Dosage

LONSURF Dosage Calculator

Calculate your patients’ personalized dosage and create personalized dosing calendars.

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Metastatic GEJ/Gastric Cancer

Dosage Guidelines

Dosing with LONSURF1

Dosing guidelines for LONSURF® (FTD/TPI) tablets

Indicated doseage 35 mg/m2 twice daily
Active treatment days Days 1 to 5 and 8 to 12 of each 28-day treatment cycle
BSA-based caculation
  • Round up to the nearest 5 mg increment
  • Do not exceed 80mg/dosea or 160 mg/daya
Administration
  • Taken orally twice daily with food
  • No restriction on food type
Missed or vomited doses Instruct patients not to retake doses of LONSURF that have been vomited or missed, and to continue with the next scheduled dose
Handling LONSURF is a cytotoxic drug. Follow applicable special handling and displosal procedures

aBased on the trifluridine component


Two tablet strengths for personalized dosing1

LONSURF is available in 15mg and 20mg tablet strengths

Tablets shown are not actual size


Dosage Cycle

4‑week dosage cycle (28 days)1

Week 1 Twice daily for 5 days with food 2 days rest
Week 2 Twice daily for 5 days with food 2 days rest
Week 3 Rest
Week 4 Rest
  • Obtain complete blood cell counts prior to and on day 15 of each cycle1

Dosage Modifications

Delay or withhold treatment before determining whether a dose reduction is needed to manage patients’ AEs1

  • Obtain complete blood cell counts prior to and on day 15 of each cycle1

When to delay the dose:

At treatment initiation, delay the cycle start of LONSURF until1:

  • Absolute neutrophil count (ANC) is ≥1500/mm3 or febrile neutropenia is resolved
  • Platelet count ≥75,000/mm3
  • Grade 3 or 4 non-hematological AEs are resolved to Grade 0 or 1

During treatment, withhold LONSURF for1:

  • ANC <500/mm3 or febrile neutropenia
  • Platelet count <50,000/mm3
  • Grade 3 or 4 non-hematological AEs

When to reduce the dose:

After recovery, resume LONSURF after reducing the dose by 5 mg/m2/dose from the previous dose level for1:

  • Febrile neutropenia
  • Uncomplicated Grade 4 neutropenia (which has recovered to ≥1500/mm3) or thrombocytopenia (which has recovered to ≥75,000/mm3) that results in more than 1-week delay in start of next cycle
  • Non-hematologic 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

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

These are the only AEs that require a dose reduction.

In the RECOURSE trial1,2:

  • 14% of patients taking LONSURF required a dose reduction
  • The most common adverse reactions or laboratory abnormalities leading to dose reduction were neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea
  • 53% of patients treated with LONSURF had a dose delay of ≥4 days due to an AE

In the TAGS trial1,3:

  • 11% of patients required a dose reduction
  • The most common adverse events or lab abnormalities leading to dose reduction were neutropenia, anemia, febrile neutropenia, and diarrhea
  • 42% of patients treated with LONSURF had a dose delay of ≥4 days

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 three steps:

  1. Choose Height and Weight to calculate your patient's BSA by entering his/her height and weight (in metric or imperial units), 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.
  3. NOTE: This tool is only intended for use in calculating patients’ starting dosage. For directions on appropriate dose modification for AE management at cycle start
    or during a cycle, click here.

  4. Create a personalized dosage calendar for your patient
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Dosage is rounded to the nearest 5 mg.
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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.
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*Tablet strength of LONSURF is based on the trifluridine component.

Create a personalized dosage calendar for your patient

Please enter a valid treatment start date

BSA = Body Surface Area

BSA calculated using the DuBois formula3

FTD/TPI = trifluridine/tipiracil

References: 1. LONSURF [Prescribing Information]. Princeton, NJ: Taiho Oncology, Inc.; 2019. 2. 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. 3. Data on file. Taiho Oncology, Inc., Princeton, NJ.

INDICATIONS

INDICATIONS

LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild type, an anti‑EGFR therapy.

LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu‑targeted therapy.

Indications and Important Safety Information +

INDICATIONS

LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild type, an anti‑EGFR therapy.

LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu‑targeted therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe Myelosuppression: LONSURF caused severe and life‑threatening myelosuppression (Grade 3‑4) consisting of neutropenia (38%), anemia (18%), thrombocytopenia (5%), and febrile neutropenia (3%). Two patients (0.2%) died due to neutropenic infection. A total of 12% 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, absolute neutrophil count less than 500/mm3, 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 and for at least 6 months after the final dose.

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 (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 than 1.5 times ULN and any AST) 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.

Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Patients with severe renal impairment (CLcr < 30 mL/min) 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 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%), infections (27% vs 16%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%). In metastatic gastric cancer or gastroesophageal junction (GEJ), the most common adverse drug reactions, respectively were, nausea (37% vs 32%), decreased appetite (34% vs 31%), vomiting (25% vs 20%), infections (23% vs 16%) and diarrhea (23% vs 14%).

Pulmonary emboli occurred more frequently in LONSURF‑treated patients compared to placebo: (2% vs 0%) in mCRC and (3% vs 2%) in metastatic gastric cancer and GEJ.

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 mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%). In metastatic gastric cancer or GEJ, the test abnormalities, respectively, were neutropenia (66% vs 4%), anemia (63% vs 38%), and thrombocytopenia (34% vs 9%).

Please see full Prescribing Information.