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XELODA
Breast cancer
Colorectal and other GI cancers
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Drug Name:

XELODA Rx

Generic Name and Formulations:
Capecitabine (prodrug of 5-fluorouracil) 150mg, 500mg; tabs.

Company:
Genentech, Inc.

Therapeutic Use:

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:

See full labeling. Give cyclically (2 weeks on, 1 week off). Swallow whole. 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 full labeling); 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 (eg, 950mg/m2 twice daily).

Children:

<18yrs: not established.

Contraindications:

Severe renal impairment (CrCl <30mL/min).

Warnings/Precautions:

Hepatic or renal impairment. Monitor and correct dehydration at initiation. Coronary artery disease. Interrupt therapy if Grade 2/3 hand-and-foot syndrome, Grade 2/3 or 4 diarrhea occurs (give antidiarrheals) until resolves or reduces to Grade 1. Permanently discontinue if severe mucocutaneous reactions (eg, SJS, TEN) occur. Dihydropyrimidine dehydrogenase deficiency. Elderly. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Females of reproductive potential should use effective contraception (during therapy and for 6 months) and males with female partners (during and for 3 months) after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose.

Interactions:

Increased anticoagulant effect with warfarin; monitor PT/INR frequently. Potentiated by leucovorin. Monitor phenytoin and other CYP2C9 substrates.

Pharmacological Class:

Fluoropyrimidine.

Adverse Reactions:

Diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, hyperbilirubinemia; lymphopenia, necrotizing enterocolitis, stomatitis, dermatitis, anorexia, cardiotoxicity, blood dyscrasias, paresthesias, eye irritation, edema, myalgia, dehydration, alopecia.

Note:

Testing considerations: TS (thymidylate synthase), MSI (microsatellite instability), DPD (dihydropyrimidine dehydrogenase)

How Supplied:

Tabs 150mg—60; 500mg—120

Indications for XELODA:

First-line treatment of metastatic colorectal carcinoma when fluoropyrimidine therapy alone is preferred. Adjuvant treatment of Dukes' C colon cancer after complete resection of the primary tumor when fluoropyrimidine therapy alone is preferred.

Adult:

See full labeling. Give cyclically (2 weeks on, 1 week off). Swallow whole. Take with water within 30 minutes after AM & PM meals. ≥18yrs: 1250mg/m2 twice daily. Continue for a total of 8 cycles. Interrupt, adjust dose, and/or treat symptoms if toxicity occurs (eg, hyperbilirubinemia, diarrhea, nausea, vomiting, hand-and-foot syndrome, stomatitis) (see full labeling); 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 (eg, 950mg/m2 twice daily).

Children:

<18yrs: not established.

Contraindications:

Severe renal impairment (CrCl <30mL/min).

Warnings/Precautions:

Hepatic or renal impairment. Monitor and correct dehydration at initiation. Coronary artery disease. Interrupt therapy if Grade 2/3 hand-and-foot syndrome, Grade 2/3 or 4 diarrhea occurs (give antidiarrheals) until resolves or reduces to Grade 1. Permanently discontinue if severe mucocutaneous reactions (eg, SJS, TEN) occur. Dihydropyrimidine dehydrogenase deficiency. Elderly. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Females of reproductive potential should use effective contraception (during therapy and for 6 months) and males with female partners (during and for 3 months) after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose.

Interactions:

Increased anticoagulant effect with warfarin; monitor PT/INR frequently. Potentiated by leucovorin. Monitor phenytoin and other CYP2C9 substrates.

Pharmacological Class:

Fluoropyrimidine.

Adverse Reactions:

Diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, hyperbilirubinemia; lymphopenia, necrotizing enterocolitis, stomatitis, dermatitis, anorexia, cardiotoxicity, blood dyscrasias, paresthesias, eye irritation, edema, myalgia, dehydration, alopecia.

Note:

Testing considerations: TS (thymidylate synthase), MSI (microsatellite instability), DPD (dihydropyrimidine dehydrogenase)

How Supplied:

Tabs 150mg—60; 500mg—120

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