Brand and Other Names:Xeloda
- Classes: Antineoplastics, Antimetabolite
Dosing & Uses
Dosage Forms & Strengths
Duke Stage C Colon Cancer
Metastatic, resistant to paclitaxel, anthracyclines
Combo therapy with Docetaxel: 1250 m² PO BID for 2 weeks q3Weeks plus docetaxel 75 mg/m² 1 hour IV infusion q3Weeks
Swallow with water within 30 min after a meal
Dosage may need to be individualized to optimize patient management
- CrCl 30-50 mL/min: Reduce dose by 25%
- CrCl <30 mL/min: Contraindicated
Safety & efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Varies with carcinoma type
Hand and foot syndrome
Black Box Warnings
Capecitabine may increase the anticoagulant effects of warfarin increasing the INR several days up to several months after initiating capecitabine or within one month after stopping the therapy. Risk factors include >60 years of age and cancer. Monitor closely
Hypersensitivity to capecitabine or fluorouracil (5-FU)
Severe renal impairment (CrCl <30 mL/min)
May result in bleeding, death; monitor anticoagulant response (e.g., INR) and adjust anticoagulant dose accordingly
Diarrhea may be severe; interrupt capecitabine treatment immediately until diarrhea resolves or decreases to grade 1; recommend standard antidiarrheal treatments
Cardiotoxicity is common in patients with a prior history of coronary artery disease
Increased risk of severe or fatal adverse reactions in patients with low or absent dihydropyrimidine dehydrogenase (DPD) activity; withhold or permanently discontinue capecitabine in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity; no capecitabine dose has been proven safe in patients with absent DPD activity
Interrupt capecitabine treatment until dehydration is corrected; potential risk of acute renal failure secondary to dehydration; monitor and correct dehydration
Can cause fetal harm; advise women of the potential risk to the fetus
Severe mucocutaneous reactions, Steven-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), reported; discontinue therapy in patients who experience a severe mucocutaneous reaction during treatment; capecitabine may induce hand-and-foot syndrome; interrupt capecitabine treatment until hand-and-foot syndrome event resolves or decreases in intensity
If hypervilirubinemia occurs, interrupt therapy immediately until it resolves or decreases in intensity
Do not treat patients with neutrophil counts <1.5 x 10^9;/L or thrombocyte counts <100 x 10^9;/L; if grade 3-4 neutropenia or thrombocytopenia occurs, stop therapy until condition resolves
Pregnancy & Lactation
Pregnancy Category: D
Lactation: excretion in milk unknown/not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Half-life: 0.75 hr
Peak Plasma Time: 1.5 hr
Protein Bound: <60%
Excretion: urine (95%)
Dihydropyrimidine dehydrogenase (DPD), an enzyme encoded by the DPYD gene, is the rate-limiting step in pyrimidine catabolism and deactivates >80% of 5FU standard doses and the 5FU prodrug capecitabine
Contraindicated in patients with DPD deficiency; causes severe toxicity with conventional doses (ie, grade III/IV toxicity and potentially fatal neutropenia, mucositis, and diarrhea)
Because true DPD deficiency is rare and because the clinical implications of partial deficiency are still unclear, screening for mutations prior to initiating therapy is not warranted
Genetic testing laboratories
- The following companies currently offer testing for DPYD*2A mutations
- EntroGen (http://www.entrogen.com)
- Myriad (http://www.myriadtests.com)
- LabCorp (http://www.labcorp.com)
- Molecular Diagnostics Laboratories (http://www.mdl-labs.com)
Mechanism of Action
Converted to 5-FU by thymidine phosphorylase in neoplastic tissue
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