Trifluridine; Tipiracil Tablets

What is this medication?

TRIFLURIDINE; TIPIRACIL (trye FLURE i deen; tip EER a sil) treats stomach cancer and colorectal cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Lonsurf

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• History of low blood counts caused by a medication
• Infection, such as chickenpox, cold sores, herpes
• Kidney disease
• Liver disease
• Low blood counts, such as low white cells, platelets, red cells
• Recent or ongoing radiation therapy
• An unusual or allergic reaction to trifluridine, tipiracil, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication comes in two strengths, and your care team may prescribe both strengths for your prescribed dose. Take this medication by mouth with a glass of water. Take as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take this medication with food. Keep taking it unless your care team tells you to stop.

Handling this medication may be harmful. Wash your hands before and after touching the medication or the bottle. Wear gloves while touching the medication or bottle. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss or vomit a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 6 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 6 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose.

Do not breastfeed while taking this medication and for 1 day after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Loss of appetite
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. If kept outside the original container, get rid of any unused medication after 30 days. If kept in the original container, get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.