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capecitabine (Rx)Brand and Other Names:Xeloda

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 150mg
  • 500mg
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Duke Stage C Colon Cancer

Adjuvant therapy

1,250 mg/m² PO BID x 2 weeks, followed by 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)  

Colorectal Cancer

Metastatic disease

1250 mg/m² BID for 2 weeks q21 days 

Breast Cancer

Metastatic, resistant to paclitaxel, anthracyclines

Monotherapy: 1250 mg/m² BID for 2 weeks q3Weeks 

Combo therapy with Docetaxel: 1250 m² PO BID for 2 weeks q3Weeks plus docetaxel 75 mg/m² 1 hour IV infusion q3Weeks

Administration

Swallow with water within 30 min after a meal

Dosage may need to be individualized to optimize patient management

Dose Modifications

Renal impairment

  • CrCl 30-50 mL/min: Reduce dose by 25%
  • CrCl <30 mL/min: Contraindicated

Safety & efficacy not established

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Interactions

Interaction Checker

capecitabine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Varies with carcinoma type

            10%

            Diarrhea

            Nausea

            Anemia

            Lymphopenia

            Hand and foot syndrome

            Edema

            Fatigue

            Fever

            Headache

            Pain

            Paresthesia

            Alopecia

            Dermatitis

            Abdominal pain

            Anorexia

            Appetite decreased

            Constipation

            Dyspepsia

            Stomatitis

            Vomiting

            Neutropenia

            Thrombocytopenia

            Dyspnea

            Bilirubin increased

            Eye irritation

            1-10%

            Chest pain

            Dermatitis

            Pruritus

            Rash

            Dizziness

            Headache

            Weakness

            Dehydration

            Dry mouth

            Dyspepsia

            Taste disturbance

            Back pain

            Postmarketing reports

            Toxic leukoencephalopathy

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            Warnings

            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

            Contraindications

            Hypersensitivity to capecitabine or fluorouracil (5-FU)

            Severe renal impairment (CrCl <30 mL/min)

            Cautions

            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

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excretion in milk unknown/not recommended

            Pregnancy Categories

            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.

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            Pharmacology

            Half-life: 0.75 hr

            Peak Plasma Time: 1.5 hr

            Protein Bound: <60%

            Metabolism: hepatic

            Metabolites: 5'-DFUR

            Excretion: urine (95%)

            Dialyzable: yes

            Pharmacogenomics

            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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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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