IMPORTANT AND COMMON SIDE EFFECTS OF TRIFLURIDINE/TIPIRACIL

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1 IMPORTANT AND COMMON SIDE EFFECTS OF TRIFLURIDINE/TIPIRACIL Trifluridine/Tipiracil (brand name: Lonsurf ) is a prescription medicine. One way it is used is to treat colon or rectal cancer (CRC) that has spread to other parts of the body and that has previously been treated with chemotherapy. GENERAL TIPS TO IDENTIFY AND MANAGE TRIFLURIDINE/TIPIRACIL SIDE EFFECTS: Side effects with trifluridine/tipiracil can occur at any time after starting this medication, but they are often the most severe within the first several weeks of treatment. It is important to pay close attention to how you feel during this time, and report any changes in your health or physical functioning to your doctor/nurse It is a good idea to record any symptoms you experience in a daily log or journal so you can see whether they are getting better, worse, or staying the same over time. Please bring this journal with you to share with your provider at follow-up appointments Your healthcare provider may want you to get your blood tested regularly. It is important that you always keep these appointments while taking this medicine TRIFLURIDINE/TIPIRACIL MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING: Low blood cell counts: Trifluridine/tipiracil often lowers the amount of white blood cells, red blood cells, and platelets in your blood. Without close monitoring and appropriate treatment these low blood cell counts can sometimes be severe and even life threatening Infection: Tell your doctor/nurse right away if you experience any signs/symptoms of infection, including: Fever Chills Body aches MOST COMMON SIDE EFFECTS One in 10 or more people who take trifluridine/tipiracil experience: Decreased appetite Diarrhea, loose bowel movements Fever Low platelet count Low red blood cell count Low white blood cell count Nausea Stomach (abdominal) pain Tiredness, weakness, fatigue Vomiting

2 The remaining portion of this handout focuses on a few of these side effects. It is not meant to provide comprehensive information on these potential side effects. Make sure to speak with your doctor/nurse about all potential side effects before starting any medication. LOW WHITE BLOOD CELL COUNT (NEUTROPENIA) More than two-thirds of patients taking trifluridine/tipiracil develop lower-than-normal white blood cell counts Over one-third experience severely low white blood cell levels White blood cells are important for fighting infection, so having low levels of these types of blood cells increases the risk of getting an infection Symptoms of an infection include: Fever (temperature higher than ), chills, body aches, runny nose, sore throat, cough, shortness of breath, pain or burning when urinating, having a sore that does not heal * Tell your doctor/nurse right away if you have any of these symptoms If your white blood cell counts are too low, your healthcare provider may delay your trifluridine/tipiracil dose, and then may reduce your dose or alter your dosing frequency You may also be prescribed medicine that increases your ability to produce white blood cells To reduce your risk of infection, wash your hands often with soap and water, and use sanitizing wipes to clean surfaces of objects you are in contact with Be careful not to cut yourself, including your cuticles or ingrown nails. Clean cuts immediately with warm water, soap, and an antiseptic Avoid large crowds and people who are sick Do not handle pet waste, and wear protective clothing when working in your yard Ask your doctor or nurse before having any dental procedures or receiving any vaccinations LOW RED BLOOD CELL COUNT (ANEMIA) Over three-quarters of patients develop lower-than-normal red blood cell counts after taking trifluridine/tipiracil Almost 1 in 5 experiences severely low red blood cell counts Red blood cells carry oxygen to your body s tissues. Having too few red blood cells means that your body may not receive enough oxygen to function properly Symptoms include: Fatigue, weakness, pale skin, irregular heartbeats, shortness of breath, dizziness or lightheadedness, chest pain, cold hands and feet, and headache

3 LOW RED BLOOD CELL COUNT (ANEMIA) cont. Your healthcare provider may prescribe a blood transfusion to treat a low red blood cell count You will also be evaluated for other health conditions to see if something else may causing your low red blood cell count (for example, you may have an iron or vitamin B12 deficiency). If another cause is identified, your doctor/nurse will treat that condition, if necessary Let your doctor/nurse know if you have any symptoms of low red blood cell count See below for ways that you can manage your tiredness and fatigue, which may be related to having low levels of red blood cells LOW PLATELET COUNT (THROMBOCYTOPENIA) Almost half of patients taking trifluridine/tipiracil develop lower than normal platelet levels About 1 in 20 experiences severely low platelet levels Platelets help your blood clot, so when your platelet levels are low you are at a higher risk of bleeding Symptoms include: Excessive and easy bruising, nose bleeds, bleeding gums, blood in your urine or stool, and any bleeding that won t stop If your platelet counts are too low, your healthcare provider may delay your trifluridine/tipiracil dose, and then may reduce your dose after that Your healthcare provider may also prescribe a platelet transfusion To prevent bleeding, use an electric razor rather than a straight edge or disposable razor for shaving Avoid activities that can result in injury, like contact sports and the use of sharp tools Do not take aspirin (acetylsalicylic acid), Aleve (naproxen), Motrin or Advil (ibuprofen), or any other over-the-counter medications/supplements without first speaking to your doctor/nurse, as these can all increase the risk of bleeding Use a soft-bristle toothbrush to brush your teeth, and talk to your doctor/nurse before flossing or using toothpicks TIREDNESS/FATIGUE Over half of patients experience some fatigue when taking trifluridine/tipiracil, and about 1 in 14 experiences severe tiredness/fatigue

4 TIREDNESS/FATIGUE cont. Tired eyes or legs, whole body tiredness, stiff shoulders, decreased or a lack of energy, inability to concentrate, weakness or malaise, boredom or lack of motivation, sleepiness, increased irritability, nervousness, anxiety or impatience Your nurse/doctor may evaluate you to see if there are other factors that might be contributing to your fatigue, in addition to your trifluridine/tipiracil treatment, and will treat those other factors appropriately - For example, your tiredness could be caused by low red blood cells (See section above about low red blood cells) They also may refer you to other specialists (for example, a nutritionist, psychologist) for psychosocial interventions If your fatigue is severe and not alleviated by lifestyle changes, your doctor/nurse may prescribe stimulant medications Contact your healthcare team if your fatigue develops or worsens between office visits Try to sleep at least 8 hours a night Conserve your energy for the daily activities that are most important to you Exercise lightly or remain active - Follow your doctor s guidelines for activity Avoid taking naps during the day or take naps that are less than 1 hour so you can sleep well at night Make time for friends/family and for enjoyable activities Eat a healthy diet, and keep foods on hand that are easy to prepare DIARRHEA Nearly 1 in 3 patients experience some diarrhea when taking trifluridine/tipiracil, and about 1 in 30 experiences severe diarrhea Diarrhea can be defined as the occurrence of more than three loose/watery stools per day or an increase in number of stools per day that are usual for you * Tell your doctor/nurse right away if you have diarrhea that is severe or does not go away Your doctor/nurse may look for other reasons that you are having diarrhea They may prescribe medication to treat your diarrhea They may treat you for dehydration if you lose too much fluid

5 DIARRHEA cont. Adjust how and what you eat, for example: - Eat several small meals each day, instead of 2 or 3 large ones - Try bland foods, like bananas, rice, applesauce, and toast (also known as the BRAT diet) - Stay away from high fiber foods, spicy foods, dairy products, caffeine, and alcohol Drink at least 8 glasses of water, but stay away from hot or iced drinks Take antidiarrhea medicine as directed by your doctor/nurse NAUSEA AND/OR VOMITING Nearly half of patients experience some nausea when taking trifluridine/tipiracil, and 1 in 50 experiences severe nausea Over 1 in 4 patients experiences vomiting, and 1 in 50 experiences severe vomiting * Tell your healthcare provider right away if you have nausea, vomiting, or abdominal pain that is severe or does not go away Your doctor/nurse may prescribe medication to help reduce your nausea and vomiting The best way to prevent vomiting is by preventing nausea Eat 5 or 6 small meals a day instead of 3 big ones Avoid eat greasy/fatty, fried, sweet, acidic, or spicy foods. Avoid any food that you think tastes or smells bad Avoid drinking liquids with meals Have foods and drinks that are warm instead of hot and cool instead of cold Do not lie down right after you eat If you feel like vomiting, breathe deeply and slowly References Lee JJ, Chu E. Adherence, dosing, and managing toxicities with trifluridine/tipiracil (TAS-102). Clin Colorectal Canc. 2017;16(2): Taiho Oncology. Lonsurf Treatment Companion Accessed April 19, Trifluridine and tipiracil (prescribing information). Princeton, NJ: Taiho Oncology, Inc; White T, Larson H, Minnella A, Hochster HS. Metastatic colorectal cancer: Management with trifluridine/tipiracil. Clin J Oncol Nurs. 2017;21(2):E30-E37.