Trifluridine and Tipiracil

WHY is this medicine prescribed?

The combination of trifluridine and tipiracil is used alone or in combination with bevacizumab (Avastin) to treat colon (large intestine) or rectal cancer that has spread to other parts of the body in people who have already been treated with other chemotherapy medications or cannot receive these chemotherapy medications. The combination of trifluridine and tipiracil is also used to treat certain types of stomach cancer or cancer located in the area where the stomach meets the esophagus (the tube between the throat and stomach) that has spread to other parts of the body in people who have already received at least two other chemotherapy treatments. Trifluridine is in a class of medications called thymidine-based nucleoside analogues. It works by stopping the growth of cancer cells. Tipiracil is in a class of medications called thymidine phosphorylase inhibitors. It works by slowing the breakdown of trifluridine by the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of trifluridine and tipiracil comes as a tablet to take by mouth. It is usually taken twice a day with food. Trifluridine and tipiracil is usually given on days 1, 2, 3, 4, and 5, followed by a 2-day break, and then on days 8, 9, 10, 11, and 12 of a 28 day treatment cycle. This 28-day cycle may be repeated depending on how well this medication works for you and the side effects you experience. Take trifluridine and tipiracil at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take trifluridine and tipiracil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking trifluridine and tipiracil, do not take another dose. Continue your regular dosing schedule.

Trifluridine and tipiracil tablets come in two different strengths. Your doctor may want you to take a combination of both strengths of tablets to make up your full dose. Be sure that you know what each type of tablet looks like and how many you are to take of each. Ask your doctor or pharmacist if you have any questions.

Your doctor may delay or permanently stop your treatment or decrease your dose of trifluridine and tipiracil depending on the side effects that you experience. Be sure to talk to your doctor about how you are feeling during your treatment. Do not stop taking trifluridine and tipiracil without talking to your doctor.

Wash your hands after handling trifluridine and tipiracil tablets. If someone else is handling your trifluridine and tipiracil tablets, they should wear rubber or latex gloves so that their skin does not come into contact with the tablets.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking trifluridine and tipiracil,

• tell your doctor and pharmacist if you are allergic to trifluridine and tipiracil, any other medications, or any of the ingredients in trifluridine and tipiracil tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had low white blood cell counts, anemia (a lower than normal number of red blood cells), bleeding problems, or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant during your treatment with trifluridine and tipiracil. If you are female, you will need to have a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you are a man and your partner can become pregnant, you should use a condom while taking this medication, and for 3 months after your treatment. If you or your partner become pregnant while you are receiving trifluridine and tipiracil, call your doctor immediately. Trifluridine and tipiracil may harm the fetus.

• tell your doctor if you are breastfeeding. Your doctor will probably tell you not to breastfeed during your treatment and for 1 day after your last dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a dose of trifluridine and tipiracil, do not take another dose to make up for the missed dose. Call your doctor for instructions about what to do for a missed dose.

What SIDE EFFECTS can this medicine cause?

Trifluridine and tipiracil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• stomach pain
• constipation
• hair loss
• change in the way things taste
• loss of appetite
• mouth sores or swelling inside the mouth
• lack of energy
• excessive tiredness
• muscle or bone pain
• headache

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• fever, body aches, chills, or other signs of infection
• nausea, vomiting, diarrhea, or abdominal pain that is severe or does not go away
• weakness
• shortness of breath
• pale skin
• chest pain
• pain with deep breathing
• coughing up blood
• unusual bleeding or bruising

Trifluridine and tipiracil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

If you have stored this medication outside the container it came in, dispose of all unused tablets after 30 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to trifluridine and tipiracil.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.