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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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New drug OK'd for hard-to-treat breast cancer - FDA approves Xeloda, manufactured by Hoffmann-La Roche Inc - Brief Article
From FDA Consumer, 7/1/98

Women with hard-to-treat breast cancer now have another option for managing their potentially life-threatening disease.

The oral treatment Xeloda (capecitabine) was approved April 30 for patients with advanced breast cancer for which no acceptable alternative treatments are available. Specifically, the drug is for patients whose tumors are resistant to Taxol (paclitaxel) with an anthracycline or for those who should not have anthracycline therapy.

Xeloda was granted accelerated approval, an early approval process applied to some drugs that are used to treat life-threatening conditions. In studies, the drug measurably shrank some patients' tumors. The most common side effects of Xeloda include diarrhea, nausea, vomiting, fatigue, painful inflammation of the mouth, and painful rash and swelling of the hands and feet.

As a condition of approval, FDA is requiring the manufacturer, Hoffmann-La Roche Inc., Newark, N.J., to conduct further studies of the drug's clinical benefits.

COPYRIGHT 1998 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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