WARNINGS AND PRECAUTIONS

Transcription

1 Pursue more moments LONSURF (trifluridine and tipiracil) is 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. In a clinical trial of 800 patients, half of the patients treated with LONSURF were still alive at 7.1 months and half of the patients who received placebo were still alive at 5.3 months. Worsening of the disease or death occurred in 88% of patients treated with LONSURF and 94% of patients who received placebo. Selected Important Safety Information Low blood counts. LONSURF can decrease the number of your blood cells. This can sometimes be severe and life-threatening. Please see Important Safety Information on back of tear sheet and full Prescribing Information in pocket.

2 Notes Please see Important Safety Information on back and full Prescribing Information in pocket.

3 SAMPLE PAGE Arlene Myers LONSURF 28-Day Dosing Schedule for LONSURF (trifluridine and tipiracil) comes in 2 strengths. Your healthcare provider may prescribe both strengths for your prescribed dose. Morning dose: 0 15-mg tablets* 3 20-mg tablets* Evening dose: 0 15-mg tablets 3 20-mg tablets Tablets shown are not actual size. Day 1: Thurs, 4/7 Day 8: Thurs, 4/14 Day 2: Fri, 4/8 Day 9: Day 3: Sat, 4/9 Day 10: Day 4: Sun, 4/10 Day 11: Sun, 4/17 Day 5: Mon, 4/11 Day 12: Mon, 4/18 Day 6: REST Tues, 4/12 Day 13: REST Tues, 4/19 Day 7: REST Wed, 4/13 Day 14: REST Fri, 4/15 Sat, 4/16 Wed, 4/20 Day 15: REST Day 16: REST Day 17: REST Day 18: REST Day 19: REST Day 20: REST Day 21: REST Day 22: REST Day 23: REST Day 24: REST Day 25: REST Day 26: REST Day 27: REST Day 28: REST LONSURF is a tablet you swallow: Twice a day after morning and evening meals (immediately after or up to 1 hour after) The type of food does not matter You may have side effects when taking LONSURF. Always discuss any side effects with your healthcare provider, especially if you have nausea, vomiting, or diarrhea that is severe or that does not go away. You may report side effects to the FDA at FDA For questions about financial support or treatment with LONSURF, call TAIHO-4U ( ) or go to TaihoPatientSupport.com. Learn more at LONSURF.com/dosing *Tablet strength of LONSURF is based on 1 active part of the medicine. Please see Important Safety Information on back and ask your healthcare provider for the full Prescribing Information.

4 Important Safety Information LONSURF (trifluridine and tipiracil) 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 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 ask your healthcare provider for the full Prescribing Information. LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltd., used under license by Taiho Oncology, Inc. TAIHO ONCOLOGY, INC. 02/2016 All rights reserved. LON-PM-US-0047 v2

5 LONSURF 28-Day Dosing Schedule for LONSURF (trifluridine and tipiracil) comes in 2 strengths. Your healthcare provider may prescribe both strengths for your prescribed dose. Morning dose: 15-mg tablets* 20-mg tablets* Evening dose: 15-mg tablets 20-mg tablets Tablets shown are not actual size. Day 1: Day 2: Day 3: Day 4: Day 5: Day 6: REST Day 7: REST Day 8: Day 9: Day 10: Day 11: Day 12: Day 13: REST Day 14: REST Day 15: REST Day 16: REST Day 17: REST Day 18: REST Day 19: REST Day 20: REST Day 21: REST Day 22: REST Day 23: REST Day 24: REST Day 25: REST Day 26: REST Day 27: REST Day 28: REST LONSURF is a tablet you swallow: Twice a day after morning and evening meals (immediately after or up to 1 hour after) The type of food does not matter You may have side effects when taking LONSURF. Always discuss any side effects with your healthcare provider, especially if you have nausea, vomiting, or diarrhea that is severe or that does not go away. You may report side effects to the FDA at FDA For questions about financial support or treatment with LONSURF, call TAIHO-4U ( ) or go to TaihoPatientSupport.com. Learn more at LONSURF.com/dosing *Tablet strength of LONSURF is based on 1 active part of the medicine. Please see Important Safety Information on back and ask your healthcare provider for the full Prescribing Information.

6 Important Safety Information LONSURF (trifluridine and tipiracil) 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 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 ask your healthcare provider for the full Prescribing Information. LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltd., used under license by Taiho Oncology, Inc. TAIHO ONCOLOGY, INC. 02/2016 All rights reserved. LON-PM-US-0047 v2

7 Indication LONSURF (trifluridine and tipiracil) is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf biological therapy, and if RAS wild type, an anti-egfr therapy. Important Safety Information WARNINGS AND PRECAUTIONS Severe Myelosuppression: In Study 1, LONSURF caused severe and life-threatening myelosuppression (Grade 3-4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF-treated patients received granulocyte-colony stimulating factors. Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose. Embryo-Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF. USE IN SPECIFIC POPULATIONS Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast-fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast-fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose. Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose. Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anemia (26% vs 12%), and Grade 3 or 4 thrombocytopenia (9% vs 2%). Renal Impairment: In Study 1, patients with moderate renal impairment (CLcr=30 to 59 ml/min, n=47) had a higher incidence (difference of at least 5%) of Grade 3 adverse events, serious adverse events, and dose delays and reductions compared to patients with normal renal function (CLcr 90 ml/min, n=306) or patients with mild renal impairment (CLcr=60 to 89 ml/min, n=178). Patients with moderate renal impairment may require dose modifications for increased toxicity. No patients with severe renal impairment were enrolled in Study 1. ADVERSE REACTIONS Most Common Adverse Drug Reactions in Patients Treated With LONSURF ( 5%): The most common adverse drug reactions in LONSURF-treated patients vs placebo-treated patients with refractory mcrc, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%). Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURFtreated patients compared to placebo: infections (27% vs 15%) and pulmonary emboli (2% vs 0%). The most commonly reported infections which occurred more frequently in LONSURF-treated patients were nasopharyngitis (4% vs 2%) and urinary tract infections (4% vs 2%). Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia. Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF-treated patients vs placebo-treated patients with refractory mcrc, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%). Please see full Prescribing Information in pocket. LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltd., used under license by Taiho Oncology, Inc. TAIHO ONCOLOGY, INC. 02/2016 All rights reserved. LON-PM-US-0047 v2