b'LONSURF (trifluridine and tipiracil) is available in 2 tablet strengths12 tablet strengths for personalized dosing Four-week dosing cycle (28 days)Week 1 Twice daily for 5 days with food 2 days offWeek 2 Twice daily for 5 days with food 2 days offVA Formulary Approved With Criteria for Use 15 mg trifluridine/20 mg trifluridine/Week 3 Rest6.14 mg tipiracil tablet 8.19 mg tipiracil tabletWeek 4 RestTRICARE Approved Uniform Formulary Tablets shown are actual size.IMPORTANT SAFETY INFORMATION (contd) LONSURF is the first FDA-approved combination tablet for patients with previously treatedUSE IN SPECIFIC POPULATIONS (contd)metastatic colorectal cancer (mCRC) 1and the first and only FDA-approved oral chemotherapy forGeriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared patients with previously treated metastatic gastric or gastroesophageal junction adenocarcinoma. 1 to patients younger than 65 years: Grade 3 or 4 neutropenia (46% vs 32%), Grade 3 anemia (22% vs 16%), and Grade 3 or 4 thrombocytopenia (7% vs 4%).Hepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin greater than 3 INDICATIONS times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated withwith mild hepatic impairment.fluoropyrimidine, oxaliplatin and irinotecanbased chemotherapy, an antiVEGF biological therapy, and if RAS wildRenal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate type, an antiEGFR therapy. renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junctionimpairment (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m.2adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, ADVERSE REACTIONSa platinum, either a taxane or irinotecan, and if appropriate, HER2/neutargeted therapy. Most Common Adverse Drug Reactions in Patients Treated With LONSURF (5%): The most common adverse drug IMPORTANT SAFETY INFORMATION reactions in LONSURFtreated patients vs placebotreated patients with mCRC, respectively, were asthenia/fatigue WARNINGS AND PRECAUTIONS (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), Severe Myelosuppression: LONSURF caused severe and lifethreatening myelosuppression (Grade 34) consisting ofinfections (27% vs 16%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), neutropenia (38%), anemia (18%), thrombocytopenia (5%), and febrile neutropenia (3%). Two patients (0.2%) died dueand alopecia (7% vs 1%). In metastatic gastric cancer or gastroesophageal junction (GEJ), the most common adverse drug to neutropenic infection. A total of 12% of LONSURFtreated patients received granulocytecolony stimulating factors.reactions, respectively were, nausea (37% vs 32%), decreased appetite (34% vs 31%), vomiting (25% vs 20%), infections Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically(23% vs 16%) and diarrhea (23% vs 14%).indicated. Withhold LONSURF for febrile neutropenia, absolute neutrophil count less than 500/mm, or platelets lessPulmonary emboli occurred more frequently in LONSURFtreated patients compared to placebo: in mCRC (2% vs 0%) 3than 50,000/mm 3 . Upon recovery, resume LONSURF at a reduced dose as clinically indicated. and in metastatic gastric cancer and GEJ (3% vs 2%).EmbryoFetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnantInterstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception duringLaboratory Test Abnormalities in Patients Treated With LONSURF: The most common laboratory test abnormalities in treatment and for at least 6 months after the final dose. LONSURFtreated patients vs placebotreated patients with mCRC, respectively, were anemia (77% vs 33%), neutropenia USE IN SPECIFIC POPULATIONS (67% vs 1%), and thrombocytopenia (42% vs 8%). In metastatic gastric cancer or GEJ, the test abnormalities, respectively, Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assesswere neutropenia (66% vs 4%), anemia (63% vs 38%), and thrombocytopenia (34% vs 9%).the effects of LONSURF or its metabolites on the breastfed infant or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose. Reference: 1. LONSURF. Package insert. Taiho Oncology Inc; 2019.Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductivePlease see brief summary of Prescribing Information on adjacent pages.potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltdused under license by Taiho Oncology, Inc. Please see additional Important Safety Information on next page.TAIHO ONCOLOGY, INC. 2022 All rights reserved. 06/2022 LONPMUS1629 v1Lonsurf_VA_Sprd_Ad_7.875x10.75.indd All Pages 10/26/22 11:31 AM'