Ecansya (Capecitabine): Uses, Dosage & Side Effects
Oral chemotherapy for colon, rectal, gastric, and breast cancer
Quick Facts About Ecansya (Capecitabine)
Key Takeaways About Ecansya
- Oral chemotherapy prodrug: Ecansya (capecitabine) is converted to active 5-FU preferentially in tumor tissue, providing targeted anticancer activity with oral convenience
- DPD testing is critical: Patients must be tested for DPD (dihydropyrimidine dehydrogenase) deficiency before starting treatment, as complete DPD deficiency can cause fatal toxicity
- Never combine with brivudine: A minimum 4-week gap after stopping brivudine is required before starting capecitabine due to potentially fatal interaction
- Cycle-based dosing: Standard treatment involves 14 days of twice-daily tablets followed by a 7-day rest period (21-day cycle)
- Monitor for side effects: Stop treatment immediately and contact your doctor if you develop severe diarrhea, vomiting, mouth sores, hand-foot syndrome, or fever
What Is Ecansya and What Is It Used For?
Ecansya is an oral chemotherapy medication containing capecitabine, a fluoropyrimidine prodrug that belongs to a group of medicines called antimetabolites. Once absorbed by the body, capecitabine is converted to the active anticancer agent 5-fluorouracil (5-FU), preferentially in tumor tissue, where it inhibits cancer cell growth and division.
Unlike traditional intravenous chemotherapy, Ecansya offers the convenience of oral administration while maintaining comparable efficacy. The active substance, capecitabine, is not directly cytotoxic. Instead, it undergoes a three-step enzymatic activation process in the body. The final conversion to 5-FU occurs through the enzyme thymidine phosphorylase, which is present at significantly higher concentrations in tumor tissue compared to normal healthy tissue. This preferential activation means that higher concentrations of 5-FU are generated within tumors, potentially reducing systemic toxicity while maintaining anticancer effectiveness.
Ecansya is approved for use in several types of cancer. It is used to treat colon cancer (including as adjuvant therapy after surgical removal of the tumor to reduce the risk of recurrence), rectal cancer, gastric (stomach) cancer, and metastatic breast cancer. In colon and rectal cancer, capecitabine has become one of the most widely used oral chemotherapy agents worldwide, supported by large randomized controlled trials demonstrating non-inferiority to intravenous 5-FU/leucovorin regimens.
Ecansya can be used as monotherapy (single agent) or in combination with other anticancer medications depending on the type and stage of cancer being treated. Common combination regimens include capecitabine with oxaliplatin (CAPOX/XELOX) for colorectal cancer, capecitabine with docetaxel for breast cancer, and capecitabine with cisplatin or epirubicin for gastric cancer. Your oncologist will determine the most appropriate treatment plan based on your individual clinical situation.
What Should You Know Before Taking Ecansya?
Before starting Ecansya, it is essential to undergo DPD deficiency testing, inform your doctor about all medical conditions and medications, and understand the contraindications. Patients with complete DPD deficiency, severe liver or kidney disease, or those taking brivudine must not use Ecansya.
Contraindications
You must not take Ecansya in the following circumstances:
- Allergy to capecitabine or any other ingredient in the tablets (see the Ingredients section below)
- Previous severe reactions to fluoropyrimidine therapy (a group of anticancer drugs such as fluorouracil)
- Complete DPD deficiency (absence of the enzyme dihydropyrimidine dehydrogenase) – this can cause severe, life-threatening toxicity
- Pregnancy or breastfeeding
- Severe low white blood cell or platelet counts (leukopenia, neutropenia, or thrombocytopenia)
- Severe liver or kidney disease
- Treatment with brivudine (an antiviral for herpes zoster) within the last 4 weeks
Warnings and Precautions
Speak with your doctor or pharmacist before taking Ecansya if any of the following apply to you:
- Known partial DPD deficiency or family history of DPD deficiency
- Liver or kidney disease
- Heart problems, including irregular heartbeat, chest pain, or angina
- Brain disease (such as brain metastases) or nerve damage (neuropathy)
- Calcium imbalances (detected on blood tests)
- Diabetes mellitus
- Severe nausea and vomiting preventing you from keeping food or water down
- Diarrhea
- Dehydration or electrolyte imbalances
- Previous eye problems
- History of severe skin reactions
DPD (dihydropyrimidine dehydrogenase) deficiency is a genetic condition that is usually asymptomatic unless you take certain medications. If you have DPD deficiency and take Ecansya, you have a significantly increased risk of severe, life-threatening, or fatal side effects including severe stomatitis, mucosal inflammation, diarrhea, neutropenia, and neurotoxicity. Testing for DPD deficiency is recommended before starting treatment. Patients with complete DPD deficiency must never take capecitabine. If you have partial DPD deficiency, your doctor may prescribe a reduced dose. Serious side effects can still occur even if your DPD test result is negative.
Pregnancy, Breastfeeding, and Fertility
Ecansya must not be taken during pregnancy, as it can cause harm to the developing baby. If you are pregnant, think you may be pregnant, or are planning to become pregnant, speak with your doctor before taking this medication. You must also not breastfeed while taking Ecansya and for 2 weeks after the last dose.
Women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose. Male patients whose female partner is of childbearing potential must use effective contraception during treatment and for 3 months after the last dose.
Children and Adolescents
Ecansya is not indicated for use in children or adolescents. Do not give this medication to anyone under 18 years of age.
Driving and Operating Machinery
Ecansya may cause dizziness, nausea, or tiredness. If you experience any of these effects, do not drive or operate machinery until the symptoms resolve. These effects are particularly important to consider during the active treatment days of each cycle.
How Does Ecansya Interact with Other Drugs?
Ecansya has several clinically significant drug interactions. The most dangerous is with brivudine, which is contraindicated and can be fatal. Warfarin effects may be substantially increased, and phenytoin levels can rise significantly. Always inform your healthcare provider about all medications you are currently taking.
Drug interactions with capecitabine can be severe and sometimes life-threatening. It is essential to tell your doctor, oncologist, or pharmacist about all medications you are taking, have recently taken, or might take, including over-the-counter drugs, herbal supplements, and vitamins. Some interactions can change how well Ecansya works or increase the risk of dangerous side effects.
Major Interactions
| Drug | Interaction | Clinical Significance |
|---|---|---|
| Brivudine (antiviral) | Inhibits DPD enzyme, preventing capecitabine breakdown | CONTRAINDICATED – Potentially fatal. Must wait at least 4 weeks after stopping brivudine before starting capecitabine. |
| Warfarin / Coumarin anticoagulants | Capecitabine potentiates the anticoagulant effect, increasing INR | Increased risk of severe bleeding. Requires frequent INR monitoring and warfarin dose adjustments during and after treatment. |
| Phenytoin (antiepileptic) | Capecitabine increases phenytoin plasma levels | Risk of phenytoin toxicity (ataxia, nystagmus, drowsiness). Regular monitoring of phenytoin levels recommended. |
| Allopurinol (gout treatment) | May reduce capecitabine efficacy | Potential reduction in anticancer effect. Discuss alternatives with your doctor. |
Combination Therapy Interactions
When Ecansya is used in combination with other anticancer treatments, additional interactions and increased toxicity may occur:
- Folinic acid (leucovorin): Enhances the toxicity of capecitabine; dose adjustments may be needed
- Oxaliplatin: Used in combination (CAPOX regimen) for colorectal cancer; increases risk of neuropathy and diarrhea
- Bevacizumab: Combined for metastatic colorectal cancer; monitor for increased toxicity
- Cisplatin: Used together for gastric cancer; increases risk of renal toxicity and myelosuppression
- Irinotecan: Combined treatment increases risk of severe diarrhea and neutropenia
- Interferon alfa: May increase capecitabine toxicity
- Radiotherapy: Capecitabine can enhance the effects and toxicity of radiation therapy
What Is the Correct Dosage of Ecansya?
The standard adult dose of Ecansya is 1,250 mg/m² body surface area taken twice daily (morning and evening) for 14 days, followed by a 7-day rest period. This 21-day cycle is repeated as directed by your oncologist. The dose is individually calculated based on your height and weight.
Capecitabine must only be prescribed by a doctor experienced in the use of anticancer medicines. Your doctor will calculate the correct dose based on your body surface area (BSA), which is derived from your height and weight. The tablets should be swallowed whole with water within 30 minutes after completing a meal. Do not crush, chew, or split the tablets. If you cannot swallow them whole, speak with your healthcare provider about alternatives.
Adults – Standard Dosing
Monotherapy (single agent)
Dose: 1,250 mg/m² twice daily (morning and evening)
Schedule: 14 days on treatment, followed by 7 days rest (21-day cycle)
Administration: Take within 30 minutes after a meal, swallow whole with water
Combination therapy
Dose: May be lower than 1,250 mg/m² depending on the combination regimen
Schedule: May vary – some combinations require daily dosing without rest periods
Note: Your doctor will provide specific instructions for your combination regimen
Dosing Examples by Body Surface Area
| Weight | Height | BSA | Dose Per Intake | Tablets Per Intake |
|---|---|---|---|---|
| 64 kg | 164 cm | 1.7 m² | 2,150 mg | 4 × 500 mg + 1 × 150 mg |
| 80 kg | 180 cm | 2.0 m² | 2,500 mg | 5 × 500 mg |
Your doctor may prescribe a combination of 150 mg and 500 mg tablets for each dose to achieve the correct total amount. The available tablet strengths (150 mg and 500 mg) allow for flexible dosing to closely match the calculated dose for your body surface area.
Children
Ecansya is not approved for use in children and adolescents. There are no established dosing recommendations for patients under 18 years of age.
Elderly Patients
No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to certain side effects, and your doctor may consider starting at a lower dose or monitoring you more closely. Kidney function should be assessed, as age-related decline in renal function may affect capecitabine clearance.
Dose Adjustments for Kidney or Liver Impairment
Patients with mild to moderate kidney impairment may require dose reductions. Patients with severe kidney or liver impairment should not take Ecansya. Your doctor will assess your kidney and liver function through blood tests before and during treatment to determine if dose adjustments are necessary.
Missed Dose
If you forget to take a dose of Ecansya, do not take the missed dose. Do not take a double dose to make up for the forgotten one. Simply continue with your regular dosing schedule and inform your doctor at your next appointment. Consistency in dosing is important for treatment effectiveness, but taking extra tablets can increase the risk of serious side effects.
Overdose
If you have taken more Ecansya than prescribed, contact your doctor immediately before taking the next dose. Symptoms of overdose may include nausea, vomiting, diarrhea, inflammation or ulcers in the mouth or intestines, pain or bleeding from the intestines or stomach, and bone marrow depression (reduced blood cell counts). Emergency supportive care may be required.
Stopping Treatment
There are no specific withdrawal effects when stopping capecitabine. However, if you are also taking coumarin anticoagulants (such as warfarin), your doctor may need to adjust your anticoagulant dose when you stop capecitabine, as the interaction effect will gradually diminish. Never stop treatment without consulting your oncologist, as premature discontinuation may affect treatment outcomes.
What Are the Side Effects of Ecansya?
Like all chemotherapy medicines, Ecansya can cause side effects. The most common include diarrhea, nausea, vomiting, mouth sores (stomatitis), hand-foot syndrome, fatigue, abdominal pain, skin rash, and loss of appetite. You should stop taking Ecansya immediately and contact your doctor if you experience any severe side effects.
- Severe diarrhea: More than 4 additional bowel movements per day compared to your normal pattern, or any nighttime diarrhea
- Vomiting: More than once in 24 hours
- Significant appetite loss: Unable to eat your normal amount of food
- Stomatitis: Pain, redness, swelling, or sores in the mouth and/or throat
- Hand-foot syndrome: Pain, swelling, redness, or tingling in hands and/or feet
- Fever: Temperature of 38°C (100.4°F) or higher
- Signs of infection: Any symptoms of bacterial, viral, or fungal infection
- Chest pain: Especially during physical activity
- Stevens-Johnson syndrome: Painful red or purple skin rash with blisters and sores in mucous membranes
- Angioedema: Swelling of face, lips, tongue, or throat causing difficulty swallowing or breathing
If side effects are detected early and treatment is stopped promptly, most will resolve within 2–3 days. If they persist, contact your doctor immediately. Your doctor may advise resuming treatment at a lower dose to reduce the risk of recurrence.
Side Effects When Used as Monotherapy
Very Common
- 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
- Decreased white or red blood cells (seen on blood tests)
- Dehydration, weight loss
- Insomnia, depression, headache, drowsiness, dizziness
- Numbness or tingling (paresthesia), taste changes
- Eye irritation, increased tearing, conjunctivitis
- Vein inflammation (thrombophlebitis)
- Shortness of breath, nosebleeds, cough, runny nose
- Cold sores or other herpes infections
- Lung or respiratory tract infections (pneumonia, bronchitis)
- Intestinal bleeding, constipation, upper abdominal pain, indigestion, dry mouth
- Hair loss (alopecia), skin redness, skin discoloration, nail changes
- Joint pain, pain in extremities, chest, or back
- Fever, swelling in extremities, malaise
- Abnormal liver function tests, increased bilirubin
Uncommon
- Blood infections (sepsis), urinary tract infections, skin infections
- Decreased platelet count, blood thinning
- Allergic reactions, diabetes, decreased potassium
- Confusion, panic attacks, depression, decreased libido
- Speech difficulties, memory impairment, coordination problems, fainting
- Blurred or double vision, dizziness, ear pain
- Irregular heartbeat (arrhythmias), chest pain, heart attack
- Deep vein thrombosis, high or low blood pressure
- Pulmonary embolism, coughing up blood, asthma
- Bowel obstruction, abdominal fluid buildup, jaundice
- Skin blisters, sun sensitivity, facial swelling
- Joint swelling, bone pain, muscle weakness
- Kidney fluid retention, urinary incontinence, blood in urine
Rare
- Angioedema (swelling of face, lips, tongue, or throat)
- Tear duct narrowing or blockage (lacrimal duct stenosis)
- Liver failure
- Cholestatic hepatitis
- QT prolongation on ECG
- Ventricular fibrillation, torsade de pointes, bradycardia
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Additional Side Effects in Combination Therapy
When Ecansya is used together with other anticancer medications, additional side effects may occur or existing ones may become more frequent:
- Common (combination therapy): Decreased sodium, magnesium, or calcium in blood; nerve pain; tinnitus or hearing loss; vein inflammation; hiccups; voice changes; mouth pain or altered sensation; sweating and night sweats; muscle cramps; difficulty urinating; bruising at injection sites
- Rare (combination therapy): Eye inflammation causing pain and vision problems
How Should You Store Ecansya?
Store Ecansya 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 medications is essential for both safety and effectiveness. Follow these guidelines:
- Keep out of reach of children – this is especially critical for chemotherapy medicines
- Check the expiry date on the carton and blister pack (marked "EXP"). The expiry date refers to the last day of the stated month
- Aluminium-aluminium blisters: No special storage conditions are required
- PVC/PVdC-aluminium blisters: Store at or below 30°C (86°F)
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused or expired tablets to your pharmacy for safe disposal. This helps protect the environment and prevents accidental exposure
What Does Ecansya Contain?
Each Ecansya tablet contains either 150 mg or 500 mg of the active ingredient capecitabine. The tablets also contain inactive ingredients including lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, and magnesium stearate in the tablet core, with a film coating containing hypromellose, titanium dioxide, and iron oxides.
Active Ingredient
The active substance is capecitabine. Each film-coated tablet contains either 150 mg or 500 mg of capecitabine.
Inactive Ingredients (Excipients)
Tablet core: Lactose, croscarmellose sodium, hypromellose (E-5), microcrystalline cellulose, magnesium stearate.
Film coating:
- 150 mg tablets: Hypromellose (6cps), titanium dioxide (E171), yellow iron oxide, red iron oxide (E172), talc
- 500 mg tablets: Hypromellose (6cps), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Tablet Appearance and Pack Sizes
| Strength | Colour | Shape | Size | Marking |
|---|---|---|---|---|
| 150 mg | Light peach | Oblong, biconvex | 11.4 mm × 5.3 mm | "150" on one side |
| 500 mg | Peach | Oblong, biconvex | 15.9 mm × 8.4 mm | "500" on one side |
Ecansya is available in blister packs (aluminium-aluminium or PVC/PVdC-aluminium) containing 30, 60, or 120 film-coated tablets. Not all pack sizes may be marketed in your country.
Manufacturer: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
Frequently Asked Questions About Ecansya
Ecansya (capecitabine) is an oral chemotherapy medication used to treat several types of cancer including colon cancer, rectal cancer, gastric (stomach) cancer, and breast cancer. It is also used as adjuvant therapy after colon cancer surgery to reduce the risk of recurrence. Ecansya can be used alone or in combination with other anticancer drugs, depending on the type and stage of cancer.
The most common side effects (affecting more than 1 in 10 people) include diarrhea, nausea, vomiting, mouth sores (stomatitis), hand-foot syndrome (pain, redness, and swelling of palms and soles), abdominal pain, skin rash, dry or itchy skin, fatigue, and loss of appetite. If any of these become severe, you should stop treatment immediately and contact your doctor.
DPD (dihydropyrimidine dehydrogenase) is an enzyme that helps break down fluoropyrimidine drugs like capecitabine. Some people are born with reduced or absent DPD activity. Patients with complete DPD deficiency must never take Ecansya, as this can lead to severe, life-threatening toxicity. Testing for DPD deficiency is recommended before starting treatment. If you have partial deficiency, your doctor may prescribe a lower dose.
Yes, both Ecansya and Xeloda contain the same active ingredient – capecitabine – and are therapeutically equivalent. Xeloda is the originator brand manufactured by Roche, while Ecansya is a generic version manufactured by KRKA. Other generic versions include Capecitabine Teva and Capecitabine Sandoz. They all contain the same active substance and undergo rigorous regulatory approval processes to ensure comparable quality, safety, and efficacy.
Take Ecansya tablets twice daily, morning and evening, within 30 minutes after finishing a meal. Swallow the tablets whole with water – do not crush, chew, or split them. The standard cycle is 14 days of treatment followed by 7 days of rest (no tablets), repeated every 21 days. Your doctor will tell you exactly how many tablets to take at each dose based on your body surface area.
If you miss a dose of Ecansya, do not take the missed dose and do not take a double dose to make up for it. Simply continue with your next scheduled dose. Inform your oncologist about the missed dose at your next appointment. While consistency is important for treatment effectiveness, taking extra tablets increases the risk of serious side effects.
References & Sources
This article is based on the following peer-reviewed sources and authoritative medical guidelines:
- European Medicines Agency (EMA). Capecitabine – Summary of Product Characteristics (SmPC). EMA/CHMP approved product information. Available at: www.ema.europa.eu.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: World Health Organization. Capecitabine listed as essential antineoplastic agent.
- Twelves C, 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.
- Cassidy J, et al. XELOX (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer. Journal of Clinical Oncology. 2004;22(11):2084–2091.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines for diagnosis, treatment and follow-up of colorectal, gastric, and breast cancers. Published and updated regularly at www.esmo.org.
- Hoff PM, 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.
- EMA Pharmacovigilance Risk Assessment Committee (PRAC). Recommendations on DPD testing prior to treatment with fluoropyrimidines. April 2020.
- British National Formulary (BNF). Capecitabine – drug monograph. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk.
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of licensed specialist physicians in oncology, clinical pharmacology, and internal medicine with documented clinical and academic experience.
iMedic Medical Editorial Team – specialists in oncology and clinical pharmacology. All content follows international evidence-based guidelines (EMA, FDA, WHO, ESMO).
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All pharmaceutical information on iMedic is based on approved Summary of Product Characteristics (SmPC), peer-reviewed clinical trials, and international treatment guidelines. We maintain editorial independence with no commercial funding or pharmaceutical sponsorship. Evidence level: 1A – based on systematic reviews and meta-analyses of randomized controlled trials. Read more about our editorial standards.