergency room.¹

• Instruct patients experiencing grade 2 nausea (food intake significantly decreased but able to eat intermittently) or greater to stop taking capecitabine and to immediately contact their healthcare provider for management of nausea.¹ Instruct patients experiencing grade 2 vomiting (2 to 5 episodes in a 24-hour period) or greater to stop taking capecitabine immediately and to contact their healthcare provider for management of vomiting.¹

• Inform patients experiencing grade 2 stomatitis (painful erythema, edema, or ulcers of the mouth or tongue, but able to eat) or greater to stop taking capecitabine immediately and to contact their healthcare provider.¹

• Advise patients to swallow capecitabine tablets whole with water within 30 minutes after a meal.¹ Advise patients and caregivers not to chew, crush, or cut capecitabine tablets.¹ Advise patients if they cannot swallow capecitabine tablets whole to inform their healthcare provider.¹

• Instruct patients not to take products containing folic acid or folate analog products (e.g., leucovorin, levoleucovorin) unless directed to do so by their healthcare provider.¹ Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.¹

• Inform patients of other important precautionary information.¹

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care. For further information on the handling of antineoplastic agents, see the ASHP Guidelines on Handling Hazardous Drugs at [Web].

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Frequently asked questions

• Why do you need to take Xeloda with food?

Medical Disclaimer