Capecitabine

Capecitabine is a prescription drug used to treat breast, colon, or rectal cancer. It works by slowing or stopping the growth of cancer cells.

Capecitabine is available under the following different brand names: Xeloda.

Tablet

• 150 mg
• 500 mg

Dosage Considerations – Should be Given as Follows:

Duke Stage C Colon Cancer

Adjuvant therapy

• 1,250 mg/m² orally twice a day for 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 twice a day for 2 weeks every 21 days

Breast Cancer

Metastatic, resistant to paclitaxel, anthracyclines

• Monotherapy: 1250 mg/m2 twice a day for 2 weeks every 3 weeks
• Combo therapy with Docetaxel: 1250 m2 orally twice a day for 2 weeks every 3 weeks plus Docetaxel 75 mg/m2 1 hour intravenous infusion every 3 weeks

Administration

• Swallow with water within 30 minutes after a meal
• Dosage may need to be individualized to optimize patient management

Common side effects of capecitabine include:

• anemia
• back pain
• bloody, black, or tarry stools
• body aches
• chest pain
• chills
• constipation
• coughing up blood
• decreased appetite
• decreased low blood platelet count
• decreased white blood cells
• dehydration
• difficult or labored breathing
• dry mouth
• easy bruising or bleeding
• eye irritation
• fever
• flu symptoms
• hair loss
• headache
• inflamed and sore mouth
• lightheadedness
• loss of appetite
• mild skin rash
• nausea
• numbness or tingling in your hands or feet
• pain, tenderness, redness, swelling, blistering, or peeling skin on hands or feet
• pale skin
• rapid heart rate
• severe diarrhea
• shortness of breath
• stomach pain or upset
• swelling, rapid weight gain
• taste disturbance
• tired feeling
• trouble concentrating
• vomit that looks like coffee grounds
• vomiting
• weakness
• white patches or sores inside your mouth or lips
• yellowing of the skin or eyes (jaundice)

Postmarketing effects of capecitabine includes:

• acute kidney failure secondary to dehydration
• inflammation of the eye with severe pain
• skin lesions and/or rash (cutaneous lupus erythematosus)
• liver failure
• tear duct obstruction
• severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epiderman Necrolysis (TEN)
• white matter brain damage

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Capecitabine has no known severe interactions with other drugs.

Serious interactions of capecitabine include:

• adenovirus type 4 and 7 live, oral
• enoxaparin
• influenza virus vaccine trivalent, adjuvanted
• palifermin
• tofacitinib
• warfarin

Capecitabine has moderate interactions with 32 different drugs.

Minor interactions of capecitabine include:

• food
• maitake
• taurine
• vitamin A
• vitamin E

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

Capecitabine may increase the anticoagulant effects of warfarin increasing the international normalized ratio (INR) several days up to several months after initiating capecitabine or within one month after stopping the therapy.

Risk factors include patients over 60 years of age and cancer. Monitor closely.

This medication contains capecitabine. Do not take Xeloda if you are allergic to capecitabine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to capecitabine or fluorouracil (5-FU).

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Capecitabine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Capecitabine?"

Cautions

• May result in bleeding, death; monitor anticoagulant response (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
• May cause cardiomyopathy and acute decreases in left ventricular ejection fraction (LVEF)
• 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 below 1.5 x 10^9;/L or thrombocyte counts under 100 x 10^9;/L; if grade 3-4 neutropenia or thrombocytopenia occurs, stop therapy until condition resolves

Pregnancy and Lactation

• Use capecitabine during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk.
• It is unknown if capecitabine is distributed into breast milk, therefore it is not recommended if breastfeeding.