Capecitabine

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Generic Name: Capecitabine Brand Name(s): Generics only. No brands available.

Uses

What is Capecitabine used for?

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

How should I take Capecitabine?

Take this medication by mouth as directed by your doctor, usually 2 times a day; once in the morning and once in the evening. Swallow the tablets whole with a full glass of water (8 ounces/240 milliliters) within 30 minutes after a meal. Do not crush or split the tablets. If you have trouble swallowing the tablets whole, ask your health care professional for advice. Your doctor may direct you to take this medication in a treatment cycle. Carefully follow your doctor’s instructions.

The dosage is based on your medical condition, body size, and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

How do I store Capecitabine?

Capecitabine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Capecitabine in the bathroom or the freezer. There may be different brands of Capecitabine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Capecitabine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Capecitabine?

Before taking capecitabine, tell your doctor or pharmacist if you are allergic to it; or to 5-fluorouracil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lack of a certain enzyme (dihydropyrimidine dehydrogenase – DPD), blood disorders (such as bone marrow suppression), heart problems (such as heart failure), kidney disease, liver problems.

Capecitabine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Get medical help right away if you get sunburned or have skin blisters/redness.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this medication, especially nausea, vomiting, diarrhea, and hand-foot syndrome.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using capecitabine. Capecitabine may harm an unborn baby. Ask about reliable forms of birth control. Women of childbearing age should use reliable forms of birth control during treatment and for 6 months after the last dose. Men with female partners of childbearing age should use reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner become pregnant, talk to your doctor right away about capecitabine’s risks and benefits.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended during treatment and for 2 weeks after the last dose. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Capecitabine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Capecitabine. Capecitabine is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Capecitabine?

Nausea, vomiting, loss of appetite, constipation, tiredness, weakness, headache, dizziness, trouble sleeping, or changes in taste may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect of this medication. Drink plenty of fluids unless directed otherwise. Your doctor may also prescribe medication (such as loperamide) to help lessen diarrhea. Vomiting or diarrhea that doesn’t stop may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, or dizziness/lightheadedness.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended. Also, temporary nail changes may occur.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Stop taking capecitabine and tell your doctor right away if any of these very serious side effects occur: severe nausea/vomiting (vomiting 2 or more times per day, unable to eat or keep food/fluids in your stomach), painful redness/swelling/sores in mouth or on your tongue.

Capecitabine may make you develop a skin problem called hand-foot syndrome. To help prevent this, protect your hands and feet from heat or increased pressure. Avoid activities such as using hot dishwater, taking tub baths, jogging, long walks, or using garden or household tools such as screwdrivers. Symptoms may include pain, swelling, redness, blisters, or numbness of the hands/feet. Your doctor may prescribe medication (such as balm) to help with symptoms. If symptoms affect your usual activities, get medical help right away.

For men and women of childbearing age, this medication may affect your ability to have children. Ask your doctor for more details.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat that doesn’t go away, fever, chills, cough).

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, mental/mood changes (such as depression), swelling of the ankles/feet, vision changes, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine.

Get medical help right away if you have any very serious side effects, such as: chest/jaw/left arm pain, unusual sweating, fainting, slow/fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash/blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Capecitabine?

Capecitabine is very similar to fluorouracil. Do not use medications containing fluorouracil while using capecitabine.

Capecitabine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Capecitabine?

Capecitabine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Capecitabine?

Capecitabine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Capecitabine.

What is the dose of Capecitabine for an adult?

Usual Adult Dose for Colorectal Cancer

MONOTHERAPY:

For first line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred:

-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles

ADJUVANT TREATMENT IN PATIENTS WITH DUKES’ C COLON CANCER:

-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles for a total of 8 cycles (24 weeks)

Comments:

-The tablets should be swallowed whole with water within 30 minutes after a meal.

Use:

Colorectal Cancer:

-As monotherapy for adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred; this drug was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS); physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing this drug as a single-agent in the adjuvant treatment of Dukes’ C colon cancer

-As first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred; combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone; survival benefit over 5-FU/LV has not been demonstrated with this drug as monotherapy; use of this drug instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage

Usual Adult Dose for Breast Cancer

MONOTHERAPY:

-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period combined with docetaxel 75 mg/m2 as a 1 hour IV infusion, every 3 weeks

IN COMBINATION WITH DOCETAXEL:

-RECOMMENDED DOSE: 1250 mg/m2 orally 2 times a day (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1 week rest period given as 3 week cycles

Comments:

-The manufacturer prescribing information for docetaxel should be consulted for premedication advice.

-The tablets should be swallowed whole with water within 30 minutes after a meal.

Use:

Breast Cancer:

-In combination with docetaxel for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy

-As monotherapy for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents); resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen

Renal Dose Adjustments

-Mild renal impairment (CrCl 51 to 80 mL/min): No adjustment recommended

-Moderate renal impairment (CrCl 30 to 50 mL/min): Reduce the capecitabine starting dose to 75% (from 1250 mg/m2 to 950 mg/m2 orally 2 times a day)

-Severe renal impairment (CrCl less than 30 mL/min): Contraindicated

Liver Dose Adjustments

-Mild to moderate hepatic impairment due to liver metastases: No adjustment recommended

-Severe hepatic impairment: Data not available

Dose Adjustments

-Patients should be carefully monitored for toxicity and the dose of this drug should be modified as necessary to accommodate individual patient tolerance to treatment.

-Toxicity may be managed by symptomatic treatment, dose interruptions, and adjustment of dose.

-Once the dose has been reduced, it should not be increased at a later time.

-Doses omitted for toxicity should not be replaced. Instead the patient should resume the planned treatment cycles.

-The dose of phenytoin and the dose of coumarin derivative anticoagulants may need to be reduced when either drug is administered concomitantly with this drug.

MONOTHERAPY (metastatic colorectal cancer, adjuvant colorectal cancer, metastatic breast cancer):

GRADE 1 ADVERSE EVENTS: Dose modifications are not recommended

GRADE 2 ADVERSE EVENTS:

-First appearance: Interrupt therapy until resolved to grade 0 or 1 and maintain the dose level for the next treatment at 100%

-Second appearance: Interrupt therapy until resolved to grade 0 or 1 and maintain the dose level for the next treatment at 75%

-Third appearance: Interrupt therapy until resolved to grade 0 or 1 and maintain the dose level for the next treatment at 50%

-Fourth appearance: Discontinue therapy permanently

GRADE 3 ADVERSE EVENTS:

-First appearance: Interrupt therapy until resolved to grade 0 or 1 and begin the next cycle at 75% of the starting dose

-Second appearance: Interrupt therapy until resolved to grade 0 or 1 and begin the next cycle at 50% of the starting dose

-Third appearance: Discontinue therapy permanently

GRADE 4 ADVERSE EVENTS:

-First appearance: Discontinue therapy permanently, or if the physician deems it to be in the patient’s best interest to continue, interrupt until resolved to grade 0 or 1 and begin the next cycle at 50% of the starting dose

IN COMBINATION WITH DOCETAXEL (Metastatic Breast Cancer): Dose modifications of capecitabine for toxicity should be made according to the monotherapy schedule above. At the beginning of a treatment cycle, if a treatment delay is indicated for either capecitabine or docetaxel, then administration of both agents should be delayed until the requirements for restarting both drugs are met.

DOCETAXEL DOSE ADJUSTMENTS (IN COMBINATION WITH CAPECITABINE):

GRADE 1 ADVERSE EVENTS: Dose modifications are not recommended

GRADE 2 ADVERSE EVENTS:

-First appearance: Interrupt therapy until resolved to grade 0 or 1 and resume therapy with the original dose of 75 mg/m2

-Second appearance: Interrupt therapy until resolved to grade 0 or 1 and resume therapy at 55 mg/m2

-Third appearance: Discontinue therapy with docetaxel

GRADE 3 ADVERSE EVENTS:

-First appearance: Interrupt therapy until resolved to grade 0 or 1 and resume therapy at 55 mg/m2

-Second appearance: Discontinue therapy with docetaxel

GRADE 4 ADVERSE EVENTS:

-Discontinue therapy with docetaxel

Other Comments

Administration advice:

-Tablets should not be chewed, crushed, or divided.

-Tablets should be swallowed with water within 30 minutes after a meal.

-The relevant manufacturer prescribing information should be consulted for premedication advice when used concomitantly with other antineoplastic agents.

Monitoring:

-Cardiovascular: Cardiotoxicity (e.g., myocardial infarction, angina, dysrhythmias, cardiac arrest, cardiac failure, ECG changes), particularly in patients with a history of coronary artery disease.

-Dermatologic: Hand and foot syndrome

-Gastrointestinal: Diarrhea, nausea and vomiting, stomatitis

-Hematologic: Full blood count

-Hepatic: Liver function

-Metabolic: Dehydration

-Renal: Renal function

IV compatibility:

-Refer to the manufacturer product information.

General:

Patients receiving therapy should be monitored by a physician experienced in the use of cancer chemotherapeutic agents.

-Most adverse reactions are reversible and do not need to result in discontinuation, although doses may need to be withheld or reduced.

-This drug can induce diarrhea which may be severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. Standard antidiarrheal treatments (e.g., loperamide) are recommended. Depending on the severity of the diarrhea, treatment may need to be interrupted followed by a decrease in dosage when treatment is resumed.

-Patients aged 80 years or older may experience more grade 3 or 4 adverse events when this drug is used as monotherapy compared with younger patients.

-Patients aged 65 years or older may experience more grade 3 or 4 adverse events when this drug is used in combination with other agents compared with younger patients.

What is the dose of Capecitabine for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Capecitabine available?

Capecitabine is available in the following dosage forms and strengths:

  • Oral tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Capecitabine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: June 4, 2018 | Last Modified: June 4, 2018

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