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Taiho mCRC Regional Events

LONSURF® (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer: Patient Management and Patient Education

You are invited to attend a program by Taiho Oncology, Inc., on patient management and education of LONSURF® (trifluridine and tipiracil) tablets for refractory metastatic colorectal cancer.

NOTE: Pursuant to the PhRMA Code on Interactions with Healthcare Professionals, as well as the policies of Taiho Oncology, Inc., attendance of this promotional program is restricted to healthcare professionals (HCPs) within the targeted oncology specialty. Accordingly, spouses and guests are not permitted to attend this program unless they are an HCP within the targeted oncology specialty.

 

Taiho will report information related to the event, such as your name and the value and purpose of any educational item, meal or other items of value you receive, to the extent required by federal and state laws, as applicable.  Please let us know if you are licensed in any state or other jurisdiction, or are an employee or contractor of any organization or government entity that limits or prohibits meals from pharmaceutical companies.  HCPs may attend the program and decline a meal.  Please note this with your registration and designate this at the venue as you sign-in for the program.

Indication

LONSURF 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.

Selected Important Safety Information

Severe Myelosuppression: LONSURF caused severe and life-threatening myelosuppression (Grade 3-4). Obtain complete blood counts prior to initiation and on day 15 of each treatment cycle and monitor for signs of infection. Increase frequency of blood counts, adjust dosage, and/or withhold LONSURF as clinically indicated.

 

Thursday, November 30, 2017

Boise, ID - Southern Idaho

Ruth's Chris Steak House
800 West Main Street  #110
Boise, ID 83702

Megan Price, APRN, MSN, FNP-C

REGISTER HERE

Program Registration: 6 PM
Program Start: 6:30 PM
Thursday, November 30, 2017

Albuquerque

Ruth's Chris Steak House
6640 Indian School Road NE
Albuquerque, NM  87110

Megan Price, APRN, MSN, FNP-C

REGISTER HERE

Program Registration: 6 PM
Program Start: 6:30 PM
Thursday, November 30, 2017

Tulsa, OK - Northeast Oklahoma

Mahogany Prime Steakhouse
6823 South Yale Avenue
Tulsa, Oklahoma, 74136

Megan Price, APRN, MSN, FNP-C

REGISTER HERE

Program Registration: 6 PM
Program Start: 6:30 PM
Thursday, November 30, 2017

Intermountain - Salt Lake City

Ruth's Chris Steak House
275 South West Temple
Salt Lake City, UT 84101

Megan Price, APRN, MSN, FNP-C

REGISTER HERE

Program Registration: 6 PM
Program Start: 6:30 PM

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 as clinically indicated.

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%).

Hepatic Impairment: Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment. Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment.

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. Patients with severe renal impairment were not studied.

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 LONSURF‑treated 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%).

Click here for full Prescribing Information

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© TAIHO ONCOLOGY, INC.  03/2017  All rights reserved. LON-PM-US-0896

Lonsurf is a registered trademark of Taiho Pharmaceutical Co. Ltd. used under license by Taiho Oncology, Inc.