Doctor Discussion Guide

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Transcription:

Talking to your healthcare provider about LONSURF (trifluridine and tipiracil) tablets If you have colon or rectal cancer that has spread to other parts of your body and have previously been treated with or cannot receive certain chemotherapy medicines, LONSURF might be another treatment option. Your doctor or nurse can help you find out whether LONSURF is right for you. Be sure to bring this guide to your next appointment, and use the questions on the following pages to help start the conversation. Look over the following options, and check the treatment(s) you have already received: Fluoropyrimidine - such as 5-fluorouracil, also known as 5-FU Oxaliplatin-based treatment - such as FOLFOX (5 FU, leucovorin, and oxaliplatin); CAPOX (capecitabine and oxaliplatin); or Eloxatin (oxaliplatin) Irinotecan-based treatment - such as FOLFIRI (5-FU, leucovorin, and irinotecan); CAPIRI (capecitabine and irinotecan); or Camptosar (irinotecan) Anti-VEGF biological therapy, or VEGF inhibitors - such as Avastin (bevacizumab); or Zaltrap (ziv-aflibercept) Anti-EGFR therapy, or EGFR inhibitors (if you have the KRAS wild type gene) - such as Erbitux (cetuximab); or Vectibix (panitumumab) I m not sure which treatments I ve had Registered trademarks are the property of their respective owners. In a clinical trial, LONSURF was shown to be effective in patients who had already taken some or all of the treatments mentioned above. The most common side effects with LONSURF include tiredness, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever. However, for most patients in the trial, these side effects did not cause them to stop taking LONSURF (3.6% of patients taking LONSURF stopped vs 1.5% of patients taking placebo).

Additional questions to ask: 1. Based on the treatments I have previously taken, could LONSURF be right for me? 2. How can LONSURF help? 3. How does LONSURF work? 4. How and where do I take LONSURF? 5. What is the dosage schedule?

6. What would my dose be? 7. How often will I need to come in to the office with this treatment? 8. What happens if I miss a dose? 9. When should I call you if I m having signs and symptoms of side effects? 10. How can I help manage any side effects I may have? 11. How will my treatment affect my daily activities or my ability to work?

12. Does Taiho Oncology offer any financial assistance programs?

INDICATION LONSURF (trifluridine and tipiracil) tablets are a prescription medicine used to treat people with colon or rectal cancer that has spread to other parts of the body and who have been previously treated with or cannot receive certain chemotherapy medicines. It is not known if LONSURF is safe and effective in children. IMPORTANT SAFETY INFORMATION LONSURF may cause serious side effects, including: Low blood counts. Low blood counts are common with LONSURF and can sometimes be severe and life threatening. LONSURF can cause a decrease in your white blood cells, red blood cells, and platelets. Low white blood cells can make you more likely to get serious infections that could lead to death. Your healthcare provider should do blood tests before you receive LONSURF, at day 15 during treatment with LONSURF, and as needed to check your blood cell counts. Your healthcare provider may lower your dose of LONSURF or stop LONSURF if you have low white blood cell or platelet counts Tell your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with LONSURF: fever, chills, or body aches. Before taking LONSURF, tell your healthcare provider about all of your medical conditions, including if you: Have kidney or liver problems Are pregnant or plan to become pregnant. LONSURF can harm your unborn baby Females who can become pregnant should use effective birth control during treatment with LONSURF. Tell your healthcare provider immediately if you become pregnant Males, while on treatment and for 3 months after your last dose of LONSURF, you should use a condom during sex with female partners who are able to become pregnant. Tell your healthcare provider right away if your partner becomes pregnant while you are taking LONSURF Are breast feeding or plan to breast feed. It is not known if LONSURF passes into your breast milk. Do not breast feed during treatment with LONSURF and for 1 day after your last dose of LONSURF Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. The most common side effects with LONSURF include tiredness, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever. Tell your doctor if you have nausea, vomiting, or diarrhea that is severe or that does not go away. These are not all of the possible side effects of LONSURF. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects. Please see the full Prescribing Information at LONSURF.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1 800 FDA 1088.