Tipiracil and trifluridine is a combination cancer medicine used to treat colorectal cancer, or cancer of the stomach and lower esophagus.

tipiracil and trifluridine is used when the cancer has spread to other parts of the body (metastatic).

Tipiracil and trifluridine is usually given after other treatments have failed.

Tipiracil and trifluridine may also be used for purposes not listed in this medication guide.

tipiracil and trifluridine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, body aches, or unusual bleeding or bruising.

You will need blood tests before and during treatment with tipiracil and trifluridine.

Before and during treatment with tipiracil and trifluridine, you will need blood tests. The timing of these tests is very important.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with food.

Tipiracil and trifluridine is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

Swallow the tablet whole and do not crush, chew, or break it.

To get the correct dose, you may need to take 2 or more tablets that are different strengths and colors. Follow your doctor's dosing instructions very carefully.

Wash your hands after handling tipiracil and trifluridine tablets. Caregivers who touch or handle the tablets should wear rubber gloves.

If you vomit shortly after taking tipiracil and trifluridine, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Tipiracil and trifluridine doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight.

Store tablets in their original container at room temperature, away from moisture and heat. Throw away any unused tablets after 30 days if you do not store them in the original container.

Ask your pharmacist how to safely dispose of tablets you no longer need.

Tell your doctor if you have ever had:

• kidney disease; or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Tipiracil and trifluridine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use tipiracil and trifluridine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using tipiracil and trifluridine.

You should not breastfeed while using this medicine, and for at least 24 hours after your last dose.

Call your doctor for instructions if you miss a dose.

Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tipiracil and trifluridine may cause serious side effects. Call your doctor at once if you have:

• low levels of platelets in your blood--easy bruising, unusual bleeding, purple or red spots under your skin;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Serious side effects may be more likely in older adults.

Common side effects of tipiracil and trifluridine may include:

• stomach pain, loss of appetite;

• nausea, vomiting, diarrhea;

• fever; or

• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect tipiracil and trifluridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.