Trifluridine and tipiracil
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Allison Tu [2]
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Overview
Trifluridine and tipiracil is a combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor that is FDA approved 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. Common adverse reactions include fatigue, nausea, diarrhea, decreased appetite, abdominal pain, anemia, neutropenia, thrombocytopenia, weakness, and fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Trifluridine and tipiracil FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trifluridine and tipiracil in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trifluridine and tipiracil in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Trifluridine and tipiracil FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trifluridine and tipiracil in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trifluridine and tipiracil in pediatric patients.
Contraindications
There is limited information regarding Trifluridine and tipiracil Contraindications in the drug label.
Warnings
There is limited information regarding Trifluridine and tipiracil Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Trifluridine and tipiracil Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Trifluridine and tipiracil Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Trifluridine and tipiracil Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Trifluridine and tipiracil in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trifluridine and tipiracil in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Trifluridine and tipiracil during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Trifluridine and tipiracil in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Trifluridine and tipiracil in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Trifluridine and tipiracil in geriatric settings.
Gender
There is no FDA guidance on the use of Trifluridine and tipiracil with respect to specific gender populations.
Race
There is no FDA guidance on the use of Trifluridine and tipiracil with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Trifluridine and tipiracil in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Trifluridine and tipiracil in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trifluridine and tipiracil in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Trifluridine and tipiracil in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Trifluridine and tipiracil Administration in the drug label.
Monitoring
There is limited information regarding Trifluridine and tipiracil Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Trifluridine and tipiracil and IV administrations.
Overdosage
There is limited information regarding Trifluridine and tipiracil overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Trifluridine and tipiracil Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Trifluridine and tipiracil Mechanism of Action in the drug label.
Structure
There is limited information regarding Trifluridine and tipiracil Structure in the drug label.
Pharmacodynamics
There is limited information regarding Trifluridine and tipiracil Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Trifluridine and tipiracil Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Trifluridine and tipiracil Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Trifluridine and tipiracil Clinical Studies in the drug label.
How Supplied
There is limited information regarding Trifluridine and tipiracil How Supplied in the drug label.
Storage
There is limited information regarding Trifluridine and tipiracil Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Trifluridine and tipiracil Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Trifluridine and tipiracil interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Trifluridine and tipiracil Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Trifluridine and tipiracil Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.