LONSURF 6.14 mg/1
trifluridine and tipiracil · TABLET, FILM COATED · Taiho Pharmaceutical Co., Ltd.
LONSURF is a tablet, film coated containing trifluridine and tipiracil at 6.14 mg/1, taken oral. Manufactured by Taiho Pharmaceutical Co., Ltd..
Key Facts
- Brand Name
- LONSURF
- Generic Name
- trifluridine and tipiracil
- NDC Code (Product)
64842-1025- Manufacturer
- Taiho Pharmaceutical Co., Ltd.
- Strength
- 6.14 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA207981
- Drug Class
- Nucleoside Analog Antiviral [EPC]; Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 09/22/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab 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. ( 1.1 ) 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. ( 1.2 ) 1.1 Metastatic Colorectal Cancer LONSURF, as a single agent or in combination with bevacizumab, 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. 1.2 Metastatic Gastric Cancer LONSURF is indicated for the treatment of adult patients with metastatic gastric or gas…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dosage : 35 mg/m 2 /dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of LONSURF as a single agent or in combination with bevacizumab is 35 mg/m 2 up to a maximum of 80 mg per dose (based on the trifluridine component) orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity. Round dose to the nearest 5 mg increment. Refer to the Prescribing Information for bevacizumab dosing information. Instruct patients to swallow LONSURF tablets whole. Instruct patients not to retake doses of LONSURF that are vomited or missed and to continue with the next scheduled dose. LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Table 1 shows the calculated initial daily dose based on body surface area (BSA). Table 1: Recommended Dosage According to Body Surface Area (BSA) BSA (m2) Total daily dose (mg) Dose (mg) administered twice daily Tablets per dose 15 mg 20 mg < 1.07 70 35 1 1 1.07 – 1.22 80 40 0 2 1.23 – 1.37 90 45 3 0 1.38 – 1.52 …
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Severe Myelosuppression [see Warnings and Precautions (5.1) ] The most common adverse reactions or laboratory abnormalities for single agent LONSURF (≥10%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. ( 6.1 ) The most common adverse reactions or laboratory abnormalities for LONSURF in combination with bevacizumab (≥20%) are neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taiho Oncology, Inc. at 1-844-878-2446 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 described in the WARNINGS AND PRECAUTIO…
Frequently Asked Questions
What is LONSURF used for?
LONSURF contains trifluridine and tipiracil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is LONSURF a controlled substance?
LONSURF is not classified as a controlled substance by the DEA.
What is the generic name for LONSURF?
The generic name for LONSURF is trifluridine and tipiracil. There are no other listed brand versions of trifluridine and tipiracil.
What is the NDC code for LONSURF 6.14 mg/1?
The NDC (National Drug Code) for LONSURF 6.14 mg/1 is 64842-1025, listed by Taiho Pharmaceutical Co., Ltd..
Other LONSURF Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)