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.
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Counseling Tips

See LONSURF's dosage schedule,
and learn how to get patients started.

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Dosage Schedule

LONSURF dosing:
What you need to know

LONSURF® (trifluridine and tipiracil) tablets are available in two tablet strengths to allow for personalized dosing1:

LONSURF is available in two tablet strengths

Tablets shown are not actual size

Recommended starting dose: 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.1

  • 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 is to be taken within 1 hour after the 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

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.

To help your patients stay on track, help them
create a personalized Treatment Calendar.

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Dose delays and reductions1

When to delay the dose:

Treatment initiation

Delay cycle start of LONSURF until:

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

During treatment

Withhold LONSURF for:

  • ANC <500/mm3 or febrile neutropenia
  • Platelets <50,000/mm3
  • Grade 3 or 4 non‑hematological adverse reactions

 

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 Grade 4 adverse reaction 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.

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.

cm

Please enter a valid height

kg

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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.
BSA
m2
m2

Please enter a valid BSA (rounded to 2 decimal places)

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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mg (2x Daily)
Recommended Dosage
(rounded per PI)
mg (2x Daily)
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mg
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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 formula2

Counseling tips

How to take it


1. Explain that LONSURF is taken twice a day1

Tell patients that LONSURF is a tablet they swallow within 1 hour after eating breakfast and dinner.

NOTE: Since there are no restrictions on food type, they can eat whatever they choose.

2. Note patients' specific doses1

Remind patients that LONSURF is available in two strengths [15 mg trifluridine/6.14 mg tipiracil (white) tablet, and 20 mg trifluridine/8.19 mg tipiracil (pale red) tablet], and their prescribed dose may be comprised of both strengths.

Review what their daily doses look like.

Advise them to read their prescription labels carefully and make sure to take the appropriate number of tablets.

3. Go over LONSURF's 4‑week cycle

Make note of patients' start dates, as well as the days where they will not take LONSURF. For patients who do not start on a Monday, this will be especially important.

If your patient has a Starter Kit, you can use the Treatment Calendar provided to review the dosage schedule; if not, you can find out how to order one here or talk to your Taiho representative for more information. You can also download a printable Treatment Calendar here.

Encourage your patients to use these simple tools to track their doses on a daily basis.

4. Review proper handling

Instruct patients to wash their hands after handling LONSURF tablets.3

Let patients know that anyone else who handles their medication should wear gloves.1

5. Advise on missed doses

If patients miss a dose, tell them not to take additional doses to make up for it and to check with their healthcare professional about how to proceed. If they take too much, they should call their doctor right away.3

6. Discuss proper storage

Tell patients not to store chemotherapy pills like LONSURF with other medications; they should keep LONSURF in its own container.

Advise patients to dispose of any unused LONSURF tablets after 30 days if stored outside of the original bottle, and instruct them on how to do so.1

What to look out for

Let patients know that LONSURF may cause side effects such as nausea, vomiting and diarrhea1

  • Review tips on managing side effects, and tell patients that they can find these tips at LONSURF.com
  • Schedule a follow‑up appointment, and advise patients about side effect experiences that warrant a call to their healthcare provider before their appointment date (i.e., severe or persistent nausea, vomiting, diarrhea, or abdominal pain)1
  • Stress the importance of recording and raising any concerns they have4

Discuss the potential for bone marrow suppression, neutropenia and associated fever

Tell patients that LONSURF can suppress the bone marrow, which can reduce the number of their blood cells.1 Low blood counts are common with LONSURF and can sometimes be severe and life‑threatening.3

  • Advise patients that they will need to have blood tests before they receive LONSURF, on day 15 of their treatment, and as needed to check their blood cell counts3
  • Let patients know that a reduction in white blood cells can make them more likely to get serious infections that can be fatal.3 Since fever is often the first sign of infection, encourage them to check and record their temperature each day on the printed calendar you have provided, or in the calendar included with their Starter Kit5
  • Review other signs of infection with your patients, and advise them to call their healthcare provider right away if they develop fever, chills or body aches during their treatment3
  • NOTE: You can also take this time to emphasize the importance of taking LONSURF within 1 hour after morning and evening meals, as this may help lessen its effect on their white blood cell count1

What else to keep in mind

Review pregnancy and nursing precautions

  • Advise patients of the potential risks to the fetus and to avoid pregnancy by using effective birth control during treatment with LONSURF. Males should use a condom during sex with female partners who can become pregnant during their treatment and for 3 months after their last dose. This is because LONSURF can harm their unborn baby3
  • If patients or their female partners become pregnant during this time, instruct them to tell their healthcare provider right away3
  • Since it's not known whether LONSURF passes into breast milk, advise patients not to breast‑feed during treatment with LONSURF and for 1 day after their last dose3

Discuss the potential consequences of low blood cell counts

  • Tell patients that if they develop a low white blood cell count or a low platelet count, their dose of LONSURF may need to be lowered or stopped3
Encourage all patients to read the Patient Information.1

References: 1. LONSURF [Prescribing Information]. Princeton, NJ: Taiho Oncology, Inc.; 03/2017. 2. Data on file. Taiho Oncology, Inc., Princeton, NJ. 3. LONSURF [Patient Information]. Princeton, NJ: Taiho Oncology, Inc.; 2015. 4. Denlinger C and Barsevick A. The Challenges of Colorectal Cancer Survivorship. J Natl Compr Canc Netw. 2009; 7(8): 883–894. 5. American Cancer Society. Infections in People with Cancer. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/002871-pdf.pdf. Accessed June 2, 2015.

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.