Capecitabine medac
Oral fluoropyrimidine chemotherapy for colorectal, breast, and gastric cancer
Quick Facts About Capecitabine medac
Key Takeaways About Capecitabine medac
- Oral alternative to IV chemotherapy: Capecitabine is taken as tablets at home, replacing the need for hospital-based intravenous 5-fluorouracil infusions in many treatment regimens
- DPD testing is mandatory: Before starting treatment, patients must be tested for dihydropyrimidine dehydrogenase (DPD) deficiency, as this enzyme deficiency can lead to fatal toxicity
- Watch for hand-foot syndrome: The most characteristic side effect causes redness, swelling, and peeling on palms and soles — report symptoms early for dose adjustment
- Dangerous warfarin interaction: Capecitabine dramatically increases the effect of blood thinners like warfarin, requiring very close INR monitoring
- Cycle-based dosing: Typically taken twice daily for 14 days followed by a 7-day rest period, with the dose calculated based on body surface area
What Is Capecitabine medac and What Is It Used For?
Capecitabine medac is an oral chemotherapy drug used to treat colorectal cancer (both after surgery and in advanced disease), metastatic breast cancer, and gastric cancer. It is a prodrug that is preferentially converted to the active anticancer agent 5-fluorouracil (5-FU) within tumor cells, providing targeted antitumor activity with the convenience of oral administration.
Capecitabine medac contains the active substance capecitabine, which belongs to a class of anticancer medications known as fluoropyrimidine antimetabolites. Unlike traditional intravenous 5-fluorouracil (5-FU), which has been a cornerstone of cancer treatment since the 1950s, capecitabine is designed to be taken orally as a tablet. This represents a significant advancement in patient convenience, as it allows much of the treatment to be administered at home rather than requiring regular hospital visits for infusions.
The drug works through an elegant three-step enzymatic activation cascade. After being absorbed from the gastrointestinal tract, capecitabine is first converted to 5'-deoxy-5-fluorocytidine (5'-DFCR) in the liver by the enzyme carboxylesterase. It is then converted to 5'-deoxy-5-fluorouridine (5'-DFUR) by cytidine deaminase, which is found in the liver and in tumor tissue. The final and crucial step is the conversion of 5'-DFUR to the active drug 5-fluorouracil by the enzyme thymidine phosphorylase (TP), which is present at significantly higher concentrations in many types of tumor tissue compared to healthy tissue. This preferential activation in tumors provides a degree of selectivity, resulting in higher concentrations of 5-FU at the tumor site while reducing systemic toxicity.
Once activated, 5-fluorouracil exerts its anticancer effects primarily by inhibiting the enzyme thymidylate synthase, which is essential for DNA synthesis and cell division. By blocking this enzyme, 5-FU disrupts the production of thymidine, one of the building blocks of DNA, ultimately preventing cancer cells from replicating and leading to cell death. Additionally, 5-FU metabolites are incorporated into RNA and DNA, further disrupting cellular function.
Approved Indications
Capecitabine medac is approved for use in the following clinical settings, based on extensive clinical trial evidence:
- Adjuvant treatment of colon cancer (Stage III, Dukes' C): After surgical removal of the primary tumor, capecitabine is used to reduce the risk of cancer recurrence. The landmark X-ACT trial demonstrated that capecitabine was at least as effective as intravenous 5-FU/leucovorin in this setting, with superior disease-free survival
- Metastatic colorectal cancer: For patients with advanced colorectal cancer that has spread to other parts of the body, capecitabine can be used as a single agent or in combination with other drugs such as oxaliplatin (XELOX/CAPOX regimen) or bevacizumab
- Advanced or metastatic breast cancer: Capecitabine is used in combination with docetaxel after failure of an anthracycline-containing regimen, or as monotherapy after failure of both anthracycline and taxane-based chemotherapy, or when further anthracycline therapy is not appropriate
- Locally advanced or metastatic gastric cancer: As a first-line treatment in combination with a platinum-based chemotherapy regimen such as oxaliplatin or cisplatin
Capecitabine medac is a generic formulation manufactured by medac GmbH. The original branded product, Xeloda, was developed by Hoffmann-La Roche. Generic capecitabine products contain the same active ingredient and have been approved based on demonstrated bioequivalence, meaning they deliver the same amount of active drug to the bloodstream as the original product.
What Should You Know Before Taking Capecitabine medac?
Before starting capecitabine medac, you must be tested for DPD (dihydropyrimidine dehydrogenase) deficiency, as patients with this enzyme deficiency can experience severe, life-threatening toxicity. You should also inform your doctor about all medications you take, especially blood thinners, and disclose any history of heart disease, liver or kidney problems.
Capecitabine is a powerful chemotherapy agent that requires careful assessment before treatment can begin. Your oncologist will evaluate your overall health status, organ function, and genetic factors to determine whether capecitabine is safe and appropriate for you. Understanding the contraindications, warnings, and precautions is essential for minimizing the risk of serious adverse events during treatment.
Contraindications
You must not take capecitabine medac if any of the following apply:
- Known complete DPD deficiency: Patients with complete absence of dihydropyrimidine dehydrogenase (DPD) activity must not receive capecitabine under any circumstances, as fatal toxicity will occur
- Hypersensitivity: Known allergy to capecitabine, 5-fluorouracil, or any of the excipients in the tablet formulation
- Severe leukopenia, neutropenia, or thrombocytopenia: Dangerously low white blood cell or platelet counts at baseline
- Severe hepatic impairment: Significant liver dysfunction that would impair drug metabolism
- Severe renal impairment: Creatinine clearance below 30 mL/min at baseline
- Treatment with sorivudine or brivudine: These antiviral drugs inhibit DPD and must not be co-administered. A minimum 4-week washout period is required after stopping sorivudine or brivudine before capecitabine can be started
- Pregnancy and breastfeeding: Capecitabine is teratogenic and must not be used during pregnancy. Effective contraception is required during treatment and for at least 6 months after the last dose
Warnings and Precautions
Talk to your doctor or pharmacist before taking capecitabine medac if any of the following situations apply to you:
- Partial DPD deficiency: Patients with partial DPD deficiency (determined by genotyping for DPYD gene variants) may require a reduced starting dose, as they are at increased risk of severe toxicity. The EMA recommends testing for the four most clinically relevant DPYD variants (DPYD*2A, DPYD*13, c.2846A>T, and c.1236G>A/HapB3) before treatment initiation
- Kidney problems: If you have moderate renal impairment (creatinine clearance 30–50 mL/min), a reduced starting dose is recommended. Your kidney function will be monitored during treatment
- Liver problems or liver metastases: If you have liver disease or cancer that has spread to the liver, you will be monitored more closely for liver function deterioration
- Heart disease: Capecitabine can cause cardiotoxicity, including angina, myocardial infarction, arrhythmias, cardiogenic shock, and sudden death. Patients with a history of coronary artery disease, heart failure, or cardiac arrhythmias should be monitored carefully
- Electrolyte imbalances: Low blood calcium (hypocalcemia) or potassium (hypokalemia) should be corrected before starting treatment
- Diabetes: Blood glucose levels may become harder to control during capecitabine treatment
- Central nervous system disease: Patients with CNS metastases or pre-existing neuropathy may experience worsening symptoms
Dihydropyrimidine dehydrogenase (DPD) is the rate-limiting enzyme responsible for breaking down fluoropyrimidines like capecitabine. Approximately 3–8% of the population carries genetic variants that result in partial or complete DPD deficiency. In patients with unrecognized DPD deficiency, standard doses of capecitabine can lead to rapidly developing, severe, life-threatening, or fatal toxicity including severe neutropenia, sepsis, mucositis, diarrhea, and gastrointestinal hemorrhage. Testing for DPD deficiency by genotyping and/or phenotyping is now mandatory across the European Union before initiating any fluoropyrimidine-based treatment.
Pregnancy and Breastfeeding
Capecitabine must not be used during pregnancy. Animal studies have shown that capecitabine causes embryo lethality and teratogenicity (birth defects). Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. Male patients with female partners of childbearing potential should also use effective contraception during treatment and for 3 months after the last dose.
It is not known whether capecitabine or its metabolites are excreted in human breast milk. However, given the mechanism of action and the potential for serious harm to a nursing infant, breastfeeding must be stopped during treatment with capecitabine and should not be resumed during the treatment period.
If you become pregnant during treatment, inform your doctor immediately. Your medical team will discuss the risks and options with you. If you are planning a pregnancy, treatment with capecitabine should be completed and an adequate washout period observed before conceiving.
How Does Capecitabine medac Interact with Other Drugs?
Capecitabine has several clinically significant drug interactions. The most dangerous is with coumarin anticoagulants (warfarin), where capecitabine markedly increases bleeding risk. It also interacts fatally with sorivudine/brivudine and has important interactions with phenytoin, leucovorin, and CYP2C9 substrates.
Drug interactions are a critical concern with capecitabine treatment. Because capecitabine is metabolized through a complex enzymatic pathway and its active metabolite 5-FU affects multiple biochemical processes, it can interact with a wide range of medications. Your oncologist and pharmacist will carefully review all your current medications, including over-the-counter drugs and herbal supplements, before starting capecitabine therapy. Always inform your healthcare team before starting or stopping any medication during your treatment.
Major Interactions
| Interacting Drug | Effect | Clinical Significance | Action Required |
|---|---|---|---|
| Sorivudine / Brivudine | Irreversible DPD inhibition leading to massive 5-FU accumulation | Fatal interaction — deaths reported | Absolutely contraindicated. Minimum 4-week washout required |
| Warfarin / Coumarin anticoagulants | Markedly increased anticoagulant effect with elevated INR | Severe or fatal bleeding events reported | Very frequent INR monitoring; dose adjustment; consider LMWH alternative |
| Phenytoin | Increased phenytoin plasma levels due to CYP2C9 inhibition | Risk of phenytoin toxicity (ataxia, nystagmus, seizures) | Monitor phenytoin levels regularly; adjust dose as needed |
| Leucovorin (folinic acid) | Enhances 5-FU cytotoxicity by stabilizing 5-FU–thymidylate synthase complex | Increased efficacy but also increased toxicity | Maximum tolerated dose of capecitabine is reduced when combined |
| Allopurinol | May reduce efficacy of capecitabine | Potential treatment failure | Avoid concurrent use if possible |
Minor Interactions
In addition to the major interactions listed above, capecitabine may interact with the following categories of medications, requiring monitoring or dose adjustment:
- CYP2C9 substrates: Capecitabine inhibits CYP2C9, which may increase plasma levels of other drugs metabolized by this enzyme, including certain nonsteroidal anti-inflammatory drugs (NSAIDs) and oral hypoglycemic agents
- Antacids containing aluminum and magnesium hydroxide: May cause a small increase in capecitabine plasma levels, though this is generally not clinically significant
- Live vaccines: Immunosuppression caused by capecitabine may lead to severe or fatal infections from live vaccines. Live vaccination should be avoided during treatment
- Interferon alfa: When combined with capecitabine, the maximum tolerated dose of capecitabine is reduced, and toxicity may be increased
- Radiation therapy: Capecitabine has radiosensitizing properties and may increase both the efficacy and toxicity of concurrent radiotherapy. This combination is used deliberately in some treatment protocols (e.g., neoadjuvant chemoradiation for rectal cancer)
Always carry a current medication list and show it to every healthcare professional you see. If you take warfarin or another blood thinner, expect to have your INR checked more frequently — sometimes weekly or even more often during capecitabine treatment. If you are prescribed any new medication by another doctor while on capecitabine, always inform your oncologist first.
What Is the Correct Dosage of Capecitabine medac?
The standard dose of capecitabine is 1250 mg/m² taken orally twice daily (morning and evening) for 14 days, followed by a 7-day rest period (21-day cycle). The dose is calculated based on your body surface area (BSA). Tablets should be swallowed whole with water within 30 minutes after a meal.
Capecitabine dosing is individualized based on each patient's body surface area (BSA), which is calculated from their height and weight. The treating oncologist will determine the exact number of tablets to take at each dose. It is crucial to follow the prescribed dosing schedule precisely, as both underdosing and overdosing can have significant consequences for treatment outcomes and safety.
Adults
Standard Monotherapy Dosage
The recommended starting dose when capecitabine is used as a single agent is 1250 mg/m² administered orally twice daily (equivalent to a total daily dose of 2500 mg/m²). Treatment is given in 3-week cycles: 14 consecutive days of treatment followed by a 7-day rest period.
Combination Therapy Dosage
When capecitabine is used in combination with other chemotherapy agents, the starting dose is often reduced. Common combination regimens include:
- CAPOX/XELOX (with oxaliplatin): Capecitabine 1000 mg/m² twice daily for 14 days, plus oxaliplatin on day 1, in 21-day cycles
- With docetaxel (breast cancer): Capecitabine 1250 mg/m² twice daily for 14 days, plus docetaxel on day 1, in 21-day cycles
- With cisplatin (gastric cancer): Capecitabine 1000 mg/m² twice daily for 14 days, plus cisplatin on day 1, in 21-day cycles
| Body Surface Area (m²) | Dose Per Administration (mg) | Number of 150 mg Tablets |
|---|---|---|
| ≤ 1.26 | 1500 mg | 10 |
| 1.27 – 1.38 | 1650 mg | 11 |
| 1.39 – 1.52 | 1800 mg | 12 |
| 1.53 – 1.66 | 2000 mg | Combination of 150 mg & 500 mg tablets |
| 1.67 – 1.78 | 2150 mg | Combination of 150 mg & 500 mg tablets |
| ≥ 1.79 | 2500 mg | Combination of 150 mg & 500 mg tablets |
Children
Capecitabine is not recommended for use in children and adolescents under 18 years of age. There are insufficient data on its safety and efficacy in the pediatric population. Pediatric cancers typically require different treatment approaches, and the use of capecitabine in this age group has not been adequately studied in clinical trials.
Elderly
No general dose adjustment is necessary solely based on age. However, elderly patients are more likely to have reduced kidney function, and dose adjustments based on creatinine clearance should be considered. Elderly patients may also be more susceptible to certain side effects, particularly hand-foot syndrome, diarrhea, and dehydration. Close monitoring is recommended, and your doctor may consider starting at a slightly lower dose in patients over 65 years of age, particularly those with comorbidities.
Patients with Renal Impairment
Dose Adjustments for Kidney Function
- Mild impairment (CrCl 51–80 mL/min): No dose adjustment required at the start of treatment
- Moderate impairment (CrCl 30–50 mL/min): Reduce starting dose to 75% of the standard dose (approximately 950 mg/m² twice daily)
- Severe impairment (CrCl <30 mL/min): Capecitabine is contraindicated
Missed Dose
If you miss a dose of capecitabine, do not take a double dose to make up for it. Simply skip the missed dose and take your next scheduled dose at the usual time. Taking extra tablets to compensate for a missed dose increases the risk of serious side effects. If you miss multiple doses, contact your oncologist or cancer care team for advice on how to proceed with your treatment schedule.
Overdose
Symptoms of capecitabine overdose include nausea, vomiting, diarrhea, mucosal inflammation (stomatitis), gastrointestinal irritation and bleeding, and bone marrow suppression. If you suspect an overdose, seek emergency medical attention immediately. Treatment is supportive and may include granulocyte colony-stimulating factor (G-CSF) for neutropenia, fluid replacement for dehydration, and hospitalization for monitoring. There is no specific antidote for capecitabine overdose.
What Are the Side Effects of Capecitabine medac?
The most common side effects of capecitabine include diarrhea, nausea, vomiting, hand-foot syndrome (palmar-plantar erythrodysesthesia), stomatitis (mouth sores), fatigue, and decreased appetite. Some side effects can be serious and may require dose reduction or treatment interruption. Report any new or worsening symptoms to your healthcare team promptly.
Like all chemotherapy medications, capecitabine can cause side effects. Not everyone will experience all of these effects, and their severity can vary significantly between patients. Many side effects are dose-dependent and can be managed by temporary treatment interruption or dose reduction. Your oncologist will adjust your treatment based on the type and severity of side effects you experience. It is essential to report any new symptoms to your healthcare team promptly, as early intervention can prevent serious complications.
The side effects listed below are categorized by their frequency of occurrence based on clinical trial data and post-marketing surveillance. Understanding these frequency categories helps you put the risks in perspective, although individual experiences may vary.
Very Common (affects more than 1 in 10 patients)
- Diarrhea (sometimes severe, requiring IV fluids)
- Nausea
- Vomiting
- Stomatitis and mouth ulcers
- Hand-foot syndrome (palmar-plantar erythrodysesthesia)
- Fatigue and weakness
- Decreased appetite and anorexia
- Abdominal pain
- Dermatitis and skin rash
Common (affects 1 to 10 in 100 patients)
- Neutropenia (low white blood cell count)
- Anemia (low red blood cell count)
- Thrombocytopenia (low platelet count)
- Dehydration (often secondary to diarrhea/vomiting)
- Peripheral neuropathy (tingling, numbness in hands/feet)
- Dizziness and headache
- Taste changes (dysgeusia)
- Eye irritation and increased tearing
- Chest pain and cardiotoxicity
- Deep vein thrombosis and pulmonary embolism
- Constipation
- Upper abdominal pain and dyspepsia
- Nail changes (discoloration, ridging, loosening)
- Hyperbilirubinemia (elevated bilirubin)
- Joint and muscle pain
- Fever
- Weight loss
Uncommon (affects 1 to 10 in 1,000 patients)
- Febrile neutropenia (neutropenia with fever — medical emergency)
- Pancytopenia (low levels of all blood cells)
- Myocardial infarction (heart attack)
- Heart failure
- Cardiac arrhythmias
- Hepatic failure
- Cerebellar toxicity (ataxia, dysarthria)
- Encephalopathy
- Severe skin reactions
- Gastrointestinal hemorrhage
Rare (affects fewer than 1 in 1,000 patients)
- Stevens-Johnson syndrome (severe skin reaction)
- Toxic epidermal necrolysis
- Lacrimal duct stenosis (blocked tear duct)
- Cutaneous lupus erythematosus
- Anaphylaxis
- Severe hepatotoxicity
- Leukoencephalopathy
Hand-Foot Syndrome: A Closer Look
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia (PPE), is the most characteristic side effect of capecitabine and deserves special attention. It occurs because capecitabine and its metabolites accumulate in the sweat glands of the palms and soles, causing direct damage to the skin.
HFS develops gradually and is graded according to severity:
- Grade 1: Numbness, tingling, painless swelling, or redness of hands and/or feet. Daily activities are not affected. Treatment continues at the same dose
- Grade 2: Painful redness, swelling, or peeling that affects daily activities but not the ability to work. Treatment is typically interrupted until symptoms improve to grade 0–1, then resumed at a reduced dose
- Grade 3: Severe blistering, ulceration, or pain that prevents walking, grasping objects, or performing daily self-care. Treatment is interrupted and may be permanently discontinued if symptoms recur at grade 3 after two dose reductions
Management strategies for hand-foot syndrome include applying fragrance-free moisturizing creams regularly (especially urea-based creams), avoiding excessive heat exposure (hot water, direct sunlight), wearing loose-fitting cotton socks and gloves, avoiding repetitive friction on hands and feet, and staying well hydrated. Some evidence suggests that oral vitamin B6 (pyridoxine) at doses of 150–200 mg daily may help prevent or reduce the severity of HFS, although clinical trial results have been mixed.
Contact your healthcare team or seek emergency medical care immediately if you experience: severe diarrhea (more than 4 stools per day above your normal), vomiting more than once in 24 hours, signs of dehydration (dizziness, dark urine, very dry mouth), fever above 38°C (100.4°F), chest pain or shortness of breath, severe mouth sores preventing eating or drinking, or signs of bleeding (blood in stool, black tarry stools, unusual bruising).
How Should You Store Capecitabine medac?
Store capecitabine medac tablets below 30°C (86°F) in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of capecitabine medac tablets is important to maintain their effectiveness and safety throughout the treatment course. Like all medications, capecitabine should be stored under appropriate conditions to prevent degradation of the active ingredient.
Store the tablets at room temperature, below 30°C (86°F). Do not refrigerate or freeze the tablets. Keep them in the original blister packaging until use to protect them from moisture and light. Do not transfer the tablets to a pill box or other container for extended periods, as exposure to moisture may affect the tablet coating.
Do not use capecitabine medac after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month. If any tablets appear discolored, cracked, or otherwise damaged, do not take them and consult your pharmacist.
As a cytotoxic chemotherapy agent, unused or expired capecitabine tablets should not be disposed of through household waste or wastewater. Return any unused medication to your pharmacy for safe disposal in accordance with local regulations. This helps protect the environment and prevents accidental exposure to others.
What Does Capecitabine medac Contain?
Each Capecitabine medac 150 mg film-coated tablet contains 150 mg of capecitabine as the active substance, along with inactive ingredients (excipients) that form the tablet core and film coating.
Understanding the composition of your medication can be helpful, particularly if you have known allergies to specific pharmaceutical ingredients.
Active Substance
Each film-coated tablet contains 150 mg of capecitabine. Capecitabine is a white to off-white crystalline powder with the chemical name 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]-cytidine and a molecular formula of C15H22FN3O6. It has a molecular weight of 359.35 g/mol.
Excipients (Inactive Ingredients)
The inactive ingredients that make up the tablet core and film coating typically include:
- Tablet core: Lactose monohydrate (or anhydrous), croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate
- Film coating: Hypromellose, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide red (E172)
The 150 mg tablets are typically light peach-colored, biconvex, oblong film-coated tablets. The film coating serves to protect the tablet contents, make swallowing easier, and help identify the tablet strength. Patients with known lactose intolerance should discuss this with their doctor, as the tablets contain lactose monohydrate.
The tablets should be swallowed whole and must not be crushed, chewed, or broken before swallowing. The film coating is an important part of the formulation that ensures proper absorption of the active ingredient in the gastrointestinal tract. Crushing or breaking the tablets may alter the rate of drug release and could potentially expose the handler to the cytotoxic active substance.
Frequently Asked Questions About Capecitabine medac
Capecitabine medac is an oral chemotherapy medication used to treat several types of cancer. Its primary uses include colorectal cancer (both as adjuvant treatment after surgery for Stage III colon cancer and as treatment for metastatic colorectal cancer), metastatic breast cancer (after failure of prior chemotherapy regimens), and locally advanced or metastatic gastric (stomach) cancer. It may be used alone (monotherapy) or in combination with other chemotherapy drugs such as oxaliplatin, docetaxel, or cisplatin, depending on the specific cancer type and treatment goals.
Hand-foot syndrome (palmar-plantar erythrodysesthesia or PPE) is the most characteristic side effect of capecitabine. It causes redness, swelling, numbness, tingling, and peeling of the skin on the palms and soles. In severe cases, painful blistering and cracking can develop. To manage it: apply fragrance-free moisturizing cream (especially urea-based) several times daily, avoid hot water, wear loose-fitting shoes and cotton socks, minimize friction and pressure on hands and feet, and report any symptoms to your doctor promptly. Early reporting allows your doctor to adjust your dose before symptoms become severe.
DPD (dihydropyrimidine dehydrogenase) is the enzyme your body uses to break down fluoropyrimidine drugs like capecitabine. About 3–8% of people carry genetic variants that reduce or eliminate DPD activity. In these individuals, capecitabine cannot be properly metabolized, leading to dangerous accumulation of the active metabolite 5-FU. This can cause severe, life-threatening, or fatal toxicity including overwhelming infection (sepsis), severe diarrhea, and gastrointestinal bleeding. Testing allows your doctor to either avoid capecitabine entirely (if you have complete DPD deficiency) or reduce the starting dose (if you have partial deficiency), making treatment much safer.
Capecitabine has a very significant interaction with warfarin and other coumarin-based blood thinners. It markedly increases the anticoagulant effect, which can lead to severe or even fatal bleeding. If you need to take both medications, your doctor will monitor your INR (blood clotting test) very frequently — often weekly or even more often — and will adjust your warfarin dose accordingly. In some cases, your doctor may recommend switching to a different type of blood thinner, such as low-molecular-weight heparin (LMWH), during your capecitabine treatment. Never start or stop any blood thinner without consulting your oncologist.
Take your capecitabine tablets within 30 minutes after finishing a meal (usually breakfast and dinner). Swallow the tablets whole with a glass of water — do not crush, chew, or cut them. The standard schedule is 14 days of treatment followed by 7 days off (a 21-day cycle). Take your morning dose after breakfast and your evening dose after dinner, at approximately the same times each day. If you miss a dose, do not double the next dose — simply skip the missed dose and continue with your regular schedule. If you vomit shortly after taking a dose, do not retake it; continue with your next scheduled dose and inform your doctor.
The most serious side effects requiring immediate medical attention include: severe diarrhea (more than 4 extra stools per day), as this can lead to dangerous dehydration; fever above 38°C (100.4°F), which may indicate infection due to low white blood cell counts (neutropenia); chest pain or shortness of breath, which could indicate cardiotoxicity; severe mouth sores preventing eating or drinking; signs of bleeding such as blood in your stool, black tarry stools, or unusual bruising; and severe hand-foot syndrome with blistering. Contact your cancer care team immediately if you experience any of these symptoms.
References and Sources
This article is based on the following peer-reviewed sources and official prescribing guidelines:
- European Medicines Agency (EMA). Capecitabine – Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu. Accessed February 2026.
- U.S. Food and Drug Administration (FDA). Xeloda (capecitabine) Prescribing Information. Available at: www.fda.gov. Accessed February 2026.
- Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. New England Journal of Medicine. 2005;352(26):2696-2704. doi:10.1056/NEJMoa043116
- ESMO Clinical Practice Guidelines: Metastatic colorectal cancer. Annals of Oncology. 2023. Available at: www.esmo.org.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Colon Cancer, Version 1.2026. Available at: www.nccn.org.
- EMA Recommendations on DPD testing prior to treatment with fluoropyrimidines. EMA/229267/2020. Available at: www.ema.europa.eu.
- Henricks LM, Lunenburg CATC, de Man FM, et al. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis. Lancet Oncology. 2018;19(11):1459-1467. doi:10.1016/S1470-2045(18)30686-7
- Hoff PM, Ansari R, Batist G, et al. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer. Journal of Clinical Oncology. 2001;19(8):2282-2292.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd edition, 2023. Capecitabine is listed as an essential antineoplastic agent.
- British National Formulary (BNF). Capecitabine. Available at: bnf.nice.org.uk. Accessed February 2026.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, which includes board-certified physicians with expertise in oncology, clinical pharmacology, and evidence-based medicine. Our editorial process follows the GRADE framework for evaluating evidence quality, and all content adheres to international clinical guidelines from the EMA, FDA, ESMO, and NCCN.
iMedic Medical Editorial Team — specialists in oncology and clinical pharmacology with documented experience in chemotherapy drug information.
iMedic Medical Review Board — independent panel of medical experts who verify accuracy against current guidelines and published evidence.
Declaration of Interest: iMedic receives no commercial funding. All content is produced independently with no pharmaceutical company involvement. Our editorial team has no financial relationships with manufacturers of capecitabine or competing products.