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Xeloda

Capecitabine (brand name: Xeloda®) is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. It is enzymatically converted to fluorouracil in the body, where it inhibits DNA synthesis and slows growth of tumor tissue. more...

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Indications

Capecitabine is FDA-approved for:

Metastatic Colorectal Cancer

  • Used as first-line monotherapy, if appropriate.

Metastatic Breast Cancer

  • Used in combination with docetaxel, after failure of anthracycline-based treatment.
  • Used as monotherapy, if the patient has failed paclitaxel-based treatment, and if anthracycline-based treatment has either failed or cannot be continued for other reasons (i.e., the patient has already received the maximum lifetime dose of an anthracycline).

Dose

The usual starting dose is 2,500 mg/m2/day in two divided doses, 12 hours apart. One cycle includes two weeks of treatment followed by one week without treatment. Cycles can be repeated every three weeks.

Dose Adjustments

  • For mild renal dysfunction (creatinine clearance 30-50 mL/min), it is recommended to reduce dose by 25%.
  • For severe renal dysfunction (creatinine clearance <30 mL/min), treatment is not recommended.
  • There is no recommendation for hepatic dysfunction.
  • For elderly patients, lower doses may be required due to higher incidences of serious adverse reactions.

Administration

Take orally with water, within 30 minutes after a meal.

Potential Adverse Reactions (Major)

  • Cardiovascular: EKG changes, myocardial infarction, angina (these may be more common in patients with pre-existing coronary artery disease)
  • Dermatological: Hand-foot syndrome (numbness, tingling, pain, redness, or blistering of the palms of the hands and soles of the feet)
  • Gastrointestinal: Diarrhea (sometimes severe), nausea, stomatitis
  • Hematological: Neutropenia, anemia, thrombocytopenia
  • Hepatic: Hyperbilirubinemia

Drug Interactions

  • Capecitabine may interact with warfarin and increase bleeding risk. It is recommended to watch coagulation levels (INR) closely and adjust warfarin doses appropriately.
  • Capecitabine may inhibit cytochrome CYP2C9 enzyme, and therefore increase levels of substrates such as phenytoin. It is recommended to monitor phenytoin levels in patients taking both medications. Other substrates of CYP2C9 may also be affected. Evaluate according to clinical judgment.
  • Much as fluorouracil, the concomitant use of leucovorin may increase both the efficacy and the toxicity of capecitabine.

Pregnancy / Lactation Information

  • Capecitabine is pregnancy category D. Women of childbearing potential are advised to avoid becoming pregnant while using capecitabine.
  • Significant amounts of capecitabine may be excreted into the breast milk. It is recommended to discontinue nursing while using capecitabine.

Read more at Wikipedia.org


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Drug combination approved for advanced breast cancer - Updates - Xeloda and Taxotere - Brief Article
From FDA Consumer, 1/1/02

Two drugs already on the market to treat breast cancer have been approved by the FDA to be used in combination for an even greater effect in treating advanced cases of the disease.

Xeloda (capecitabine), an oral cancer therapy, and Taxotere (docetaxel), an intravenous drug, can now be used together to treat advanced cancer that has progressed after being treated with an anthracycline-containing therapy, such as Adriamycin (doxorubicin). Doctors limit anthracycline-containing treatments to life-threatening situations.

The FDA approved the drug combination in September after a study of 511 cancer patients demonstrated improvements in overall response rates, lengths of time before the disease worsened, and survival rates.

Xeloda and Taxotere individually are associated with side effects such as gastrointestinal symptoms, nausea, vomiting, and painful inflammation of the mouth. People with breast cancer also should be aware of these side effects when taking the newly approved drug combination. If side effects occur, it may be necessary to reduce the dose, or to interrupt or discontinue treatment.

In addition, Xeloda has a significant drug interaction with oral coumarin-derivative anticoagulant therapy, which can cause serious bleeding complications. The FDA urges people receiving Xeloda and a coumarin-derivative, such as Coumadin, to have their anticoagulant response monitored frequently. The agency also says that dosages of the drugs may have to be modified for people who have impaired kidney function.

Xeloda is manufactured by Roche Laboratories Inc., Nutley, N.J. Taxotere is marketed by Aventis Pharmaceuticals Inc., Bridgewater, N.J.

COPYRIGHT 2002 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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