Names and pronunciation
(cap-eh-sit′ah-bean) Xeloda
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Drug reference
(cap-eh-sit′ah-bean) Xeloda
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Func. class.: Antineoplastic, antime- tabolite
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Chem. class.: Pyrimidine carbamate
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Do not confuse: Xeloda/Xenical
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ACTION: Competes with physiologic substrate of DNA synthesis, thereby inter- fering with cell replication in the S phase of cell cycle (before mitosis); also inter- feres with RNA and protein synthesis; product is converted to 5-FU
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USES: PACLitaxel- and anthracy- cline-resistant metastatic breast, colorectal cancer when 5-FU monotherapy is preferred; treatment of colorectal cancer patients who have undergone complete resection of their primary tumors C
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Unlabeled uses: Breast cancer (HER-2 negative) (adjuvant), pancreatic cancer (adjuvant locally advanced)
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CONTRAINDICATIONS: Preg- nancy, hypersensitivity to 5-FU, infants, severe renal impairment (CCr <30 mL/ min) Precautions: Breastfeeding, children, infections, radiation therapy, anticoag- ulation, geriatric patients, renal/ hepatic/cardiac disease, DPD deficiency
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Black Box Warning: Anticoagulant ther- apy Black Box Warning: Increase: bleeding risk—anticoagulants, NSAIDs, salicy- lates, platelet inhibitors, thrombolytics; monitor PT and INR Decrease: capecitabine effect—allopuri- nol; avoid using together Drug/Food Increase: absorption; give within 30 min of a meal Drug/Lab Test Increase: bilirubin Decrease: HB/Hct/RBC, neutrophils, platelets, WBC Black Box Warning: Bleeding: hematuria, heme-positive stools, bruising or petechiae of mucosa or orifices q8hr; monitor INR and PT in those taking coumarin-derivative anticoagulants; adjustment of dose may be needed , those >60 at higher risk of bleed- ing; dose may need to be decreased • Dyspnea, crackles, unproductive cough, chest pain, tachypnea, fatigue, increased pulse, pallor, lethargy; person- ality changes with high doses • Hand and foot syndrome/Stevens- Johnson syndrome: paresthesia, tin- gling, painful/painless swelling, blistering, erythema with severe pain of hands or feet, toxicity is divided into grade 1, 2, 3; if grade 2 or 3, product should be discon- tinued until grade 1 • GI toxicity: severe diarrhea (multiple times/day or at night), nausea, vomiting, stomatitis, fever; adjust dose, stop treat- ment if severe • Buccal cavity q8hr for dryness, sores, ulceration, white patches, oral pain, bleeding, dysphagia • Fluid, electrolytes may need to be given; elderly patients are at greater risk of GI symptoms, dehydration • Rinsing of mouth tid-qid with water, club soda; brushing of teeth bid-tid with soft brush or cotton-tipped applicators for stomatitis; use unwaxed dental floss
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SIDE EFFECTS CNS: Dizziness, headache, paresthesia, fatigue, insomnia CV: Venous thrombosis, edema, chest pain GI: Nausea, vomiting, anorexia, diar- rhea, stomatitis, abdominal pain, consti- pation, dyspepsia, hyperbilirubinemia, hepatitis HEMA: Neutropenia, lymphopenia, thrombocytopenia, anemia INTEG: Dermatitis, nail disorders, alo- pecia, rash OTHER: Eye irritation, edema, limb pain, pyrexia, dehydration, renal impair- ment, Stevens-Johnson syndrome RESP: Cough, dyspnea, pulmonary embolism
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INTERACTIONS Increase: toxicity—leucovorin fosphe- nytoin; monitor for toxicity Increase: capecitabine levels—antacids (aluminum, magnesium) Increase: phenytoin level—phenytoin; monitor phenytoin level
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DOSAGE AND ROUTES Breast cancer alone or with DOCEtaxel; metastatic colorectal cancer when fluoropyrimidine alone is preferred; Dukes Stage C colon cancer after resection when fluoro- pyrimidine alone is preferred Adult: PO 2500 mg/m2/day divided q12hr after a meal × 2 wk, repeat q3wk; Dukes C colon cancer 8 cycles (24 wk), max 5600 mg/day Renal dose • Adult: PO CCr 30-50 mL/min, decrease initial dose to 75% of usual dose; CCr <30 mL/min, contraindicated Primary breast cancer (adjuvant therapy) in those with HER-2 neg- ative who have residual invasive disease containing an anthracycline or/and taxane (unlabeled) • Adult: PO 1250 mg/m2 bid on days 1 to 14 of a 21-day cycle × 6-8 cycles Pancreatic adenocarcinoma (adju- vant) after rescetion (unlabeled) • Adult: PO 1660 mg/m2 divided bid on day 1-21 q28 days with gem- citabine × 6 cycles 8-12 wk after re- section Pancreatic cancer (locally advanced or metastatic)(unlabeled) Adult: PO 1250 mg/m2 bid on days 1-14 of a 3-wk cycle or 830 mg/m2 bid with gemcitabine on days 1-21 of a 4-wk cycle
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Available forms: Tablets 150, 500 mg
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Administer: • Swallow whole, take with water within 30 min of a meal • Use cytotoxic handling procedures
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Assess: • Bone marrow suppression, CBC (RBC, Hct, HB), differential, platelet count weekly; withhold product if WBC is <1000/mm3, platelet count is <50,000/ mm3, or RBC, Hct, HB low; notify prescriber of these results; frequently monitor INR in those receiving warfarin concurrently • Renal studies: BUN, serum uric acid, urine CCr, electrolytes before, during therapy • Infection: monitor temperature q4hr; fever may indicate beginning infection; no rectal temperatures • Hepatic studies prior to, during ther- apy: bilirubin, ALT, AST, alkaline phopha- tase as needed or monthly
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Evaluate: • Therapeutic response: decreased tu- mor size, spread of malignancy
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To avoid foods with citric acid, hot tem- perature, or rough texture if stomatitis is present; to take with water within 30 min of end of meal; not to take if dose is missed • How to take (on for 14 days then 7 days off, then start a new cycle); do not crush, cut • Not to double dose if dose is missed • To immediately report severe diarrhea, vomiting, stomatitis, fever of more than 100°F (37.8°C), hand and foot syndrome, anorexia; stop taking product • To report bleeding in those taking anti- coagulants • To report signs of infection: in- creased temperature, sore throat, flulike symptoms, to avoid crowds, persons with known infections; signs of anemia: fa- tigue, headache, faintness, shortness of breath, irritability; bleeding; to avoid use of razors, commercial mouthwash • To use OTC antidiarrheals for mild diarrhea (4-6 stools/day or diarrhea at night) • Pregnancy/breastfeeding: to notify prescriber if pregnancy is planned or suspected; to avoid pregnancy while taking this product, use adequate con- traception during and for 6 mo after last dose; males should use contraception during and for 3 mo after last dose if partner is of child bearing potential; not to breastfeed • That continuing exams and blood work will be needed
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PHARMACOKINETICS Readily absorbed, peak 1½ hr, food decreases absorption, extensively metab- olized in the liver, elimination half-life 45 min
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• Adult: PO CCr 30-50 mL/min, decrease initial dose to 75% of usual dose; CCr <30 mL/min, contraindicated Primary breast cancer (adjuvant therapy) in those with HER-2 neg- ative who have residual invasive disease containing an anthracycline or/and taxane (unlabeled)
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• Adult: PO 1250 mg/m2 bid on days 1 to 14 of a 21-day cycle × 6-8 cycles Pancreatic adenocarcinoma (adju- vant) after rescetion (unlabeled)
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• Adult: PO 1660 mg/m2 divided bid on day 1-21 q28 days with gem- citabine × 6 cycles 8-12 wk after re- section Pancreatic cancer (locally advanced or metastatic)(unlabeled) Adult: PO 1250 mg/m2 bid on days 1-14 of a 3-wk cycle or 830 mg/m2 bid with gemcitabine on days 1-21 of a 4-wk cycle
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