Celabin Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Capecitabine

Indications/Uses

Adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. 1st-line treatment of metastatic colorectal cancer. Treatment of metastatic colorectal cancer following irinotecan-containing combination therapy w/ oxaliplatin. Treatment of locally advanced or metastatic breast cancer after failure of anthracycline-containing chemotherapy w/ docetaxel. Monotherapy w/ locally advanced or metastatic breast cancer resistant to both paclitaxel & anthracycline-containing chemotherapy regimen or paclitaxel resistant & for whom anthracycline therapy is not indicated.

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Dosage/Direction for Use

Monotherapy in metastatic colorectal, adjuvant colorectal or metastatic breast cancer 1,250 mg/m² bid (morning & evening) for 2 wk, followed by 1 wk rest period for a total of 8 cycles. Combination therapy for metastatic colorectal w/ oxaliplatin 1,000 mg/m² bid for 2 wk followed by 1 wk rest period + oxaliplatin 130 mg/m² as 2 hr IV infusion every 3 wk. The 1st dose is given on the evening of day 1 & the last dose on the morning of day 15. Combination therapy for metastatic breast cancer w/ docetaxel 1,250 mg/m² bid for 2 wk followed by a 1 wk rest period + docetaxel 75 mg/m² as 1 hr IV infusion on the 1st day of each 3-wk cycle.

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Overdosage

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Administration

Should be taken with food: Take w/in 30 min after meals.

Contraindications

Hypersensitivity. History of severe & unexpected reactions to fluoropyrimidine therapy. Dihydropyrimidine dehydrogenase (DPD) deficiency; severe leukopenia, neutropenia or thrombocytopenia; severe hepatic & renal (CrCl <30 mL/min) impairment. Sorivudine & brivudine. Pregnancy & lactation.

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Special Precautions

Altered coagulation parameters &/or bleeding, including death w/ warfarin & phenprocoumon. Carefully monitor patients w/ severe diarrhea; necrotizing enterocolitis. Dehydration. Stevens-Johnson syndrome & toxic epidermal necrolysis; palmar-plantar erythrodysesthesia. Cardiotoxicity. Dihydropyrimidine dehydrogenase deficiency. Hyperbilirubinemia. Should not be given to patients w/ baseline neutrophil counts of <1.5 x 10⁹/L &/or thrombocyte counts of <100 x 10⁹/L. Discontinue if patient is experiencing ≥grade 2 nausea or vomiting. Pre-existing hypo- or hypercalcemia; CNS/peripheral nervous system disease eg, brain metastasis or neuropathy; DM or electrolyte disturbances. Corneal disorders & keratitis. Hepatic & renal impairment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Childn <18 yr. Elderly ≥80 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, nausea, vomiting, abdominal pain, stomatitis, hand-&-foot syndrome, fatigue, asthenia, anorexia, cardiotoxicity, increased renal dysfunction, thrombosis or embolism.

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Drug Interactions

Altered coagulation parameters &/or bleeding w/ warfarin & phenprocoumon. Increased phenytoin levels. Enhanced toxicity w/ folinic acid; leucovorin; sorivudine & analogues, interferon α. Increase in plasma conc w/ Al & Mg hydroxide-containing antacids. Decreased efficacy w/ allopurinol. Decreased absorption rate w/ food.

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Caution For Usage

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Storage

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Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Celabin FC tab 500 mg

Packing/Price

60's

Celabin

capecitabine

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc