TM Owner H2-Pharma (US); Cheplapharm (EU)
Xeloda IV 500mg FC Tablet
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Indications & Clinical Uses
- There is no intravenous form of Xeloda, and 'Xeloda IV' is not an approved brand name.
- The information here comes from the Xeloda label for capecitabine 500 mg film-coated tablets, which are taken by mouth only.
- Capecitabine is an oral fluoropyrimidine chemotherapy that the body converts to fluorouracil; treatment is started and supervised by a cancer specialist.
- In the United States the label covers adjuvant Stage III colon cancer, perioperative rectal cancer, unresectable or metastatic colorectal cancer, advanced or metastatic breast cancer (alone or with docetaxel), gastric, oesophageal and gastro-oesophageal junction cancer, and adjuvant pancreatic cancer.
- The EU information covers colon, colorectal, gastric and breast cancers.
- Only the 150 mg and 500 mg tablet strengths exist, so never expect a vial or infusion.
Side Effects
- Depending on the cancer and regimen, reactions affecting 30% or more of people in the US label include hand-foot syndrome (redness, swelling, peeling or pain of the palms and soles), diarrhoea and nausea; anaemia, vomiting, mouth sores, stomach pain and tiredness are also common.
- The US label carries a boxed warning: serious adverse reactions or death in people with complete dihydropyrimidine dehydrogenase (DPD) deficiency, and bleeding, including death, when taken with vitamin K antagonists such as warfarin.
- Report urgently: severe or persistent diarrhoea (treatment must be interrupted), dehydration, chest pain or palpitations, severe blistering skin or mouth reactions, yellowing of the skin or eyes, fever or infection, and unusual bleeding.
Precautions & Warnings
- DPD deficiency testing is required before the first dose unless treatment cannot wait; people with complete DPD deficiency must not take capecitabine.
- The US label lists only severe hypersensitivity to fluorouracil or capecitabine as a contraindication, while the EU label also contraindicates brivudine within 4 weeks, severe renal impairment (creatinine clearance below 30 mL/min), severe liver impairment, severe blood-count deficiencies, pregnancy and breastfeeding.
- Warnings include diarrhoea, dehydration, cardiotoxicity, kidney toxicity, serious skin reactions, bone marrow suppression and raised bilirubin, so regular blood tests and INR checks are needed.
- Females of reproductive potential need effective contraception during treatment and for 6 months after the last dose; males with female partners for 3 months.
- Swallow tablets with water within 30 minutes after a meal; do not use them as an injection or infusion.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you use.
- Increase effect or toxicity: warfarin and other vitamin K antagonists (capecitabine raised S-warfarin exposure by 57% and INR by 91%, with bleeding including deaths, so INR must be checked often); phenytoin (levels can rise); CYP2C9 substrate drugs; leucovorin (folinic acid), which increases fluorouracil toxicity; brivudine, not to be used within 4 weeks before capecitabine in the EU; and nephrotoxic drugs.
- Avoid allopurinol.
- Food lowers capecitabine absorption by roughly 34% to 60%, so take tablets within 30 minutes after a meal as directed.
- No specific drugs that reduce its efficacy are listed in the sections reviewed.
References
Frequently Asked Questions
There is no intravenous Xeloda. Xeloda (capecitabine) is an oral chemotherapy tablet used for colorectal, breast, gastric and oesophageal cancer and, in the US, adjuvant pancreatic cancer. If you were told about an injection, check with your cancer specialist which medicine is meant.
Xeloda (capecitabine) is swallowed as a tablet, not injected. Take it whole with water within 30 minutes after a meal, twice daily. The EU label describes 1250 mg/m² twice daily for 14 days then 7 days off, in 21-day cycles; your dose depends on your regimen.
Xeloda (capecitabine) commonly causes hand-foot syndrome, diarrhoea, nausea, vomiting, mouth sores and tiredness. The US boxed warning covers severe toxicity or death in complete DPD deficiency and bleeding with warfarin-type drugs. Call your care team at once for severe diarrhoea, chest pain, severe skin reactions, fever or bleeding.
Avoid warfarin-type blood thinners unless your INR is checked often, because capecitabine can cause serious bleeding, including deaths. Also avoid allopurinol, and in the EU brivudine within 4 weeks. Tell your provider about phenytoin and leucovorin. Do not take Xeloda on an empty stomach.
Yes. Xeloda (capecitabine) needs DPD deficiency testing before the first dose unless treatment cannot wait, as complete DPD deficiency can cause severe or fatal toxicity. During treatment you will have blood counts, kidney and liver checks, and INR monitoring if you take warfarin.
No. Xeloda (capecitabine) can harm an unborn baby, and the EU label contraindicates it in pregnancy and breastfeeding. Females who could become pregnant need effective contraception during treatment and for 6 months after the last dose; males with female partners need it for 3 months.
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