Xeloda: Targeted Oral Chemotherapy for Gastrointestinal and Breast Cancers
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| 50 | $15.86
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Synonyms | |||
Xeloda (capecitabine) is an orally administered prodrug chemotherapeutic agent specifically designed to deliver targeted 5-fluorouracil (5-FU) therapy. It offers a convenient, patient-centric alternative to traditional intravenous fluoropyrimidine regimens, converting to its active form preferentially within tumor tissue. This mechanism allows for higher intratumoral concentrations of the cytotoxic agent while potentially minimizing systemic exposure. It is a cornerstone treatment in specific protocols for colorectal, gastric, and breast cancers, representing a significant advancement in outpatient oncology management.
Features
- Active pharmaceutical ingredient: Capecitabine.
- Pharmaceutical form: Film-coated tablets available in two strengths (150 mg and 500 mg).
- Prodrug activation: Converted to 5-fluorouracil (5-FU) enzymatically through a three-step process, with the final activation step occurring preferentially in tumor tissue by the enzyme thymidine phosphorylase.
- Dosing regimen: Typically administered on a 21-day cycle (2 weeks of treatment followed by 1 week of rest).
- Administration: Oral, with ingestion following a meal within 30 minutes.
Benefits
- Oral Administration: Eliminates the need for intravenous infusions, central lines, or pumps, significantly enhancing patient convenience and quality of life by allowing treatment to be managed at home.
- Tumor-Selective Activation: The unique metabolic pathway aims to deliver higher concentrations of the active chemotherapeutic agent (5-FU) directly to the tumor site, potentially improving efficacy and reducing systemic toxicity compared to bolus IV 5-FU.
- Proven Efficacy in Multiple Indications: Demonstrates high efficacy as both a monotherapy and a component of combination regimens in the adjuvant and metastatic settings for colorectal, gastric, and breast cancers.
- Outpatient Treatment Model: Facilitates a more normalized daily routine for patients, reducing hospital visits and associated burdens, which can lead to better adherence to treatment protocols.
- Flexible Dosing: Allows for dose modifications and interruptions based on individual patient tolerance and the management of adverse events, supporting personalized treatment approaches.
Common use
Xeloda is indicated for the treatment of patients with:
- Adjuvant Colon Cancer: Following complete resection of the primary tumor in patients with Dukes’ C colon cancer, as a single agent.
- Metastatic Colorectal Cancer: As first-line treatment, either as a single agent or in combination with other chemotherapeutic agents like oxaliplatin (XELOX regimen).
- Metastatic Breast Cancer: For patients resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen, or resistant to paclitaxel and for whom further anthracycline therapy is not indicated. It is also used in combination with docetaxel after failure of prior anthracycline-containing chemotherapy.
- Gastric Cancer: As a first-line treatment for advanced gastric cancer in combination with a platinum-based regimen.
Dosage and direction
- The recommended dosage is based on body surface area (BSA). The standard monotherapy dose is 1250 mg/m² administered orally twice daily (morning and evening), equivalent to a total daily dose of 2500 mg/m².
- Doses are typically rounded to the nearest tablet strength (150 mg or 500 mg) to provide a practical dosing schedule.
- Tablets must be swallowed whole with water within 30 minutes after a meal (breakfast and dinner).
- Treatment is usually given for 14 consecutive days followed by a 7-day rest period, constituting one 21-day cycle.
- Dosage requires adjustment in patients with renal impairment. Dose reductions or interruptions are mandatory for management of specific toxicities (e.g., hand-foot syndrome, diarrhea, neutropenia) as per prescribing guidelines and clinical judgement.
Precautions
- Myelosuppression: Xeloda can cause neutropenia, thrombocytopenia, and anemia. Complete blood counts must be monitored regularly throughout treatment.
- Diarrhea: Can be severe and lead to dehydration, electrolyte imbalance, and renal impairment. Severe diarrhea necessitates dose interruption or discontinuation and aggressive supportive care.
- Cardiotoxicity: Rare but serious cardiotoxicities including myocardial infarction, angina, dysrhythmias, and cardiac arrest have been reported. Use with caution in patients with a history of coronary artery disease.
- Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Patients with a complete or partial deficiency in the DPD enzyme are at significantly increased risk of severe, life-threatening toxicity (e.g., neutropenia, neuropathy, diarrhea). Testing for DPD deficiency should be considered.
- Coumarin Derivative Interaction: Concomitant use with warfarin can lead to altered coagulation parameters and/or bleeding. Frequent monitoring of INR is required.
- Pregnancy and Lactation: Xeloda can cause fetal harm. It is contraindicated in pregnancy. Women of childbearing potential should use effective contraception during and for 6 months after treatment. Breastfeeding is not recommended.
Contraindications
Xeloda is contraindicated in patients with:
- Known severe hypersensitivity to capecitabine, 5-fluorouracil, or any component of the formulation.
- Known complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
- Severe renal impairment (creatinine clearance below 30 mL/min as calculated by Cockcroft-Gault).
- Pregnancy.
Possible side effect
Adverse reactions are common and often dose-dependent. The most frequently observed include:
- Gastrointestinal Disorders: Diarrhea (may be severe), nausea, vomiting, stomatitis, abdominal pain, constipation, dyspepsia.
- Dermatological Disorders: Hand-Foot Syndrome (Palmar-Plantar Erythrodysesthesia - PPE) - characterized by numbness, dysesthesia, paresthesia, pain, swelling, erythema, desquamation, and blistering. Rash, dry skin, nail disorders.
- Hematological Disorders: Neutropenia, leukopenia, anemia, thrombocytopenia, lymphopenia.
- General Disorders: Fatigue, asthenia, pyrexia, edema, lethargy.
- Metabolism and Nutrition Disorders: Anorexia, dehydration.
- Nervous System Disorders: Headache, paresthesia, dysgeusia, dizziness, insomnia.
- Other: Hyperbilirubinemia, increased liver enzymes, conjunctivitis, eye irritation.
Drug interaction
- Warfarin and Other Coumarin Derivatives: Xeloda can significantly increase INR and the risk of bleeding. Frequent INR monitoring and warfarin dose adjustment are essential.
- Phenytoin: Concomitant use can increase phenytoin levels, increasing the risk of toxicity. Serum phenytoin levels should be monitored.
- Leucovorin: Concomitant administration may increase the concentration of 5-FU, potentially increasing toxicity (e.g., gastrointestinal and hematological).
- Allopurinol: May decrease the efficacy of Xeloda by interfering with its activation pathway; concurrent use is generally not recommended.
- Antacids: The effect of simultaneous administration has not been studied, but separation of dosing may be prudent.
Missed dose
A missed dose should not be replaced. The next dose should be taken at the usual scheduled time. Patients should be instructed to never take a double dose to make up for a forgotten one, as this significantly increases the risk of severe toxicity.
Overdose
Overdose would be expected to manifest as severe, acute exacerbations of the known adverse effects, particularly severe nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow suppression (neutropenia, thrombocytopenia). There is no known specific antidote for capecitabine overdose. Management consists of immediate discontinuation of the drug and initiation of supportive, symptomatic treatment, which may include hospitalization, hematological support, and aggressive hydration and anti-diarrheal therapy. Hemodialysis is unlikely to be effective due to the high protein binding of capecitabine and its metabolites.
Storage
- Store at room temperature, 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
- Keep the tablets in their original blister packaging and out of the reach of children and pets.
- Protect from moisture and light.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content is based on the product’s prescribing information but may not be exhaustive.
Reviews
Clinical oncologists regard Xeloda as a pivotal agent in modern chemotherapy regimens. Its oral bioavailability and favorable toxicity profile, compared to historical IV 5-FU protocols, have made it a standard of care in many clinical scenarios. While hand-foot syndrome and gastrointestinal disturbances are common management challenges, its efficacy and the benefit of outpatient administration are consistently highlighted in clinical practice and literature. Patient-reported outcomes often emphasize the significant quality-of-life improvement associated with avoiding frequent clinic visits for infusions.