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Xeloda

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Xeloda

XELODA®
(capecitabine) Tablets

Xeloda

WARNING

XELODA-WARFARIN INTERACTION

XELODA Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarinderivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important XELODA-Warfarin drug interaction was demonstrated in a clinical pharmacology trial [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time XELODA was introduced. These events occurred within several days and up to several months after initiating XELODA therapy and, in a few cases, within 1 month after stopping XELODA. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

DRUG DESCRIPTION

XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5- fluorouracil.

The chemical name for capecitabine is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula:

XELODA® (capecitabine) Structural Formula Illustration

Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C.

XELODA is supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.

What are the possible side effects of capecitabine (Xeloda)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe diarrhea (more than 4 times per day, or during the night);
  • vomiting (more than once in 24 hours);
  • nausea, loss of appetite, eating much less than usual;
  • weakness, feeling light-headed, hot or dry skin;
  • pain, tenderness, redness, swelling, blistering, or peeling skin on your hands or feet;
  • fever,...

Read All Potential Side Effects and See Pictures of Xeloda »

What are the precautions when taking capecitabine (Xeloda)?

Before taking capecitabine, tell your doctor or pharmacist if you are allergic to it; or to 5-fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, a certain enzyme deficiency (dihydropyrimidine dehydrogenase deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow suppression), heart problems (e.g., coronary artery disease, heart failure), kidney problems, liver...

Read All Potential Precautions of Xeloda »

Last reviewed on RxList: 12/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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Xeloda - User Reviews

Xeloda User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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