Avoid concomitant use; allopurinol may decrease concentration of capecitabine's active metabolites, reducing efficacy.
Source: NLP:allopurinol
Brand names: Capecitabine
Nucleoside Metabolic Inhibitor · Nucleic Acid Synthesis Inhibitors
Route: Oral
FDA Black Box Warning
WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS Increased risk of serious adverse reactions or death in patients with complete DPD deficiency Test patients for genetic variants of DPYD prior to initiating capecitabine tablets unless immediate treatment is necessary. Avoid use of capecitabine tablets in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency [see Warnings and Precautions ( 5.1 )]. Increased risk of bleeding with concomitant use of Vitamin K antagonists Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking c apecitabine tablets concomitantly with oral vitamin K antagonists, such as warfarin [see Warnings and Precautions ( 5.2 ) , Drug Interactions (7.2 ) ] . Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time capecitabine tablets was introduced. These events occurred in patients with and without liver metastases. Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see Drug Interactions (7.2) ] . WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS See full prescribing information for complete boxed warning. Serious adverse reactions or death may occur in patients with complete DPD deficiency. Test patients for genetic variants of DPYD prior to initiating capecitabine tablets unless immediate treatment is necessary. Avoid use of capecitabine tablets in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. ( 5.1 ) Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine table
Contraindications
4 CONTRAINDICATIONS Capecitabine tablets are contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see Adverse Reactions ( 6.1 )]. History of severe hypersensitivity reactions to fluorouracil or capecitabine (4)
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Based on findings in animal reproduction studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )], capecitabine tablets can cause fetal harm when administered to a pregnant woman. Available human data with capecitabine tablets use in pregnant women is not sufficient to inform the drug-associated risk. In animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryolethality and teratogenicity in mice and embryolethality in monkeys at 0.2 and 0.6 times the exposure (AUC) in patients receiving the recommended dose of 1,250 mg/m 2 twice daily, respectively (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Oral administration of capecitabine to pregnant mice during the period of organogenesis at a dose of 198 mg/kg/day caused malformations and embryo lethality. In separate pharmacokinetic studies, this dose in mice produced 5’-DFUR AUC values that were approximately 0.2 times the AUC values in patients administered the recommended daily dose. Malformations in mice included cleft palate, anophthalmia, microphthalmia, oligodactyly, polydactyly, syndactyly, kinky tail and dilation of cerebral ventricles. Oral administration of capecitabine to pregnant monkeys during the period of organogenesis at a dose of 90 mg/kg/day, caused fetal lethality. This dose produced 5’-DFUR AUC values that were approximately 0.6 times the AUC values in patients administered the recommended daily dose.
9 interactions on record
Avoid concomitant use; allopurinol may decrease concentration of capecitabine's active metabolites, reducing efficacy.
Source: NLP:allopurinol
Concentration of fluorouracil is increased and toxicity may be enhanced. Deaths from severe enterocolitis, diarrhea, and dehydration reported in elderly patients.
Source: NLP:capecitabine
Altered coagulation parameters and bleeding reported with coumarin-derivative anticoagulants. Monitor anticoagulant response frequently.
Source: NLP:capecitabine
Capecitabine may increase phenytoin exposure, increasing risk of adverse reactions. Closely monitor phenytoin levels and adjust dose as appropriate.
Source: NLP:capecitabine
Capecitabine increases exposure of vitamin K antagonists, which may alter coagulation parameters and/or bleeding, potentially resulting in death. Events may occur within days or up to 1 month after discontinuation.
Source: NLP:capecitabine
CYP2C9 inhibitor that increases warfarin effect and INR; requires close INR monitoring
Source: NLP:warfarin
CYP2C9 inhibitor that increases warfarin effect and INR; requires closer INR monitoring.
Source: NLP:warfarin sodium
May increase phenytoin serum levels; monitoring of phenytoin levels recommended.
Source: NLP:fosphenytoin sodium
May increase phenytoin serum levels; monitoring of phenytoin levels recommended.
Source: NLP:extended phenytoin sodium