Lonsurf

Last reviewed on RxList: 4/21/2020
Lonsurf Side Effects Center

What Is Lonsurf?

Lonsurf (trifluridine and tipiracil) is a combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor 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.

What Are Side Effects of Lonsurf?

Common side effects of Lonsurf include:

Serious side effects of Lonsurf include blood clots in the lungs (pulmonary emboli).

Dosage for Lonsurf

The recommended dose of Lonsurf is 35 mg/m2/dose orally twice daily on days 1 through 5 and days 8 through 12 of each 28-day cycle.

What Drugs, Substances, or Supplements Interact with Lonsurf?

Lonsurf may interact with other drugs. Tell your doctor all medications and supplements you use.

Lonsurf During Pregnancy and Breastfeeding

Lonsurf is not recommended for use during pregnancy; it may harm a fetus. Talk to your doctor about using effective birth control while taking Lonsurf. Lonsurf is not recommended for use while breastfeeding.

Additional Information

Our Lonsurf (trifluridine and tipiracil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What are risk factors for developing colon cancer? See Answer
Lonsurf Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • low levels of platelets in your blood--easy bruising, unusual bleeding, purple or red spots under your skin;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Serious side effects may be more likely in older adults.

Common side effects may include:

  • stomach pain, loss of appetite;
  • nausea, vomiting, diarrhea;
  • fever; or
  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lonsurf (Trifluridine and Tipiracil Tablets)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Lonsurf Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Severe Myelosuppression [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the WARNINGS AND PRECAUTIONS section and below reflect exposure to LONSURF at the recommended dose in 533 patients with metastatic colorectal cancer in RECOURSE and 335 patients with metastatic gastric cancer in TAGS. Among the 868 patients who received LONSURF, 11% were exposed for 6 months or longer and 1% were exposed for 12 months or longer. The most common adverse reactions or laboratory abnormalities . are anemia, neutropenia, fatigue/asthenia, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, and pyrexia.

Metastatic Colorectal Cancer

The safety of LONSURF was evaluated in RECOURSE, a randomized (2:1), double-blind, placebo-controlled trial in patients with previously treated metastatic colorectal cancer [see Clinical Studies]. Patients received LONSURF 35 mg/m²/dose (n=533) or placebo (n=265) twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. In RECOURSE, 12% of patients received LONSURF for more than 6 months and 1% of patients received LONSURF for more than 1 year.

The study population characteristics were: median age 63 years; 61% male; 57% White, 35% Asian, and 1% Black.

The most common adverse reactions or laboratory abnormalities (.10% in incidence) in patients treated with LONSURF at a rate that exceeds the rate in patients receiving placebo were anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia.

In RECOURSE, 3.6% of patients discontinued LONSURF for an adverse reaction and 14% of patients required a dose reduction. The most common adverse reactions or laboratory abnormalities leading to dose reduction were neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea.

Tables 3 and 4 list the adverse reactions and laboratory abnormalities (graded using CTCAE v4.03), respectively, observed in RECOURSE.

Table 3 : Adverse Reactions (≥%) in Patients Receiving LONSURF and at a Higher Incidence (>2%) than in Patients Receiving Placebo in RECOURSE

Adverse ReactionsLONSURF
(N=533)
Placebo
(N=265)
All Grades (%)Grades 3-4* (%)All Grades (%)Grades 3-4* (%)
General
Asthenia/fatigue527359
Pyrexia19114<1
Gastrointestinal
Nausea482241
Diarrhea32312<1
Vomiting28214<1
Abdominal pain212184
Stomatitis8<160
Metabolism and nutrition
Decreased appetite394295
Infections†276165
Nervous system
Dysgeusia7020
Skin and subcutaneous tissue
Alopecia7010
*No Grade 4 definition for nausea, abdominal pain, or fatigue in National Cancer Institute Common Terminology
†Incidence reflects 64 preferred terms in the Infections and Infestations system organ class.

Table 4 : Laboratory Abnormalities in RECOURSE

Laboratory Parameter*LONSURFPlacebo
All Grades (%)Grades 3-4 (%)All Grades (%)Grades 3-4 (%)
Hematologic
Anemia†7718333
Neutropenia673810
Thrombocytopenia4258<1
* Worst Grade at least one grade higher than baseline, with percentages based on number of patients with post-baseline samples, which may be <533 (LONSURF) or 265 (placebo)
† One Grade 4 anemia adverse reaction based on clinical criteria was reported

In RECOURSE, pulmonary emboli occurred more frequently in LONSURF-treated patients (2%) compared to no patients on placebo.

Metastatic Gastric Cancer

The safety of LONSURF was evaluated in TAGS, an international, randomized (2:1), double-blind, placebo-controlled trial in patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who were previously treated with at least 2 prior chemotherapy regimens for advanced disease [see Clinical Studies]. Previous treatments must have included a fluoropyrimidine, a platinum, and either a taxane or irinotecan. Patients with HER2/neu-positive tumors must have received prior HER2/neu-targeted therapy, if available. Adjuvant chemotherapy could be counted as one prior regimen in patients who had recurrence during or within 6 months of completion of the adjuvant chemotherapy. Patients received LONSURF 35 mg/m²/dose (n=335) or placebo (n=168) twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle with best supportive care. In TAGS, 10% of patients received LONSURF for more than 6 months and 0.9% of patients received LONSURF for more than 1 year.

The study population characteristics were: median age 63 years (24 to 89 years); 73% male; 70% White, 16% Asian, and 1% Black.

The most common adverse reactions or laboratory abnormalitiles (≥10 in incidence ) in patients treated with LONSURF at a rate that exceeds the rate in patients receiving placebo were neutropenia, anemia, nausea, decreased appetite, thrombocytopenia, vomiting, and diarrhea.

In TAGS, 13% of patients discontinued LONSURF for an adverse reaction and 11% of patients required a dose reduction. The most common adverse reactions or laboratory abnormalities leading to dose reduction were neutropenia, anemia, febrile neutropenia, and diarrhea.

Tables 5 and 6 list the adverse reactions and laboratory abnormalities (graded using CTCAE v4.03), respectively, observed in TAGS.

Table 5 : Adverse Reactions(≥5%) in Patients Receiving LONSURF and at a Higher Incidence (>2%) than in Patients Receiving Placebo in TAGS

Adverse ReactionsLONSURF
(N=335)
Placebo
(N=168)
All Grades (%)Grades 3-4* (%)All Grades (%)Grades 3-4* (%)
Gastrointestinal
Nausea373323
Vomiting254202
Diarrhea233142
Metabolism and nutrition
Decreased appetite349317
Infections†235165
*No Grade 4 definition for nausea or fatigue in NCI CTCAE, version 4.03.
†Incidence reflects 46 preferred terms in the Infections and Infestations system organ class.

Table 6 : Laboratory Abnormalities in TAGS

Laboratory ParameterLONSURFPlacebo
All Grades (%)Grades 3-4 (%)All Grades (%)Grades 3-4 (%)
Hematologic
Neutropenia663840
Anemia†6319387
Thrombocytopenia34690
* Worst Grade at least one Grade higher than baseline, with percent based on number of patients with post-baseline samples which may be <335 (LONSURF) or 168 (placebo)
† Anemia: No Grade 4 definition in CTCAE, v4.03

In TAGS, pulmonary emboli occurred more frequently in LONSURF-treated patients (3.1%) compared to 1.8% for patients on placebo.

Additional Clinical Experience

Interstitial lung disease was reported in 15 (0.2%) patients, 3 of which were fatal, among approximately 7,000 patients exposed to LONSURF in clinical studies and clinical practice settings in Asia.

Read the entire FDA prescribing information for Lonsurf (Trifluridine and Tipiracil Tablets)

© Lonsurf Patient Information is supplied by Cerner Multum, Inc. and Lonsurf Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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