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.
Access & Reimbursement

Resources

Here, you will find useful resources to help patients and caregivers learn more about LONSURF and reimbursement assistance, as well as tools to help them stay on track. You can download and print the brochures for use during patient visits, or email them to provide extra support at home.

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Patient Starter Kit

LONSURF Patient Starter Kit

The kit contains useful resources and tools to help your patients start and stay on LONSURF, including a:

  • Welcome Letter
  • LONSURF Treatment Companion (*Available for download below)
  • LONSURF Caregiver Brochure (*Available for download below)
  • Treatment Calendar
  • Pill Boxes
  • Thermometer

To request a Patient Starter Kit, you can:

LONSURF Patient Starter Kit

Patient and Caregiver Resources

Please select language for download

LONSURF Treatment Companion

The Treatment Companion is a comprehensive brochure that can help educate prospective and current patients on what LONSURF is, who it can help, and how it works. It also provides patients and caregivers with tips and support on how to cope with metastatic colon or rectal cancer, helpful ways to manage some of the most common side effects associated with LONSURF, and guidance on resources and treatment services provided by Taiho Oncology Patient Support, including financial assistance.

Available in English only.

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LONSURF Patient Brochure

This booklet outlines the appropriate patients who may benefit from LONSURF, how it can help, and how it is taken. It also includes practical tips on managing some of the common side effects associated with treatment, as well as guidance on accessing treatment and financial assistance. Whether patients have already been prescribed or are considering LONSURF, the Patient Brochure provides the key information they need.

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LONSURF Caregiver Brochure

This caregiver-specific brochure goes beyond a description of treatment with LONSURF, its dosage schedule, and helpful ways to manage some of the common side effects associated with the treatment. It also acknowledges the caregiver's important role by providing many practical tips on caring for their own, and their loved one's, physical and mental health. The Caregiver Brochure also provides information on accessing treatment and financial assistance, as well as answers to some frequently asked questions about LONSURF.

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Taiho Oncology Patient Assistance Brochure

This brochure includes information about the financial assistance, reimbursement, and treatment services provided by Taiho Oncology Patient Support, and how patients can enroll in the program.

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Potential Changes in Your Treatment Brochure

This helpful brochure examines the potential changes that may be made to patients' LONSURF treatment plans. The simple question and answer format addresses common concerns patients may have including why and how their treatment plan could change, and the likelihood of change occurring.

Available in English only.

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Patient Tools

Side Effect Management Tool

Located on the LONSURF Patient website, this interactive tool outlines useful tips to help patients manage some of the most common side effects associated with LONSURF.

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Personalized Treatment Calendar

Located on the LONSURF Patient website, this interactive tool allows patients to create and print their own personalized treatment calendar quickly and easily.

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Healthcare Provider Tools and Resources

Dosage Sheet

Designed for you to fill out with your patients, this customizable calendar streamlined schedule makes note of their morning and evening doses.

Available in English only.

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Dose Modification Leave Behind

This brief information leaflet lists the recommended dosing guidelines for LONSURF. Importantly, it outlines how to appropriately initiate and modify patients' doses when required to manage adverse events, both at cycle start and during active treatment.

Available in English only.

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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.

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%).

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. No patients with severe renal impairment were enrolled in Study 1.

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.