Generic Name and Formulations:
Capecitabine (prodrug of 5-fluorouracil) 150mg, 500mg; tabs.
Company:
Roche Laboratories
Indications for XELODA:
Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel when further anthracycline therapy is not indicated (eg, prior cumulative doses of 400mg/m2 of doxorubicin or its equivalents). With docetaxel for metastatic breast cancer after failure of prior anthracycline-containing regimen.
Adult Dose for XELODA:
See literature. Give cyclically (2 weeks on, 1 week off). Take with water within 30 minutes after AM & PM meals. ≥18yrs: 1250mg/m2 twice daily. Combination therapy: give with docetaxel 75mg/m2 IV infused over 1 hour every 3 weeks. Interrupt, adjust dose, and/or treat symptoms if toxicity occurs (eg, hyperbilirubinemia, diarrhea, nausea, vomiting, hand-and-foot syndrome, stomatitis) (see literature); do not increase dose afterwards. Renal impairment (CrCl 51–80mL/min): monitor carefully; (CrCl 30–50mL/min): reduce capecitabine dose to 75% of starting dose (ie, 950mg/m2 twice daily).
Children's Dose for XELODA:
<18yrs: not recommended.
Pharmacological Class:
Fluoropyrimidine.
Contraindications:
Severe renal impairment (CrCl <30mL/min). Dihydropyrimidine dehydrogenase deficiency. Pregnancy (Cat.D), nursing mothers: not recommended.
Warnings/Precautions:
Hepatic or renal dysfunction. Coronary artery disease. Elderly (≥80years).
Interactions:
Potentiated by leucovorin. Monitor warfarin, other CYP2C9 substrates, phenytoin.
Adverse Reactions:
Diarrhea, lymphopenia, necrotizing enterocolitis, hand-and-foot syndrome, GI upset, stomatitis, fatigue, dermatitis, anorexia, cardiotoxicity, bone marrow suppression, blood dyscrasias, hyperbilirubinemia, paresthesias, eye irritation, fever, headache, edema, dizziness, insomnia, myalgia, dehydration, nail disorder, limb pain, skin discoloration, alopecia.
Note:
Testing considerations: TS (thymidylate synthase), MSI (microsatellite instability), DPD (dihydropyrimidine dehydrogenase)
How Supplied:
Tabs 150mg—60
500mg—120