Loading…
LONSURF is a brand name for Trifluridine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lonsurf® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based…
Verbatim from this product's HC label. Tap a section to expand.
3) 10-2020 WARNINGS AND PRECAUTIONS (6), Renal 10-2020 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................... 2 TABLE OF CONTENTS .................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................... 4 1 INDICATIONS ..................................................................................................... 1 Pediatrics ....................................................................................................
2 Geriatrics .................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................... 4 3 DOSAGE AND ADMINISTRATION ....................................................................
1 Dosing Considerations................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................... 3 Administration .............................................................................................
4 Missed Dose ............................................................................................... 9 4 OVERDOSAGE ................................................................................................... 9
1 Adverse Reaction Overview A total of 761 patients were exposed with Lonsurf at the recommended dose in patients with metastatic colorectal cancer in RECOURSE and 335 patients with metastatic gastric cancer in TAGS studies. The most common TEAE or laboratory abnormalities (≥10%) were anemia, neutropenia, fatigue/asthenia, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, and pyrexia.
Colorectal Cancer A total of 761 colorectal cancer patients who were administered Lonsurf at a dose of 35mg/m2 BID. The most serious observed treatment emergent adverse events (TEAEs) in patients receiving Lonsurf were bone marrow suppression and gastrointestinal toxicity.
9% (106/761) and leukopenia 282/761 (37%) grade ≥ 3 114/761 (15%). 6% (431/761) of patients had TEAEs leading to study treatment interruption, delay or dose reduction. 6% (20/761) of Lonsurf patients reported TEAEs with fatal outcomes.
The most common TEAEs in patients receiving Lonsurf that resulted in treatment discontinuation, dose reduction, dose delay, or dose interruption were neutropenia, general deterioration of health, anemia, febrile neutropenia, fatigue, diarrhea and dyspnoea.
Gastric Cancer A total of 335 patients with gastric or GEJ adenocarcinoma received Lonsurf and Best Supportive Care (BSC) and 168 patients in placebo arm received BSC only. Lonsurf 35 mg/m2/dose was administrated twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle with best supportive care.
9% (23/335). In TAGS, 11% (37/335) of patients receiving Lonsurf required a dose reduction. The most common TEAEs or laboratory abnormalities leading to dose reduction were neutropenia, anemia, febrile neutropenia, pancytopenia, neutrophil count decrease, diarrhea and nausea.
Patients treated with Lonsurf having events leading to delay of 4 days was reported in 42% (322/773 total cycles) and delay of 8 days in 14% (105/773 total cycles). In TAGS, 13% (43/335) of patients discontinued Lonsurf for a TEAE and 17% (28/168) patients in the placebo group.
3) 10-2020 WARNINGS AND PRECAUTIONS (6), Renal 10-2020 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................... 2 TABLE OF CONTENTS .................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................... 4 1 INDICATIONS ..................................................................................................... 1 Pediatrics ....................................................................................................
2 Geriatrics .................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................... 4 3 DOSAGE AND ADMINISTRATION ....................................................................
1 Dosing Considerations................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................... 3 Administration .............................................................................................
4 Missed Dose ............................................................................................... 9 4 OVERDOSAGE ................................................................................................... 9 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..........
10 6 WARNINGS AND PRECAUTIONS ................................................................... 1 Special Populations .................................................................................. 1 Pregnant Women ..................................................................................
2 Breast-feeding ....................................................................................... 3 Pediatrics .............................................................................................. 4 Geriatrics ...............................................................................................
Lonsurf is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, or component of the container closure. For a complete listing (see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Page 5 of 42
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Trifluridine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Four (4)% (14/335) of Lonsurf patients reported adverse events with fatal outcomes. 03), respectively, observed in TAGS. Four (4)% (14/335) of Lonsurf patients reported adverse events with fatal outcomes. Safety results seen in patients with gastric cancer, including Grade ≥ 3 TEAEs, were similar to those in patients with metastatic colorectal cancer.
No new safety signals were seen in patients with metastatic gastric cancer. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Page 16 of 42 Colorectal Cancer The data described below are from RECOURSE, a randomised (2:1), double-blind, placebo-controlled trial in which 533 patients (median age 63 years; 61% men; 57% White, 35% Asian, 1% Black) with previously treated metastatic colorectal cancer received Lonsurf as a single agent at a dose of 35 mg/m2/dose administered twice daily on Days 1 through 5 and Days 8 through 12 of each 28-day cycle.
7 weeks. The most frequently observed TEAEs or laboratory abnormalities (all Grades and ≥10% in incidence) in Lonsurf treated patients at a rate that exceeds the rate in patients receiving placebo were anemia, neutropenia, fatigue/asthenia, nausea, thrombocytopenia, decreased appetite, diarrhoea, vomiting, pyrexia, and abdominal pain.
6%) patients in the placebo group. 6%). 1%). 7% of patients in the Lonsurf group. TEAEs leading to dose reduction were reported for 72 of these patients. 3%). 1%) patients had a single dose reduction, with 2 reporting TEAEs leading to dose reduction (1, anemia; 1, bronchopneumonia).
Table 6 Very Common (≥ 10 %) and Common (≥ 1% and < 10%) Treatment Emergent Adverse Events Reported in Patients […]
5 Renal ..................................................................................................... 14 7 ADVERSE REACTIONS ................................................................................... 1 Adverse Reaction Overview .....................................................................
2 Clinical Trial Adverse Reactions ............................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................... 4 Abnormal Hematologic Laboratory Findings .............................................
5 Post-Market Adverse Reactions ............................................................... 20 8 DRUG INTERACTIONS .................................................................................... 1 Overview...................................................................................................
2 Drug-Drug Interactions ............................................................................. 3 Drug-Food Interactions ............................................................................. 4 Drug-Herb Interactions .............................................................................
5 Drug-Laboratory Test Interactions ............................................................ 21 Page 3 of 42 9 ACTION AND CLINICAL PHARMACOLOGY .................................................. 1 Mechanism of Action ................................................................................
2 Pharmacodynamics .................................................................................. 3 Pharmacokinetics ..................................................................................... 22 10 STORAGE, STABILITY AND DISPOSAL ........................................................
25 PART II: SCIENTIFIC INFORMATION ........................................................................ 27 11 PHARMACEUTICAL INFORMATION .............................................................. 27 12 CLINICAL TRIALS ............................................................................................
1 Trial Design and Study Demographics .................................................. 2 Study Results ........................................................................................ 31 13 NON-CLINICAL TOXICOLOGY ........................................................................
37 PATIENT MEDICATION INFORMATION .................................................................... 38 Page 4 of 42 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Lonsurf® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.
Lonsurf monotherapy is indicated for the treatment of adult patients with metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.
Clinical effectiveness of Lonsurf is based on benefit observed in a pivotal study in patients who had been previously treated with all of the above available therapies. 1 Pediatrics Pediatrics (0 – 18 years): No pediatric data have been made available to Health Canada; therefore, […]