INDICATION: LONSURF is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) 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.
INDICATION: LONSURF is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) 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.

Dosage

Oral dosing within 1 hour of meals, with no restriction on food type1

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Efficacy & Safety

Dosage Guidelines1

The recommended starting dose of LONSURF® (trifluridine and tipiracil) tablets is 35 mg/m2 administered orally twice daily on days 1 through 5 and days 8 through 12 of each 28‑day cycle until disease progression or unacceptable toxicity.

  • Round dose up to the nearest 5‑mg increment. Do not exceed 80 mg/dose or 160 mg/day (based on the trifluridine component)
  • LONSURF should be taken within 1 hour after completion of morning and evening meals
    • -Based on the pharmacokinetics of LONSURF, administration within 1 hour after meals is recommended to lessen the negative effect on neutrophil counts
  • There is no restriction on food type
  • If doses were missed or held, the patient should not make up for the missed doses
  • LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures

Two tablet strengths for personalized dosing1

LONSURF is available in two tablet strengths

Tablets shown are not actual size


Dosage Cycle

4‑week dosage cycle (28 days)1

LONSURF dosing cycle LONSURF dosing cycle
  • Obtain complete blood cell counts prior to and on day 15 of each cycle.

Appropriate Dose Modifications for Adverse Event (AE) Management1

At Cycle Start
During Cycle

For AEs already present at cycle start, first delay treatment and then re‑initiate as recommended1,2

Neutropenia
  • ANC 500/mm3 to <1500/mm3
    Delay treatment until recovery: ANC is ≥1500/mm3

    Resume at same dose


  • ANC <500/mm3
    Delay treatment until recovery: ANC is ≥1500/mm3

    Recovery ≤1 week: Resume at same dose

    Recovery >1 week: Resume at 5 mg/m2/dose lower than previous dose

Febrile Neutropenia
  • ANC <1000/mm3 with 101.0°F temperature or 100.4°F >1 hour
    Delay treatment until ANC is ≥1500/mm3 and fever is resolved

    After recovery, resume at 5 mg/m2/dose lower than previous dose

Thrombocytopenia
  • Platelet count 25,000/mm3 to <75,000/mm3
    Delay treatment until platelet count is ≥75,000/mm3

    After recovery, resume at same dose


  • Platelet count <25,000/mm3
    Delay treatment until platelet count is ≥75,000/mm3

    Recovery ≤1 week: Resume at same dose

    Recovery >1 week: Resume at 5 mg/m2/dose lower than previous dose

Non‑hematologic AEs*
  • Grades 3‑4
    Delay treatment until resolved to Grade 0 or 1

    Resume at 5 mg/m2/dose lower than previous dose

*For all Grade 3 or 4 AEs except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication.1
AE=adverse event; ANC=absolute neutrophil count

For AEs occurring during active treatment,* first withhold treatment and then re‑initiate as recommended1,2

Neutropenia
  • ANC <500/mm3
    Withhold treatment until recovery: ANC is ≥1500/mm3

    Recovery ≤1 week: Resume at same dose

    Recovery >1 week: Resume at 5 mg/m2/dose lower than previous dose

Febrile Neutropenia
  • ANC <1000/mm3 with 101.0°F temperature or 100.4°F >1 hour
    Withhold treatment until ANC is ≥1500/mm3 and fever is resolved

    After recovery, resume at 5 mg/m2/dose lower than previous dose

Thrombocytopenia
  • Platelet count 25,000/mm3 to <50,000/mm3
    Withhold treatment until platelet count is ≥75,000/mm3

    After recovery, resume at same dose


  • Platelet count <25,000/mm3
    Withhold treatment until platelet count is ≥75,000/mm3

    Recovery ≤1 week: Resume at same dose

    Recovery >1 week: Resume at 5 mg/m2/dose lower than previous dose

Non‑hematologic AEs
  • Grades 3‑4
    Delay treatment until resolved to Grade 0 or 1

    Resume at 5 mg/m2/dose lower than previous dose

*Active treatment occurs on days 1 through 5 and days 8 through 12 of each 28‑day cycle.1
For all Grade 3 or 4 AEs except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication.1
AE=adverse event; ANC=absolute neutrophil count

At Cycle Start

For AEs already present at cycle start, FIRST DELAY treatment and then re-initiate as recommended1,2

Neutropenia
Febrile Neutropenia
Thrombocytopenia
Non‑hematologic AEs*

*For all Grade 3 or 4 AEs except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication.1
AE=adverse event; ANC=absolute neutrophil count

Obtain complete blood cell counts prior to and on day 15 of each cycle. A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily. Do not escalate LONSURF dose after it has been reduced.1


In the RECOURSE trial3:

  • 53% of patients treated with LONSURF had a dose delay of ≥4 days due to an AE
  • 86% of patients taking LONSURF did not require a dose reduction

RECOURSE=Refractory Colorectal Cancer Study (Study 1)3


During Cycle

For AEs occurring during active treatment,* FIRST WITHHOLD treatment and then re-initiate as recommended1,2

Neutropenia
Febrile Neutropenia
Thrombocytopenia
Non‑hematologic AEs*

*Active treatment occurs on days 1 through 5 and days 8 through 12 of each 28‑day cycle.1
For all Grade 3 or 4 AEs except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication.1
AE=adverse event; ANC=absolute neutrophil count

Obtain complete blood cell counts prior to and on day 15 of each cycle. A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily. Do not escalate LONSURF dose after it has been reduced.1


In the RECOURSE trial3:

  • 53% of patients treated with LONSURF had a dose delay of ≥4 days due to an AE
  • 86% of patients taking LONSURF did not require a dose reduction

RECOURSE=Refractory Colorectal Cancer Study (Study 1)3

Dosage Calculator

Calculate your patients' recommended LONSURF starting dosage

Start new LONSURF patients with the recommended dosage using the Dosage Calculator below. To calculate a patient's personalized dosage, follow these two steps:

  1. Choose Height and Weight to calculate your patient's BSA by entering his/her height (cm) and weight (kg), or BSA to enter his/her BSA (m2) directly
  2. Select "Calculate Dosage"

The tablets comprising the recommended morning and evening doses (rounded up to the nearest 5 mg increment) will be displayed.

NOTE: This tool is only intended for use in calculating patients' starting dosage. For directions on appropriate dose modification for adverse event management at cycle start or during a cycle, click here.

Download the LONSURF
Dosage Calculator App

Calculate your patients'
personalized dosages
right on your smartphone.

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Dosage is rounded to the nearest 5 mg.
Minimum dose is 35 mg twice daily.
Maximum dose is 80 mg twice daily.
BSA
m2
m2

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Please calculate dosage

Dosage is rounded to the nearest 5 mg.
Minimum dose is 35 mg twice daily.
Maximum dose is 80 mg twice daily.
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(per formula)
mg (2x Daily)
Recommended Dosage
(rounded per PI)
mg (2x Daily)
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Pill Count

Morning
Evening

*Tablet strength of LONSURF is based on 1 active part of the medicine.

Create a personalized dosage calendar for your patient

Please enter a valid treatment start date

BSA = Body Surface Area

BSA calculated using the DuBois formula4

References: 1. LONSURF [Prescribing Information]. Princeton, NJ: Taiho Oncology, Inc.; 03/2017. 2. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). v4.03. US Dept of Health and Human Services; 2010. 3. Mayer RJ, Van Cutsem E, Falcone A, et al; for the RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015; 372(20):1909‑1919. 4. Data on file. Taiho Oncology, Inc., Princeton, NJ.

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 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%).

Please see full Prescribing Information.