tipiracil and trifluridine

What is the most important information I should know about tipiracil and trifluridine?

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

What is tipiracil and trifluridine?

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

This medicine 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.

What should I discuss with my healthcare provider before taking tipiracil and trifluridine?

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.

• 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.

How should I take tipiracil and trifluridine?

Before and during treatment with this medicine, 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.

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.

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.

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.

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

What happens if I miss a dose?

Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking tipiracil and trifluridine?

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

What are the possible side effects of tipiracil and trifluridine?

• 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 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.

What other drugs will affect tipiracil and trifluridine?

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.

Where can I get more information?

Your pharmacist can provide more information about tipiracil and trifluridine.