Xeloda: Targeted Oral Chemotherapy for Gastrointestinal and Breast Cancers
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Synonyms | |||
Xeloda (capecitabine) is an orally administered prodrug chemotherapeutic agent specifically designed for selective activation within tumor tissue. As a fluoropyrimidine carbamate, it offers a targeted mechanism of action that converts to 5-fluorouracil (5-FU) preferentially at the tumor site, thereby maximizing antitumor efficacy while potentially minimizing systemic exposure. This innovative delivery system represents a significant advancement in convenience and precision oncology, providing patients with an effective treatment option that can be administered outside clinical settings. Xeloda is indicated for adjuvant and metastatic treatment of colorectal cancer, metastatic breast cancer, and metastatic gastric cancer, often serving as either monotherapy or combination therapy based on clinical guidelines and individual patient factors.
Features
- Orally administered prodrug of 5-fluorouracil (5-FU)
- Selective activation to 5-FU by thymidine phosphorylase in tumor tissues
- Available in 150 mg and 500 mg film-coated tablets
- Convenient twice-daily dosing regimen
- Demonstrated efficacy in multiple gastrointestinal and breast malignancies
- Established safety profile with manageable toxicity spectrum
Benefits
- Enables outpatient treatment with reduced hospital visits compared to intravenous chemotherapy
- Provides targeted drug delivery with potentially reduced systemic toxicity
- Offers flexible dosing that can be adjusted based on individual tolerance
- Demonstrates proven efficacy in both adjuvant and metastatic settings
- Supported by extensive clinical trial data across multiple cancer types
- May be combined with other chemotherapeutic agents for enhanced treatment regimens
Common use
Xeloda is primarily indicated for the adjuvant treatment of Dukes’ C colon cancer following complete resection of the primary tumor when fluoropyrimidine therapy alone is preferred. It is also approved for first-line treatment of metastatic colorectal cancer, either as monotherapy or in combination with other chemotherapeutic agents. In metastatic breast cancer, Xeloda is indicated for patients resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen, or resistant to paclitaxel when further anthracycline therapy is not indicated. Additionally, it is used in the treatment of metastatic gastric cancer in combination with platinum-based chemotherapy.
Dosage and direction
The recommended dosage of Xeloda is 1250 mg/m² administered orally twice daily (morning and evening) for 2 weeks followed by a 1-week rest period, given as 3-week cycles. The tablets should be swallowed whole with water within 30 minutes after a meal. Dosage adjustments are recommended based on body surface area, and subsequent doses should be modified according to toxicity grades observed in the previous cycle. For patients with moderate renal impairment (creatinine clearance 30-50 mL/min), the recommended starting dose is 75% of the standard dose. Xeloda is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min).
Precautions
Patients receiving Xeloda require careful monitoring for diarrhea, which may become severe and lead to dehydration, electrolyte imbalance, and renal impairment. Hand-foot syndrome (palmar-plantar erythrodysesthesia) may occur and can be managed with dose modification, topical emollients, and pyridoxine supplementation. Regular monitoring of complete blood counts is essential to detect neutropenia, thrombocytopenia, and anemia. Cardiac monitoring is advised due to potential cardiotoxicity including myocardial infarction, angina, dysrhythmias, and cardiac arrest. Patients with dihydropyrimidine dehydrogenase (DPD) deficiency may experience severe, life-threatening toxicity and require dose adjustment or alternative therapy.
Contraindications
Xeloda is contraindicated in patients with known hypersensitivity to capecitabine or any component of the formulation, or to 5-fluorouracil. It must not be administered to patients with severe renal impairment (creatinine clearance below 30 mL/min). Patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity should not receive Xeloda. Concomitant administration with sorivudine or its chemically related analogues such as brivudine is absolutely contraindicated due to risk of severe and potentially fatal toxicity.
Possible side effect
Common adverse reactions (≥10%) include diarrhea, hand-foot syndrome, nausea, vomiting, stomatitis, fatigue, pyrexia, decreased appetite, and hyperbilirubinemia. Hematologic toxicities may include neutropenia, thrombocytopenia, and anemia. Less frequent but serious side effects include severe diarrhea requiring hospitalization, cardiotoxicity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, and neurotoxicity. Ophthalmologic effects such as conjunctivitis, eye irritation, and blurred vision have been reported. Hepatic toxicity including hyperbilirubinemia and elevated liver enzymes may occur.
Drug interaction
Xeloda may interact with warfarin, requiring frequent monitoring of INR and prothrombin time due to increased risk of bleeding. Concomitant use with phenytoin may increase phenytoin levels, necessitating therapeutic drug monitoring. Drugs that induce or inhibit cytochrome P450 enzymes, particularly CYP2C9, may affect Xeloda metabolism. Antacids may alter the absorption of capecitabine. Live vaccines should be avoided during treatment due to immunosuppression. Concomitant use with leucovorin may enhance toxicity without proven efficacy benefit.
Missed dose
If a dose of Xeloda is missed, the patient should not take the missed dose at the next scheduled time. Instead, they should continue with the next prescribed dose at the regularly scheduled time. Doubling of doses to make up for missed doses is strictly contraindicated. Patients should be instructed to maintain a dosing diary and contact their healthcare provider for specific guidance if multiple doses are missed or if dosing irregularities occur.
Overdose
Overdose of Xeloda may manifest as nausea, vomiting, diarrhea, gastrointestinal irritation and bleeding, bone marrow depression, and acute renal failure. Management should include immediate discontinuation of the drug and initiation of supportive care. Hematologic support with growth factors and blood product transfusion may be necessary. Dialysis may be considered, though the effectiveness in removing capecitabine and its metabolites is limited. Antidotes for fluoropyrimidine overdose, such as uridine triacetate, may be administered under specialized medical supervision.
Storage
Xeloda tablets should be stored at room temperature between 15°C to 30°C (59°F to 86°F) in their original container. The medication must be kept away from moisture and light and should not be stored in bathroom cabinets or other humid areas. Keep out of reach of children and pets. Do not use tablets that show signs of deterioration, discoloration, or damage to the packaging. Proper disposal of unused medication should follow local regulations for cytotoxic drugs.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals based on individual patient characteristics and current clinical guidelines. The prescribing information provided here may not include all possible uses, directions, precautions, or interactions. Patients should consult their healthcare provider for complete information about their specific medical condition and treatment options. Dosage adjustments and treatment modifications should only be made under medical supervision.
Reviews
Clinical studies have demonstrated Xeloda’s efficacy in multiple Phase III trials. In metastatic colorectal cancer, Xeloda monotherapy showed equivalent efficacy to intravenous 5-FU/leucovorin with a favorable safety profile. The X-ACT trial established its non-inferiority to intravenous 5-FU/LV in the adjuvant treatment of colon cancer. In metastatic breast cancer, studies have shown response rates of 15-25% in heavily pretreated patients. Real-world evidence supports its tolerability and effectiveness in appropriately selected patient populations, though individual responses may vary based on tumor characteristics and patient factors.