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Capecitabine Prescribing Information
WARNING: CAPECITABINE-WARFARIN INTERACTION
Capecitabine Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important capecitabine-Warfarin drug interaction was demonstrated in a clinical pharmacology trial
[see Warnings and Precautions (5.2) and Drug Interactions (7.1)]
. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine 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 capecitabine was introduced. These events occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. 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. Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
- Adjuvant Colon Cancer(1.1)
– Patients with Dukes’ C colon cancer
- Metastatic Colorectal Cancer(1.1)
– First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
- Metastatic Breast Cancer(1.2)
– In combination with docetaxel after failure of prior anthracycline containing therapy
– As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen
- Take capecitabine tablets with water within 30 min after a meal (2.1)
- Monotherapy: 1250 mg/m
2 twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles (2.2) - Adjuvant treatment is recommended for a total of 6 months (8 cycles) (2.2)
- In combination with docetaxel, the recommended dose of capecitabine tablets is 1250 mg/m
2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m
2 as a 1-hour IV infusion every 3 weeks (2.2) - Capecitabine tablets dosage may need to be individualized to optimize patient management (2.3)
- Reduce the dose of capecitabine tablets by 25% in patients with moderate renal impairment (2.4)
Capecitabine tablets USP are supplied in strengths of 150 mg and 500 mg for oral administration.
150 mg
: Light pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 150.500 mg
: Dark pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 500.- Lactation:Advise women not to breast feed. (8.2)
- Females and Males of Reproductive Potential:Verify pregnancy status of females prior to initiation of Capecitabine tablets. Advise males with female partners of reproductive potential to use effective contraception. (8.3)
- Geriatric: Greater incidence of adverse reactions. Monitoring required. (8.5)
- Hepatic Impairment: Monitoring is recommended in patients with mild to moderate hepatic impairment. (8.6)
- Renal Impairment: Reduce capecitabine starting dose in patients with moderate renal impairment (2.4, 8.7, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 01/2020
- Severe Renal Impairment (4.1)
- Hypersensitivity (4.2)
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available