Uses of Trifluridine and Tipiracil:

• It is used to treat colorectal cancer.
• It is used to treat stomach cancer.

What do I need to tell my doctor BEFORE I take Trifluridine and Tipiracil?

• If you are allergic to trifluridine and tipiracil; any part of trifluridine and tipiracil; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease or raised liver enzymes.
• If you are breast-feeding. Do not breast-feed while you take trifluridine and tipiracil and for 1 day after your last dose.

This is not a list of all drugs or health problems that interact with trifluridine and tipiracil.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take trifluridine and tipiracil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Trifluridine and Tipiracil?

• Tell all of your health care providers that you take trifluridine and tipiracil. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Very bad and sometimes life-threatening blood and bone marrow problems like anemia, low platelet counts, or low white blood cell counts have happened with trifluridine and tipiracil. Change in dose or even stopping the drug may be needed if any of these side effects happen. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you are 65 or older, use trifluridine and tipiracil with care. You could have more side effects.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start trifluridine and tipiracil to show that you are NOT pregnant.
• Women must use birth control while taking trifluridine and tipiracil and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking trifluridine and tipiracil and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is this medicine (Trifluridine and Tipiracil) best taken?

Use trifluridine and tipiracil as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take trifluridine and tipiracil with food.
• Swallow whole. Do not chew, break, or crush.
• Wash your hands after use.
• If someone else is giving you trifluridine and tipiracil, be sure that person wears gloves to avoid contact with trifluridine and tipiracil.
• This medicine comes in 2 different strengths. The dose you get may be made up of 2 different strengths. Be sure to take trifluridine and tipiracil as you have been told.
• Keep taking trifluridine and tipiracil as you have been told by your doctor or other health care provider, even if you feel well.
• If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.

What are some other side effects of Trifluridine and Tipiracil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Feeling tired or weak.
• Stomach pain.
• Mouth irritation or mouth sores.
• Change in taste.
• Diarrhea, throwing up, upset stomach, and feeling less hungry are common with trifluridine and tipiracil. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Trifluridine and Tipiracil?

• Store in the original container at room temperature.
• If stored outside of the original container, throw away any part not used after 30 days.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about trifluridine and tipiracil, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.