Brand Name

Xeloda

Generic Name
Capecitabine
View Brand Information
FDA approval date: April 30, 1998
Classification: Nucleoside Metabolic Inhibitor
Form: Tablet

What is Xeloda (Capecitabine)?

Receiving a cancer diagnosis can be life-changing, and navigating treatment options often feels overwhelming. For many people, oral chemotherapy medications like Xeloda (capecitabine) offer a more convenient and manageable approach to cancer care. Instead of visiting the hospital for frequent infusions, patients can take this medication at home under their doctor’s supervision, maintaining a sense of normalcy during treatment. 

Xeloda is an oral chemotherapy drug used to treat several types of cancer, including breast cancer, colon cancer, and rectal cancer. It belongs to a class of drugs known as antimetabolites, which interfere with cancer cell growth by disrupting their ability to reproduce. Approved by the U.S. Food and Drug Administration (FDA), Xeloda has been widely used for more than two decades as a trusted part of many chemotherapy regimens. It may be prescribed on its own or combined with other cancer medicines, depending on the individual treatment plan. 

What does Xeloda do? 

Xeloda is designed to slow or stop the growth of cancer cells in the body. It is most often prescribed for: 

  • Metastatic breast cancer (especially after other treatments have failed) 
     
  • Colon cancer, particularly following surgery to prevent recurrence 
     
  • Metastatic colorectal cancer (cancer that has spread to other organs) 
     

For patients with breast or colorectal cancer, Xeloda can improve survival rates, help control tumor growth, and in some cases shrink existing tumors. Studies have shown that Xeloda is as effective as traditional intravenous chemotherapy for many patients, while offering the convenience of oral dosing (Mayo Clinic, 2024). 

Patients often report a better quality of life because they can take Xeloda at home instead of spending long hours in an infusion center. However, like all chemotherapy, it requires careful monitoring by healthcare professionals to manage potential side effects and ensure the best outcomes. 

How does Xeloda work? 

Xeloda works by interfering with how cancer cells grow and divide. After swallowing the pill, the body converts capecitabine into 5-fluorouracil (5-FU), a well-known chemotherapy agent directly inside the tumor tissue. 

This conversion process happens more in cancer cells than in healthy ones because tumors contain higher levels of a specific enzyme called thymidine phosphorylase. Once inside the tumor, 5-FU blocks an enzyme that cancer cells need to make DNA and RNA. Without these building blocks, the cells cannot divide and eventually die. 

This targeted activation of the drug helps minimize exposure to healthy tissues and may reduce some side effects compared to traditional intravenous chemotherapy. Clinically, this localized approach is significant because it allows higher concentrations of the active drug where it’s most needed at the tumor site while still being tolerable for patients. 

Xeloda side effects 

Like all chemotherapy medications, Xeloda can cause side effects, but not everyone experiences them to the same degree. Most are temporary and manageable with the right care plan. 

Common side effects include: 

  • Diarrhea 
     
  • Nausea and vomiting 
     
  • Fatigue or weakness 
     
  • Loss of appetite 
     
  • Hand-foot syndrome (redness, pain, or peeling on the palms and soles) 
     
  • Mouth sores 

Serious side effects (less common) include: 

  • Severe diarrhea or dehydration 
     
  • Chest pain or shortness of breath 
     
  • Signs of infection (fever, sore throat) 
     
  • Jaundice (yellowing of the skin or eyes, indicating possible liver issues) 
     
  • Confusion or dizziness (possible severe reaction) 

Because Xeloda affects rapidly dividing cells, it can also lower blood cell counts, increasing the risk of infection or bleeding. Routine blood tests help monitor these effects. 

Avoid Xeloda if you have severe kidney disease, allergies to capecitabine or 5-fluorouracil, or severe reactions to prior chemotherapy. It’s also contraindicated during pregnancy or breastfeeding due to potential harm to the baby.  

Seek immediate medical attention for chest pain, severe abdominal pain, uncontrollable vomiting, or allergic reactions (rash, swelling, breathing difficulty). Doctors can adjust doses or pause treatment for unmanageable side effects, allowing most patients to continue safely under supervision. 

Xeloda dosage 

Xeloda tablets are taken orally, usually twice daily with water after meals. Dosage and schedule vary based on cancer type, patient weight, and combination therapy. Treatment occurs in cycles: medication for set days, then rest. Take doses exactly as prescribed; do not double up on missed doses without medical advice. 

Doctors will conduct regular lab tests to monitor blood counts, liver, and kidney function, adjusting Xeloda dosage for safety and effectiveness. Older adults or those with impaired kidney function may need a lower starting dose. Always inform your doctor about all medications, supplements, and herbal products to prevent interactions. 

Does Xeloda have a generic version? 

Yes. Capecitabine, the generic form of Xeloda, is FDA-approved and widely available in the United States and internationally. The generic version contains the same active ingredient, dosage strength, and therapeutic effect as the brand-name drug. 

Generic medications, like capecitabine (generic Xeloda), are often more affordable and equally effective as brand-name versions. Confirm with your doctor or pharmacist to ensure consistency in your treatment. 

Conclusion 

Xeloda (capecitabine) is a powerful oral chemotherapy medication that gives patients flexibility and control during their cancer journey. By targeting cancer cells directly within the tumor, it effectively slows or stops their growth while allowing patients to maintain daily routines outside the hospital. 

Side effects are manageable with dose adjustments and medical care. Regular communication with your healthcare team is essential for tailored treatment and monitoring. 

Xeloda is an effective and convenient option for many breast or colorectal cancer patients. Stay informed and proactive for better treatment outcomes. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Xeloda (capecitabine) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Capecitabine (oral route) description and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Capecitabine: Drug information and side effects. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Antimetabolite chemotherapy overview. Retrieved from https://www.nih.gov 

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Brand Information

XELODA (capecitabine)
WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY and INCREASED RISK OF BLEEDING WITH CONCOMITANT USE OF VITAMIN K ANTAGONISTS
Increased risk of serious adverse reactions or death in patients with complete DPD deficiency
• Test patients for genetic variants of
Increased risk of bleeding with concomitant use of Vitamin K antagonists
• Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking XELODA concomitantly with oral vitamin K antagonists, such as warfarin [see
• Clinically significant increases in prothrombin time (PT) and international normalized ratio (INR) have been reported in patients who were on stable doses of a vitamin K antagonist at the time XELODA was introduced. These events occurred in patients with and without liver metastases.
• Monitor INR more frequently and adjust the dose of the vitamin K antagonist as appropriate [see
1DOSAGE FORMS AND STRENGTHS
Tablets, film-coated:
  • 150 mg: biconvex, oblong, light-peach colored, with "XELODA" on one side and "150" on the other
  • 500 mg: biconvex, oblong, peach colored, with "XELODA on one side and "500" on the other
2CONTRAINDICATIONS
XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Cardiotoxicity
  • Diarrhea
  • Dehydration
  • Renal Toxicity
  • Serious Skin Toxicities
  • Palmar-Plantar Erythrodysesthesia Syndrome
  • Myelosuppression
  • Hyperbilirubinemia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of XELODA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye: lacrimal duct stenosis, corneal disorders including keratitis
Hepatobiliary: hepatic failure
Immune System Disorders: angioedema
Nervous System: toxic leukoencephalopathy
Renal & Urinary: acute renal failure secondary to dehydration including fatal outcome
Skin & Subcutaneous Tissue: cutaneous lupus erythematosus, severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN), persistent or severe PPES can eventually lead to loss of fingerprints
4OVERDOSAGE
Administer uridine triacetate within 96 hours for management of XELODA overdose.
Although no clinical experience using dialysis as a treatment for XELODA overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5'-DFUR, a low–molecular-weight metabolite of the parent compound.
5DESCRIPTION
Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C
Chemical Structure
Chemical Structure
Chemical Structure
Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C.
XELODA (capecitabine) is supplied as biconvex, oblong film-coated tablets for oral use. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in XELODA include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The peach or light peach film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, and synthetic yellow and red iron oxides.
6REFERENCES
1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
7HOW SUPPLIED/STORAGE AND HANDLING
XELODA (capecitabine) tablets are supplied as follows:
  • 150 mg, biconvex, oblong, film-coated, light peach tablets with "XELODA" on one side and "150" on the other; available in bottles of 60 tablets (NDC 61269-470-60), individually packaged in a carton.
  • 500 mg, biconvex, oblong, film-coated, peach tablets with "XELODA" on one side and "500" on the other; available in bottles of 120 tablets (NDC 61269-475-12), individually packaged in a carton.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Carton
NDC 61269-470-60
Xeloda
150 mg
Each tablet contains 150 mg
Rx only
Warning: Hazardous Drug
60 tablets
CHEPLAPHARM
PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Carton
10PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Carton
NDC 61269-475-12
Xeloda® 
(capecitabine)
Tablets
500 mg
Each tablet contains 500 mg
capecitabine.
Rx only
Warning: Hazardous Drug
120 tablets
CHEPLAPHARMPACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL