Tipiracil/Trifluridine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat colorectal cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe liver problems or increase your risk for infections or bleeding. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); nucleoside metabolic inhibitor/thymidine phosphorylase inhibitor

Generic and brand names: tipiracil/trifluridine, oral; Lonsurf

What is this medicine used for?

This medicine is taken by mouth to treat advanced colorectal cancer that has spread to other parts of the body. This medicine is used when other cancer medicines have not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Anemia
• Kidney or liver problems
• Low white blood cell or low platelet counts

Pregnancy and breastfeeding: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant while taking this medicine, contact your healthcare provider right away. Use effective birth control during treatment with this medicine. Do not breast-feed while you are taking this medicine.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine and for at least 3 months after you stop taking it.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine within 1 hour of your morning and evening meals. Wash your hands after handling the tablets. Any other people who handle this medicine should wear gloves.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: hoarseness; severe diarrhea; dry mouth; severe tiredness; skin rash, redness, swelling, or blistering.

What should I watch out for?

This medicine may lower the number of certain types of blood cells in your body. You may get infections or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. If you develop a fever or other signs of infection, or have any unusual bruising or bleeding, contact your healthcare provider right away.

Adults over the age of 65 may be at greater risk for side effects.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unexplained bruising or bleeding; blood in the urine or bowel movements; black or tarry bowel movements; menstrual bleeding that is heavier than normal; severe dizziness or fainting; unexplained tiredness or weakness; severe stomach pain or swelling; severe nausea, vomiting, or diarrhea; fever; body aches.

Other: Mouth sores, mild diarrhea, mild stomach cramps, nausea, decreased appetite, hair loss, change in sense of taste.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature in the bottle that it comes in. The original container has a small packet to help keep your medicine dry. Do not throw away the packet. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. If you store the medicine outside of the original bottle, discard it after 30 days.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.