Xeloda

Colorectal Cancer

Xeloda is commonly used to treat cancer of the colon or rectum. It may be prescribed in the following situations:

• Adjuvant treatment: To help prevent colon cancer from coming back after a patient has had surgery to remove the primary tumor.
• Metastatic disease: To treat colorectal cancer that has spread to other parts of the body.

Breast Cancer

This medication is used for breast cancer that has spread (metastatic) and has not responded to other chemotherapy treatments. It may be used:

• As a single therapy (monotherapy).
• In combination with other medications, such as docetaxel.

Other Cancers

Xeloda is also used to treat other types of cancer affecting the digestive system, including:

• Stomach (gastric) cancer.
• Esophageal cancer.
• Pancreatic cancer.

In these cases, it may be used as a first-line treatment or when other treatments are no longer effective.

Mechanism of Action

Xeloda is classified as an antimetabolite. It is administered as an inactive prodrug, meaning it must be processed by the body before it can begin fighting cancer. After the medication is ingested, enzymes in the liver and within tumor cells convert it into 5-fluorouracil (5-FU), which is the active chemotherapy agent.

This conversion process is designed to be more active within tumor cells because they often have higher concentrations of the specific enzymes needed to activate the drug compared to healthy cells.

Targeting Cancer Growth

Once the medication has been converted into its active form, it works by mimicking the natural building blocks used for cell growth. It interferes with the cancer cells in the following ways:

• DNA Interference: The drug prevents cancer cells from making new DNA, which is required for cells to divide and create new copies of themselves.
• RNA Disruption: It also interferes with the production of RNA, which cells need to build proteins and maintain their basic functions.

By blocking these essential processes, the medication slows down or stops the growth of cancer cells. Because cancer cells typically divide more rapidly than healthy cells, they are more significantly affected by this treatment.

Common Side Effects

Many individuals taking Xeloda experience side effects that are generally manageable. Common symptoms include:

• Nausea, vomiting, or stomach pain
• Constipation or loss of appetite
• Tiredness, weakness, or dizziness
• Headache or difficulty sleeping
• Back, joint, or muscle pain
• Eye irritation or increased tearing
• Changes in taste

Serious Side Effects

Certain side effects require prompt medical attention. Contact your doctor immediately if you notice:

• Hand-foot syndrome: Redness, swelling, pain, tingling, or peeling skin on the palms of the hands or soles of the feet.
• Severe diarrhea: An increase of four or more bowel movements per day compared to your usual routine.
• Dehydration: Symptoms such as extreme thirst, dry mouth, or decreased urination.
• Signs of infection: Fever, chills, or a persistent sore throat.
• Heart issues: Chest pain, irregular heartbeat, or sudden shortness of breath.
• Liver problems: Yellowing of the eyes or skin (jaundice) or dark-colored urine.
• Abnormal bleeding: Unusual bruising, nosebleeds, or blood in the stool.

Boxed Warning: Interaction with Blood Thinners

Xeloda can interact significantly with blood-thinning medications such as warfarin. This interaction can cause a sudden increase in blood clotting time, which may lead to severe bleeding or death. Frequent monitoring of blood clotting levels (PT/INR) is necessary for individuals taking both medications.

Severe Diarrhea and Dehydration

This medication can cause severe diarrhea, which may lead to life-threatening dehydration and kidney failure. Treatment may need to be paused or the dosage adjusted if diarrhea becomes frequent or severe. Maintaining adequate fluid intake is essential.

Hand-Foot Syndrome

Hand-foot syndrome is a common skin reaction that causes redness, swelling, pain, or peeling on the palms of the hands and the soles of the feet. If the condition becomes severe enough to interfere with daily activities, the medication may need to be temporarily stopped.

Heart Complications

Serious heart-related issues, including chest pain, heart rhythm changes, and heart attacks, have been reported. These risks are generally higher for individuals with a history of coronary artery disease.

Additional Precautions

• Blood Disorders: Xeloda can lower white blood cell and platelet counts, which increases the risk of infection and bleeding.
• Pregnancy and Fertility: This medication can cause fetal harm. It is not recommended for use during pregnancy, and effective birth control should be used during treatment.
• Kidney and Liver Function: Individuals with severe kidney disease should not use Xeloda. Those with liver impairment require close medical supervision.
• DPD Deficiency: People with a rare condition called dihydropyrimidine dehydrogenase (DPD) deficiency are at a significantly higher risk for severe or life-threatening toxicity from this drug.

Pregnancy and Fertility

Xeloda may cause serious harm or birth defects if taken during pregnancy. Healthcare providers typically advise using effective birth control during treatment and for a specific period after the final dose to prevent pregnancy.

Men with partners who can become pregnant should also use effective contraception during treatment and for a period after stopping the medication. This medication may also affect fertility in both men and women, which should be discussed with a doctor before starting treatment.

Breastfeeding

It is not known whether Xeloda passes into breast milk. Due to the risk of serious side effects in a nursing infant, breastfeeding is not recommended while taking this medication and for a period of time after the last dose. Patients should consult their healthcare team regarding the safest timeline for breastfeeding after treatment ends.

Dosage Forms

Xeloda is available as a film-coated tablet to be taken by mouth. It is not currently available in other forms such as liquids or injections.

When taking this medication, patients should follow these guidelines:

• Swallow the tablets whole with water.
• Take the dose within 30 minutes after finishing a meal.
• Do not crush or break the tablets.

FDA Approval and Indications

Xeloda was first approved by the FDA in 1998. It is indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy for stage III colon cancer. It is also approved for metastatic breast cancer, used either as a single agent or in combination with docetaxel. In December 2022, the FDA approved updated labeling for capecitabine that included new indications for gastric, esophageal, pancreatic, and biliary tract cancers.

Boxed Warning

Xeloda carries a boxed warning regarding its interaction with warfarin and other coumarin-derivative anticoagulants. This interaction can cause a clinically significant increase in prothrombin time (PT) and International Normalized Ratio (INR), which may lead to severe or fatal bleeding episodes. This risk can occur during treatment and up to one month after the last dose of Xeloda.

Monitoring and Safety

Due to the risk of drug interactions, the FDA requires close monitoring of patients who are taking both Xeloda and oral anticoagulants. Healthcare providers must frequently check blood clotting levels and adjust anticoagulant dosages as needed. Additionally, generic versions of Xeloda (capecitabine) are FDA-approved and available on the market.

Generic Availability

A generic version of Xeloda, known as capecitabine, is available. Generic medications are typically less expensive than brand-name drugs while providing the same therapeutic effect. Most insurance plans, including Medicare, may require or prefer the use of the generic version to help manage costs.

Factors Influencing Cost

The total price of treatment can vary based on several elements:

• Insurance Coverage: Out-of-pocket costs such as copayments or coinsurance are determined by an individual's specific insurance plan and its drug formulary.
• Dosage and Quantity: The strength of the tablets and the number of tablets required for each treatment cycle will affect the overall price.
• Pharmacy Selection: Prices can differ between retail pharmacies, mail-order services, and specialty pharmacies that often handle oncology medications.

Financial Assistance

Patients who have difficulty affording their medication may be eligible for financial assistance. Some manufacturers offer savings cards or patient assistance programs for those who meet specific income or insurance criteria. Healthcare providers or oncology social workers can often provide information on these resources to help reduce the financial burden of treatment.