文档介绍：1
2 XELODA®
3 (capecitabine)
4 TABLETS
5 Rx only
6 WARNING
7 XELODA Warfarin Interaction: Patients receiving concomitant capecitabine and oral
8 coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR
9 or prothrombin time) monitored frequently in order to adjust the anticoagulant dose
10 accordingly. A clinically important XELODA-Warfarin drug interaction was
11 demonstrated in a clinical pharmacology trial (see CLINICAL PHARMACOLOGY
12 and PRECAUTIONS). Altered coagulation parameters and/or bleeding, including death,
13 have been reported in patients taking XELODA concomitantly with coumarin-derivative
14 anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown
15 clinically significant increases in prothrombin time (PT) and INR in patients who were
16 stabilized on anticoagulants at the time XELODA was introduced. These events occurred
17 within several days and up to several months after initiating XELODA therapy and, in a
18 few cases, within 1 month after stopping XELODA. These events occurred in patients
19 with and without liver metastases. Age greater than 60 and a diagnosis of cancer
20 independently predispose patients to an increased risk of coagulopathy.
21 DESCRIPTION
22 XELODA (capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It
23 is an orally administered systemic prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which
24 is converted to 5-fluorouracil.
25 The chemical name for capecitabine is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-
26 cytidine and has a molecular weight of . Capecitabine has the following structural
27 formula:
ONN HO
O