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Capecitabine 500 mg

Medically reviewed by Sanjay Gangani, B.Pharm, CMO & Pharmacist

Active Ingredient Capecitabine
Indication Ovarian cancer, Head and neck cancer, Cervical cancer
Manufacturer American Remedies Pvt. Ltd
Strength:- 500mg
Packaging 10 tablets in 1 strip

Capecitabine 500 mg

Pack Size Price Price/unit Quantity Add To Cart
100 Tablet/s $70 $0.70/Pill
200 Tablet/s $130 $0.65/Pill
300 Tablet/s $185 $0.62/Pill

What is Capecitabine 500 mg

  • Capecitabine is an oral chemotherapy tablet.

  • It belongs to the fluoropyrimidine class.

  • It is a prodrug, meaning it is inactive as swallowed.

  • The body converts it into fluorouracil.

  • Fluorouracil is the drug that kills cancer cells.

  • The 500 mg tablet is the larger of two strengths.

  • A Xeloda tablet exists for fine dose adjustment.

  • It treats cancers of the bowel and rectum.

  • It treats breast, stomach and pancreatic cancers.

  • It is used alone or with other cancer drugs.

  • It is prescribed and supervised by a cancer specialist.

  • The original brand name is Xeloda.

  • Many Indian generic brands are also marketed.

Product identity

FieldDetail
Generic nameCapecitabine
Strength covered here500 mg per tablet
Other strength150 mg
Dosage formFilm-coated tablet, oral
Appearance of 500 mgPeach, oblong
Appearance of 150 mgLight peach, oblong
Drug classOral fluoropyrimidine, antimetabolite
Converts toFluorouracil, also called 5-FU
Usual frequencyTwice daily, about 12 hours apart
Cycle14 days on, 7 days off, in 21-day cycles
Reference brandXeloda
Indian brand checkedCapnat 500 mg, Natco Pharma Ltd
Pack checkedPack of 10 tablets
MRP of that packRs. 1,687.50, with an old MRP of Rs. 1,800
Prescription statusPrescription required
StorageBelow 30 degrees Celsius
Reference labels usedUS FDA Xeloda, an Indian generic PI, EMA

How it works (mechanism of action)

  • Capecitabine is swallowed in an inactive form.

  • Three enzyme steps turn it into fluorouracil.

  • Carboxylesterase makes the first change.

  • Cytidine deaminase makes the second.

  • Thymidine phosphorylase performs the final step.

  • That step releases the active drug, fluorouracil.

  • One study sampled tumour and nearby tissue.

  • The median tumour-to-tissue ratio was 2.9.

  • But the measured range ran from 0.9 to 8.0.

  • So the tumour advantage is not the same in everyone.

  • Both normal and tumour cells activate fluorouracil.

  • One active product blocks thymidylate synthase.

  • It does so with a folate cofactor, as a locked complex.

  • That blocks a base needed to build DNA.

  • Cell division is inhibited without that base.

  • Another active product is built into RNA instead of uracil.

  • That disrupts RNA processing and protein making.

  • Rapidly dividing cells are hit hardest.

  • That includes gut lining, bone marrow and skin.

  • That is why those tissues show the side effects.

  • A separate enzyme, DPD, clears fluorouracil away.

  • Low DPD activity lets it accumulate dangerously.

Dosage guide

Your oncologist sets your dose. These are the labelled regimens.

Approved regimens, all taken twice daily

SettingDose twice dailySchedule
Adjuvant colon, single agent1,250 mg/m2Days 1 to 14, 8 cycles
Adjuvant colon, with oxaliplatin1,000 mg/m2Days 1 to 14, 8 cycles
Rectal, with radiation825 mg/m2Perioperative
Rectal, without radiation1,250 mg/m2Perioperative
Metastatic colorectal, single agent1,250 mg/m2Days 1 to 14
Metastatic colorectal, with oxaliplatin1,000 mg/m2Days 1 to 14
Breast, single agent1,000 or 1,250 mg/m2Days 1 to 14
Breast, with docetaxel1,000 or 1,250 mg/m2Days 1 to 14
  • Every cycle lasts 21 days in total.

  • Days 15 to 21 are a rest period with no tablets.

  • Docetaxel is given at 75 mg/m2 on day one.

  • Oxaliplatin is given at 130 mg/m2 on day one.

  • Doses are never increased after a reduction.

  • Blood counts are checked before each cycle.

How to take it

  • Read the written dose on your prescription.

  • Count the tablets for one dose before each dose.

  • Eat a meal first, then take the tablets.

  • Take them within thirty minutes of finishing that meal.

  • Swallow them whole with a glass of water.

  • Never chew, break or crush a tablet.

  • Take the second dose about twelve hours later.

  • Keep to the same two clock times daily.

  • Take tablets on days one to fourteen only.

  • Take none during the seven rest days.

  • Do not replace a dose you vomited.

  • Wash your hands after handling the tablets.

  • Keep all blood test appointments.

  • Tell the clinic at once about diarrhoea or mouth ulcers.

  • Tell the clinic about sore, red or peeling palms.

  • Carry a card stating you take oral chemotherapy.

Precautions

Absolute contraindications

  • Severe hypersensitivity to capecitabine.

  • Severe hypersensitivity to fluorouracil.

  • Hypersensitivity to any component of the tablet.

  • Known complete DPD deficiency, as not recommended.

  • Severe kidney impairment, per the 2019 generic label.

  • Note the 2022 innovator label words that differently.

  • Pregnancy, because the drug can harm the baby.

Conditions to disclose to your doctor

  • Any known DPD deficiency in you or your family.

  • Any severe reaction to past fluorouracil treatment.

  • Any kidney disease, and your creatinine clearance.

  • Any liver disease or raised bilirubin.

  • Any heart disease, angina or rhythm problem.

  • Warfarin or any other blood thinner.

  • Phenytoin or any other epilepsy medicine.

  • Allopurinol taken for gout.

  • Any folic acid or leucovorin product.

  • Diabetes and all its medicines.

  • Any other chemotherapy or radiotherapy planned.

  • Pregnancy, planned pregnancy or breastfeeding.

  • Your age, since those over 80 tolerate it less well.

  • All supplements, including vitamins.

Food and drink precautions

  • Every dose follows a meal within thirty minutes.

  • Do not take it on an empty stomach.

  • Use water, not juice, to swallow the tablets.

  • Avoid grapefruit while on treatment unless cleared.

  • Drink fluids steadily to protect the kidneys.

  • Diarrhoea and vomiting cause rapid dehydration.

  • Eat small, bland meals if your mouth is sore.

  • Avoid very hot, spicy or acidic food with mouth ulcers.

  • Do not take folic acid supplements unless prescribed.

  • Folate products may increase the drug toxicity.

  • Avoid alcohol, which worsens mouth and gut effects.

Before-use safety checklist

  • Confirm your cancer specialist prescribed it.

  • Ask whether you were tested for DPD deficiency.

  • Confirm your height and weight were measured.

  • Confirm the written dose in milligrams per dose.

  • Confirm how many 500 mg tablets that means.

  • Confirm how many 150 mg tablets to add.

  • Confirm which days of the cycle you take them.

  • Confirm the date the rest week begins.

  • Have baseline blood counts recorded.

  • Have kidney and liver function recorded.

  • Tell the team if you take warfarin.

  • Arrange more frequent INR tests if you do.

  • Arrange effective contraception if relevant.

  • Get the clinic emergency number in writing.

  • Agree which symptoms mean stopping the tablets.

Side effects

Rates differ by cancer and by whether other drugs are given.

Common side effects with reported rates

Side effectReported rateSevere grade 3 or 4
Hand and foot reaction54% to 63%11% to 24%
Diarrhoea47% to 67%12% to 14%
Mouth soreness, stomatitisUp to 67%17%
Nausea34% to 53%Not stated here
Fatigue16% to 42%Not stated here
Anaemia72% to 80%Not stated here
Low lymphocytesUp to 94%44%
Raised bilirubin48%18% grade 3, 5% grade 4
Hair loss41%Not stated here
  • Hand and foot reaction causes redness and soreness.

  • It can progress to peeling, blistering and pain.

  • It is a common reason for dose reduction.

  • Toxicity in the first cycle deserves urgent attention.

  • It can be the first sign of DPD deficiency.

Serious side effects

Side effectWhy it matters
Severe diarrhoeaCan be fatal, needs the drug withheld
Severe dehydrationCan cause acute kidney injury
NeutropeniaLow white cells, serious infection risk
ThrombocytopeniaLow platelets, bleeding risk
Bleeding with blood thinnersThe boxed warning, can be fatal
Early-onset severe toxicityMay indicate DPD deficiency
MucositisSevere mouth and gut lining damage
NeurotoxicityReported in DPD deficiency
Cardiac effectsChest pain and rhythm changes reported
Severe skin reactionsBlistering or peeling rash
Raised bilirubin and liver injuryNeeds dose interruption

Drug interactions – avoid with

Drug or groupWhat happens and what to do
Warfarin and vitamin K antagonistsBleeding risk, monitor INR often
AllopurinolAvoid, it may reduce the drug effect
Leucovorin and folate productsMay raise toxicity, monitor closely
Folic acid supplementsDo not take unless prescribed
PhenytoinLevels rise, monitor and adjust the dose
Other CYP2C9 substratesMonitor closely
Antidiabetic drugsEffects may change, monitor sugar
Platinum salts such as cisplatinWatch for kidney toxicity
IrinotecanWatch for kidney toxicity
MethotrexateWatch for kidney toxicity
Intravenous bisphosphonatesWatch for kidney toxicity
Other fluoropyrimidinesNever combine, overlapping toxicity
Live vaccinesDiscuss timing with the oncology team

Emergency warning signs

  • Stop the tablets and contact the clinic at once.

  • Four or more loose stools above your normal daily count.

  • Any diarrhoea at night.

  • Diarrhoea you cannot control with fluids.

  • Vomiting more than once in twenty-four hours.

  • Inability to eat or drink because of mouth pain.

  • Mouth ulcers that stop you swallowing.

  • Pain in the hands or feet that limits walking.

  • A temperature of 38 degrees Celsius or above.

  • Shivering, shaking or any sign of infection.

  • Unusual bruising or any bleeding.

  • Blood in the stool, urine or vomit.

  • Yellow eyes or skin, or dark urine.

  • Chest pain, palpitations or breathlessness.

  • Say you are taking oral capecitabine chemotherapy.

  • State your dose, your cycle day and the start date.

  • Fever on chemotherapy is treated as an emergency.

  • Do not wait for the next scheduled appointment.

Why choose this medicine

  • It is taken at home as a tablet.

  • It avoids repeated infusion appointments.

  • It avoids the need for an infusion line or port.

  • It delivers fluorouracil without a drip.

  • Tumour fluorouracil levels often exceed nearby tissue.

  • It is approved across several common cancers.

  • It works alone or with other cancer drugs.

  • It is used both to cure and to control disease.

  • Generic versions are made in India.

  • That lowers cost compared with the original brand.

Reasons it needs great care

  • It is full chemotherapy, not a mild tablet.

  • Home dosing puts the schedule in your hands.

  • A dosing error is not caught by a nurse.

  • DPD deficiency can make it life-threatening.

  • It carries a boxed warning about blood thinners.

  • Hand and foot reactions are common and painful.

  • Diarrhoea can be severe and sometimes fatal.

  • It requires regular blood tests throughout.

  • The cost of a full course is substantial.

Storage instructions

  • Store below 30 degrees Celsius.

  • Keep in a cool, dry place.

  • Keep away from heat and direct light.

  • Keep the tablets in their original pack.

  • Keep the pack tightly closed.

  • Do not store in a bathroom cabinet.

  • Keep well out of reach of children.

  • Store it apart from other household medicines.

  • Handle it as a hazardous drug at all times.

  • Do not transfer tablets into a pill organiser.

  • Check the expiry date before each cycle.

  • Return unused tablets to the hospital pharmacy.

  • Do not flush them or bin them at home.

Sanjay Gangani

Sanjay Gangani

B.Pharm, CMO & Pharmacist

Licensed pharmacist (B.Pharm) with 12+ years in clinical pharmacy and patient care. Reviews every article for evidence-based accuracy before it is published on ACTIZA Store.

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