Capecitabine Accord

Oral chemotherapy for colon, rectal, gastric, and breast cancer

Rx – Prescription Only ATC: L01BC06 Antimetabolite – Fluoropyrimidine
Active Ingredient
Capecitabine
Dosage Forms
Film-coated tablets
Available Strengths
150 mg, 300 mg, 500 mg
Administration
Oral (by mouth)
Manufacturer
Accord Healthcare S.L.U.
Known Brands
Capecitabine Accord
Medically reviewed | Last reviewed: | Evidence level: 1A
Capecitabine Accord is a prescription chemotherapy medicine containing capecitabine, a prodrug that is converted to the active anticancer agent 5-fluorouracil (5-FU) preferentially within tumor tissue. It is used to treat colon cancer, rectal cancer, gastric (stomach) cancer, and breast cancer, and can also prevent colon cancer recurrence after surgery. This page covers uses, dosage, side effects, drug interactions, storage, and ingredients.
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Quick Facts About Capecitabine Accord

Active Ingredient
Capecitabine
Fluoropyrimidine prodrug
Drug Class
Antimetabolite
Pyrimidine analogue
ATC Code
L01BC06
Antineoplastic agent
Common Uses
4 Cancer Types
Colon, rectal, gastric, breast
Available Forms
Tablets
150 mg, 300 mg, 500 mg
Prescription Status
Rx Only
Prescription required

Key Takeaways About Capecitabine Accord

  • Prodrug that targets tumors: Capecitabine is inactive until converted to 5-FU preferentially in tumor tissue, which may reduce systemic toxicity compared to intravenous 5-FU
  • DPD testing is essential: Patients must be tested for DPD (dihydropyrimidine dehydrogenase) deficiency before starting treatment, as deficiency can cause life-threatening toxicity
  • Standard 21-day cycle: Typically taken for 14 days followed by a 7-day rest period, with dosing based on body surface area
  • Stop immediately if severe side effects occur: Diarrhea, vomiting, mouth sores, hand-foot syndrome, or fever require immediate medical attention and treatment interruption
  • Dangerous interaction with brivudine: Must never be taken with brivudine (antiviral for shingles) – wait at least 4 weeks after stopping brivudine before starting capecitabine

What Is Capecitabine Accord and What Is It Used For?

Capecitabine Accord is an oral chemotherapy medicine belonging to a group called cytostatics (antineoplastic agents). It contains the active ingredient capecitabine, which is a prodrug – meaning it is not directly cytotoxic but is converted into the active anticancer agent 5-fluorouracil (5-FU) after being absorbed by the body, preferentially within tumor tissue.

Capecitabine belongs to the class of medicines known as antimetabolites, specifically the fluoropyrimidine family. Unlike intravenous 5-fluorouracil, which has been a cornerstone of cancer chemotherapy for decades, capecitabine offers the convenience of oral administration. After ingestion, capecitabine undergoes a three-step enzymatic conversion process. The final step is catalyzed by the enzyme thymidine phosphorylase, which is found in higher concentrations in many tumor types compared to healthy tissue. This preferential activation in tumors is a key pharmacological advantage of capecitabine, as it helps to maximize anticancer efficacy while potentially reducing exposure to normal tissues.

Once converted to 5-FU, the drug 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 prevents cancer cells from replicating their DNA, ultimately leading to cell death. Additionally, 5-FU metabolites are incorporated directly into RNA and DNA, further disrupting cellular function and contributing to cancer cell death.

Approved indications

Capecitabine Accord is approved for the treatment of several types of cancer:

  • Colon cancer: Used as adjuvant treatment after surgery (to reduce the risk of cancer returning) in patients with stage III (Dukes' C) colon cancer
  • Colorectal cancer: Used for the treatment of metastatic colorectal cancer (cancer that has spread to other parts of the body)
  • Gastric cancer: Used in combination with a platinum-based chemotherapy regimen as first-line treatment for advanced gastric (stomach) cancer
  • Breast cancer: Used in combination with docetaxel for locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, or as monotherapy after failure of taxanes and an anthracycline-containing regimen

Your oncologist will determine which treatment approach is most appropriate for your specific type and stage of cancer. Capecitabine can be used either alone (monotherapy) or in combination with other anticancer medicines, depending on the clinical situation.

How capecitabine works in your body

After you swallow a capecitabine tablet, it is rapidly absorbed from the gastrointestinal tract and then undergoes a three-step enzymatic conversion. The first two steps occur in the liver and other tissues. The critical third step – conversion to the active drug 5-fluorouracil – happens preferentially inside tumor cells, where the enzyme thymidine phosphorylase is present at higher levels. This targeted activation is what makes capecitabine effective against cancer while helping to limit damage to healthy tissues.

What Should You Know Before Taking Capecitabine Accord?

Before starting Capecitabine Accord, your doctor must verify that you do not have a complete DPD enzyme deficiency, as this can cause life-threatening toxicity. You must also not take this medicine if you are allergic to capecitabine, if you have previously had severe reactions to fluoropyrimidine therapy, or if you are pregnant or breastfeeding.

Capecitabine Accord is a potent chemotherapy medicine that requires careful medical supervision. Before starting treatment, your healthcare provider will conduct several assessments to ensure this medicine is appropriate and safe for you. It is crucial that you share your complete medical history, current medications, and any known allergies with your doctor.

Contraindications – Do not take Capecitabine Accord if:

  • You are allergic to capecitabine or any of the other ingredients in this medicine
  • You have previously had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines such as fluorouracil)
  • You are pregnant or breastfeeding
  • You have severely low levels of white blood cells or platelets in your blood (leukopenia, neutropenia, or thrombocytopenia)
  • You have severe liver or kidney problems
  • You are known to have complete absence of DPD enzyme activity (dihydropyrimidine dehydrogenase deficiency)
  • You are being treated with, or have been treated within the last 4 weeks with, brivudine (an antiviral medicine for shingles or chickenpox)
Critical Warning: DPD Deficiency

DPD (dihydropyrimidine dehydrogenase) deficiency is an inherited condition that prevents the body from properly breaking down fluoropyrimidine medicines. If you have complete DPD deficiency, you must never take Capecitabine Accord – the consequences can be fatal. Even partial DPD deficiency significantly increases the risk of severe, life-threatening side effects. Your doctor should test you for DPD deficiency before starting treatment. If you have partial deficiency, your doctor may prescribe a reduced dose. Be aware that serious toxicity can still occur even with a negative DPD test result.

Warnings and precautions

Talk to your doctor or pharmacist before taking Capecitabine Accord if any of the following apply to you:

  • You have liver or kidney disease – your dose may need to be adjusted and kidney function should be monitored regularly
  • You have or have had heart problems (such as irregular heartbeat, chest pain during exercise, or coronary artery disease) – capecitabine can cause cardiotoxicity
  • You have brain disease (such as brain metastases) or nerve damage (neuropathy)
  • You have calcium imbalance – this can be detected through blood tests
  • You have diabetes – blood sugar monitoring may need to be more frequent
  • You are unable to keep food or water down due to severe nausea and vomiting
  • You have diarrhea or are at risk of dehydration
  • You have electrolyte imbalances (detectable in blood tests)
  • You have had eye problems previously – additional eye monitoring may be required
  • You have had a severe skin reaction to any medicine

Pregnancy and breastfeeding

Capecitabine Accord must not be taken during pregnancy, as it can cause serious harm to an unborn baby. If you are pregnant, think you might be pregnant, or are planning to become pregnant, speak with your doctor before using this medicine. You must also not breastfeed while taking Capecitabine Accord and for 2 weeks after the last dose.

Contraception requirements:

  • Women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose
  • Male patients with female partners of childbearing potential must use effective contraception during treatment and for 3 months after the last dose

Children and adolescents

Capecitabine Accord is not indicated for use in children and adolescents. Do not give this medicine to anyone under 18 years of age.

Driving and using machines

Capecitabine Accord may cause dizziness, nausea, or fatigue, which could impair your ability to drive or operate machinery safely. Do not drive or use machines if you experience these effects after taking this medicine.

Excipient information

Capecitabine Accord tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The tablets also contain less than 1 mmol (23 mg) sodium per tablet, meaning they are essentially sodium-free.

How Does Capecitabine Accord Interact with Other Drugs?

Capecitabine Accord has several clinically important drug interactions. The most dangerous is with brivudine (an antiviral), which is absolutely contraindicated and can be fatal. Warfarin effects may be significantly enhanced, and phenytoin levels may rise. Always tell your doctor about all medicines you are taking.

Drug interactions are a critical safety concern with capecitabine. Before starting treatment, tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. This includes prescription medicines, over-the-counter products, and herbal supplements. Taking more than one medicine at the same time can strengthen or weaken the effects of the individual medicines, sometimes with dangerous consequences.

Fatal Interaction: Brivudine

You must never take brivudine (an antiviral medicine for treating shingles or chickenpox) at the same time as capecitabine, including during rest periods when you are not taking capecitabine tablets. This combination can be fatal due to inhibition of the DPD enzyme by brivudine. If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting capecitabine treatment.

Important Drug Interactions with Capecitabine Accord
Interacting Drug Type of Interaction Clinical Effect Action Required
Brivudine Contraindicated Inhibits DPD enzyme, causing fatal 5-FU accumulation Absolutely contraindicated; wait 4 weeks after stopping brivudine
Warfarin / Coumarins Major Significantly increased anticoagulant effect; risk of bleeding Frequent INR monitoring; dose adjustment likely needed
Phenytoin Major Increased phenytoin blood levels; risk of toxicity Monitor phenytoin levels closely
Allopurinol Moderate May reduce the efficacy of capecitabine Avoid concomitant use if possible
Interferon alfa Moderate Potential increase in capecitabine toxicity Use with caution; monitor closely
Oxaliplatin / Cisplatin Expected combination Additive toxicity in combination chemotherapy Monitor per oncology protocol; dose adjustments per guidelines
Bevacizumab Expected combination Combined regimen for colorectal cancer Monitor per oncology protocol
Folinic acid (Leucovorin) Moderate Enhances both efficacy and toxicity of capecitabine Dose adjustment may be necessary

When stopping capecitabine treatment, be aware that if you are taking coumarin anticoagulants (such as warfarin), your doctor may need to readjust your anticoagulant dosage, as the enhanced anticoagulant effect may persist for some time after discontinuation.

Food interactions

Capecitabine Accord should be taken within 30 minutes after finishing a meal. Taking capecitabine with food reduces its rate of absorption but does not significantly affect the overall extent of absorption. The manufacturer recommends taking it with food to maintain consistent blood levels and reduce gastrointestinal side effects.

What Is the Correct Dosage of Capecitabine Accord?

The standard dosage of Capecitabine Accord for adults is 1250 mg/m² body surface area taken twice daily (morning and evening), within 30 minutes after meals. Treatment follows a 21-day cycle: 14 days on treatment followed by 7 days of rest. Your oncologist will calculate your exact dose based on your height, weight, and clinical status.

Always take Capecitabine Accord exactly as your doctor or pharmacist has told you. This medicine should only be prescribed by a doctor experienced in the use of anticancer medicines. Your doctor will prescribe the correct dose and dosing schedule for you, taking into account factors including your body surface area, the type of cancer being treated, whether the medicine is used alone or in combination, and your kidney and liver function.

Adults – Standard dosing

Monotherapy or adjuvant therapy

Dose: 1250 mg/m² body surface area, taken twice daily (morning and evening)

Schedule: 14 days on treatment, followed by 7 days of rest (21-day cycle)

Administration: Taken within 30 minutes after a meal, swallowed whole with water

Combination therapy

Dose: May be lower than 1250 mg/m², as directed by your oncologist

Schedule: May vary from standard 14/7 cycle depending on the combination regimen

Note: When used with other anticancer agents, your doctor will determine the appropriate dose and timing

The dose of Capecitabine Accord is calculated based on your body surface area (BSA), which is determined from your height and weight. For example:

Example Dosing Based on Body Surface Area
Weight Height BSA Dose per administration
64 kg 164 cm 1.7 m² 4 × 500 mg + 1 × 150 mg (2150 mg)
80 kg 180 cm 2.0 m² 5 × 500 mg (2500 mg)

Your doctor may prescribe a combination of 150 mg and 500 mg tablets for each dosing occasion to achieve the correct total dose. It is important to take exactly the combination of tablets your doctor has prescribed.

How to take the tablets

  • Take the tablets morning and evening as prescribed by your doctor
  • Take the tablets within 30 minutes after finishing a meal (breakfast and dinner)
  • Swallow the tablets whole with water – do not crush, chew, or split them
  • If you cannot swallow the tablets whole, talk to your healthcare provider about alternatives
  • It is important that you take all medicines as prescribed by your doctor

Children

Capecitabine Accord is not indicated for use in children and adolescents under 18 years of age. This medicine should not be given to pediatric patients.

Elderly patients

No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to side effects. Your doctor will monitor you closely and may adjust the dose if necessary, particularly if you have reduced kidney function, which is more common in older patients.

Missed dose

If you forget to take a dose of Capecitabine Accord, do not take the missed dose. Do not take a double dose to make up for a forgotten dose. Simply continue with your regular prescribed schedule and talk to your doctor about the missed dose at your next appointment.

Overdose

If you have taken too much Capecitabine Accord, contact your doctor immediately before taking your next dose. An overdose may cause the following symptoms: nausea, vomiting, diarrhea, inflammation or ulceration of the stomach or mouth, pain or bleeding from the intestines, or bone marrow depression (reduction in certain types of blood cells). Tell your doctor immediately if you experience any of these symptoms.

Stopping treatment

There are no specific side effects caused by stopping Capecitabine Accord treatment. However, if you are taking coumarin anticoagulants (such as warfarin), your doctor may need to adjust your anticoagulant dosage when you stop capecitabine. Do not stop treatment without consulting your oncologist, as premature discontinuation may affect your cancer treatment outcomes.

What Are the Side Effects of Capecitabine Accord?

Like all chemotherapy medicines, Capecitabine Accord can cause side effects. The most common include diarrhea, nausea, vomiting, mouth sores (stomatitis), hand-foot syndrome, rash, fatigue, and loss of appetite. Some side effects can be serious and require immediate medical attention. If caught early, most side effects resolve within 2–3 days after stopping treatment.

It is very important to recognize side effects early, as prompt management can prevent them from becoming severe. Your oncologist will give you specific instructions about when to stop taking capecitabine and when to contact them urgently. Following these instructions carefully is essential for your safety during treatment.

Stop Capecitabine Accord Immediately and Contact Your Doctor If You Experience:
  • Diarrhea: An increase of more than 4 bowel movements per day compared to your normal, or any nighttime diarrhea
  • Vomiting: More than once in a 24-hour period
  • Nausea: Loss of appetite with significantly reduced food intake
  • Stomatitis: Pain, redness, swelling, or sores in your mouth and/or throat
  • Hand-foot syndrome: Pain, swelling, redness, or tingling in your hands and/or feet
  • Fever: Body temperature of 38°C (100.4°F) or higher
  • Infection: Signs of bacterial, viral, or fungal infection
  • Chest pain: Especially pain that occurs during exercise
  • Stevens-Johnson syndrome: Painful red or purple skin rash that spreads, with blisters
  • Angioedema: Swelling of face, lips, tongue, or throat causing difficulty swallowing or breathing

If these side effects are detected early, they usually resolve within 2 to 3 days after treatment is stopped. If they continue, contact your doctor immediately. Your doctor may instruct you to restart treatment at a lower dose.

Very Common Side Effects

Affects more than 1 in 10 people
  • Diarrhea
  • Nausea
  • Vomiting
  • Stomatitis (mouth sores)
  • Hand-foot syndrome (palmar-plantar erythrodysesthesia)
  • Abdominal pain
  • Skin rash
  • Dry or itchy skin
  • Fatigue
  • Loss of appetite (anorexia)

Common Side Effects

Affects 1 in 10 to 1 in 100 people
  • Decreased white or red blood cells (shown in blood tests)
  • Dehydration, weight loss
  • Insomnia, depression
  • Headache, drowsiness, dizziness, numbness or tingling, taste changes
  • Eye irritation, increased tear production, red eyes (conjunctivitis)
  • Vein inflammation (thrombophlebitis)
  • Shortness of breath, nosebleeds, cough, runny nose
  • Cold sores, lung or respiratory infections
  • Intestinal bleeding, constipation, upper abdominal pain, indigestion, flatulence, dry mouth
  • Hair loss (alopecia), skin redness, nail changes, skin inflammation
  • Joint pain, limb pain, back pain, chest pain
  • Fever, swelling of limbs, general malaise
  • Liver function changes (shown in blood tests), increased bilirubin

Uncommon Side Effects

Affects 1 in 100 to 1 in 1,000 people
  • Blood infections, urinary tract infections, skin infections, fungal infections, influenza
  • Decreased platelets, thinned blood
  • Allergic reactions, diabetes, malnutrition, elevated blood lipids
  • Confusion, panic attacks, low mood, decreased libido
  • Speech difficulties, memory impairment, loss of coordination, fainting, nerve damage
  • Blurred or double vision, vertigo, ear pain
  • Irregular heartbeat, palpitations, chest pain, heart attack
  • Deep vein thrombosis, high or low blood pressure, hot flushes
  • Pulmonary embolism, collapsed lung, coughing up blood, asthma
  • Bowel obstruction, abdominal fluid accumulation, inflammation of the small intestine, colon, stomach, or esophagus
  • Jaundice (yellowing of skin and eyes)
  • Skin ulcers, photosensitivity, facial swelling or pain
  • Swollen or stiff joints, bone pain, muscle weakness or stiffness
  • Kidney fluid accumulation, urinary incontinence, blood in urine

Rare and Very Rare Side Effects

Affects fewer than 1 in 1,000 people
  • Tear duct narrowing or blockage (lacrimal duct stenosis)
  • Liver failure
  • Cholestatic hepatitis (bile duct inflammation)
  • QT prolongation on ECG, ventricular fibrillation, torsade de pointes, bradycardia
  • Eye inflammation with pain and possible vision problems
  • Skin inflammation with red, scaly patches (immune-mediated)
  • Angioedema (swelling of face, lips, tongue, or throat)
  • Severe skin reactions including ulcers and blisters affecting mouth, nose, genitals, hands, feet, and eyes (very rare)
Additional side effects in combination therapy

When capecitabine is used with other anticancer medicines, additional side effects may occur more frequently. These can include: decreased sodium, magnesium, or calcium levels in blood; increased blood sugar; nerve pain; tinnitus or hearing loss; vein inflammation; hiccups; voice changes; mouth or jaw pain; sweating and night sweats; muscle cramps; difficulty urinating; blood or protein in urine; and bruising or reactions at injection sites.

Hand-foot syndrome (palmar-plantar erythrodysesthesia) is one of the most characteristic side effects of capecitabine. It typically begins with tingling, numbness, or a burning sensation on the palms of the hands and soles of the feet. This can progress to pain, swelling, redness, and in severe cases, blistering and peeling. Early recognition and dose modification are key to managing this side effect. Skin reactions on hands and feet may lead to loss of fingerprints, which can affect fingerprint identification at security checkpoints.

How Should You Store Capecitabine Accord?

Store Capecitabine Accord out of the sight and reach of children. For aluminium-aluminium blisters, no special storage conditions are required. For PVC/PVdC-aluminium blisters, store below 30°C. Do not use after the expiry date printed on the packaging.

Proper storage of chemotherapy medicines is essential for maintaining their effectiveness and safety. Capecitabine Accord should be stored in its original packaging to protect it from moisture and light.

  • Aluminium-aluminium blisters: No special storage conditions are required
  • PVC/PVdC-aluminium perforated unit-dose blisters: Store at or below 30°C (86°F)
  • Keep out of the sight and reach of children
  • Do not use after the expiry date stated on the carton and blister pack
  • Do not throw away unused medicine in wastewater or household waste – ask your pharmacist how to properly dispose of medicines you no longer use, as chemotherapy drugs require special disposal to protect the environment
Safe handling of chemotherapy tablets

Although capecitabine tablets are film-coated, it is good practice to wash your hands thoroughly after handling them. If a tablet breaks or crumbles, avoid direct skin contact with the powder and clean up the area thoroughly. Caregivers who handle the tablets should consider wearing disposable gloves.

What Does Capecitabine Accord Contain?

The active substance in Capecitabine Accord is capecitabine, available in 150 mg, 300 mg, and 500 mg film-coated tablets. Inactive ingredients include anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate, and film-coating agents.

Active ingredient

  • Capecitabine 150 mg: Each film-coated tablet contains 150 mg capecitabine
  • Capecitabine 300 mg: Each film-coated tablet contains 300 mg capecitabine
  • Capecitabine 500 mg: Each film-coated tablet contains 500 mg capecitabine

Inactive ingredients (excipients)

Tablet core: Anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.

Film coating (150 mg): Hypromellose, titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc.

Film coating (300 mg): Hypromellose, titanium dioxide (E171), talc.

Film coating (500 mg): Hypromellose, titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc.

Appearance and pack sizes

Capecitabine Accord Tablet Identification
Strength Color Shape Dimensions Imprint
150 mg Peach Oblong, biconvex 11.4 mm × 5.3 mm "150" on one side
300 mg White to off-white Oblong, biconvex 14.6 mm × 6.7 mm "300" on one side
500 mg Peach Oblong, biconvex 15.9 mm × 8.4 mm "500" on one side

Capecitabine Accord is available in blister packs containing 30, 60, or 120 film-coated tablets, or in perforated unit-dose blister packs containing 30 × 1, 60 × 1, or 120 × 1 film-coated tablets. Not all pack sizes may be marketed in all countries.

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, Spain.

Frequently Asked Questions About Capecitabine Accord

Capecitabine Accord is used to treat several types of cancer: colon cancer (including adjuvant therapy after surgery to prevent recurrence), rectal cancer, gastric (stomach) cancer, and breast cancer. It can be used alone or in combination with other anticancer medicines, depending on the type and stage of cancer. Your oncologist will determine the most appropriate use for your specific clinical situation.

The most common side effects (affecting more than 1 in 10 patients) include diarrhea, nausea, vomiting, mouth sores (stomatitis), hand-foot syndrome (pain, redness, and swelling of hands and feet), abdominal pain, skin rash, dry or itchy skin, fatigue, and loss of appetite. Most side effects are manageable with dose adjustments and supportive care. Contact your doctor immediately if side effects become severe.

DPD (dihydropyrimidine dehydrogenase) is the main enzyme responsible for breaking down fluoropyrimidine medicines like capecitabine. Some people have a genetic deficiency of this enzyme. Patients with complete DPD deficiency cannot safely metabolize capecitabine and may experience life-threatening or fatal toxicity. Patients with partial deficiency may require dose reductions. Testing before treatment allows your doctor to identify potential problems and adjust treatment accordingly.

No, Capecitabine Accord should be taken within 30 minutes after finishing a meal. The manufacturer recommends taking it after breakfast and dinner. Taking it with food helps maintain consistent drug levels and may reduce gastrointestinal side effects. Swallow the tablets whole with water – do not crush or split them.

If you forget to take a dose, do not take the missed dose and do not double up on your next dose. Simply continue with your regular dosing schedule. Inform your doctor about the missed dose at your next appointment. It is important to maintain your prescribed schedule as closely as possible, but never try to compensate for a missed dose by taking extra tablets.

Hand-foot syndrome (palmar-plantar erythrodysesthesia) is a common side effect of capecitabine that causes tingling, numbness, pain, redness, and swelling of the palms and soles. In severe cases, blisters and peeling may occur. Management includes moisturizing creams, avoiding hot water and friction, and wearing comfortable shoes. If symptoms become moderate or severe, your doctor will likely reduce your dose or pause treatment. Early reporting is important to prevent progression. Note that this side effect may cause temporary loss of fingerprints.

References

  1. European Medicines Agency (EMA). Capecitabine – Summary of Product Characteristics. Available at: www.ema.europa.eu. Last accessed January 2026.
  2. World Health Organization. WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
  3. Twelves C, Wong A, Nowacki MP, et al. Capecitabine as Adjuvant Treatment for Stage III Colon Cancer. N Engl J Med. 2005;352(26):2696-2704. doi:10.1056/NEJMoa043116
  4. Walko CM, Lindley C. Capecitabine: A review. Clin Ther. 2005;27(1):23-44. doi:10.1016/j.clinthera.2005.01.005
  5. 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 Oncol. 2018;19(11):1459-1467. doi:10.1016/S1470-2045(18)30686-7
  6. ESMO Clinical Practice Guidelines: Cancer of the Colon. Annals of Oncology. Updated 2024.
  7. British National Formulary (BNF). Capecitabine. Available at: bnf.nice.org.uk. Last accessed January 2026.
  8. U.S. Food and Drug Administration (FDA). Xeloda (capecitabine) Prescribing Information. Reference ID: 4968981.
  9. Deenen MJ, Meulendijks D, Cats A, et al. Upfront Genotyping of DPYD*2A to Individualise Fluoropyrimidine Therapy: A Safety and Cost Analysis. J Clin Oncol. 2016;34(3):227-234.
  10. Cassidy J, Twelves C, Van Cutsem E, et al. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol. 2002;13(4):566-575.

About Our Medical Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, which includes specialists in oncology and clinical pharmacology. All medical content is based on current international guidelines and peer-reviewed research.

Evidence Standards

  • Evidence Level 1A (systematic reviews, RCTs)
  • GRADE evidence framework
  • Regular updates per guideline changes

Guideline Sources

  • European Medicines Agency (EMA)
  • U.S. FDA Prescribing Information
  • WHO Essential Medicines List
  • ESMO Clinical Practice Guidelines
  • British National Formulary (BNF)

Conflict of Interest Statement: iMedic receives no pharmaceutical funding. All content is independently written and reviewed. We maintain strict editorial independence from industry influence.