Tipiracil / Trifluridine Dosage
Medically reviewed by Drugs.com. Last updated on Mar 20, 2024.
Applies to the following strengths: 8.19 mg-20 mg; 6.14 mg-15 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Colorectal Cancer
- Initial dose: 35 mg/m2 orally 2 times a day on Days 1 through 5 and Days 8 through 12 of each 28-day cycle
- Maximum dose: 80 mg per dose (based on trifluridine component)
- Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
- The dose should be rounded to the nearest 5 mg increment.
- Do not initiate a cycle of this drug until absolute neutrophil count (ANC) is 1500/mm3 or greater or febrile neutropenia is resolved; platelets are 75,000/mm3 or greater; and Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1.
Uses:
- 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 an anti-EGFR therapy (if RAS wild-type).
- Treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Usual Adult Dose for Gastric Cancer
- Initial dose: 35 mg/m2 orally 2 times a day on Days 1 through 5 and Days 8 through 12 of each 28-day cycle
- Maximum dose: 80 mg per dose (based on trifluridine component)
- Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
- The dose should be rounded to the nearest 5 mg increment.
- Do not initiate a cycle of this drug until absolute neutrophil count (ANC) is 1500/mm3 or greater or febrile neutropenia is resolved; platelets are 75,000/mm3 or greater; and Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1.
Uses:
- 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 an anti-EGFR therapy (if RAS wild-type).
- Treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Renal Dose Adjustments
- Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
- Severe renal impairment (CrCl less than 30 mL/min): Data not available
Liver Dose Adjustments
- Mild hepatic impairment: No adjustment recommended.
- Moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN and any AST): Not recommended.
Dose Adjustments
- A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 orally 2 times a day.
- The dose should not be escalated after it has been reduced.
Within a therapy cycle, withhold this drug for any of the following:
- ANC less than 500/mm3 or febrile neutropenia
- Platelets less than 50,000/mm3
- Grade 3 or 4 nonhematologic adverse reactions
After recovery, therapy should be resumed after reducing the dose by 5 mg/m2/dose from the previous dose level if the following occur:
- Febrile neutropenia
- Uncomplicated Grade 4 neutropenia (which has recovered to 1500/mm3 or greater) or thrombocytopenia (which has recovered to 75,000/mm3 or greater) that results in more than 1-week delay in start of next cycle
- Nonhematologic Grade 3 or 4 adverse reaction except for Grade 3 nausea and/or
Precautions
CONTRAINDICATIONS:
- None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug should be taken with meals.
- The tablet should be swallowed whole.
- Additional doses should not be taken to make up for missed, vomited, or held doses.
- Handling and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
Storage requirements:
- This drug should be discarded after 30 days if stored outside of original bottle.
General:
- This drug consists of trifluridine and tipiracil at a molar ratio of 1:0.5.
- There is no known antidote for overdose with this drug; the highest dose administered in studies was 180 mg/m2 per day.
Monitoring:
- CBC prior to and on Day 15 of each cycle
Patient advice:
- This drug is available in two strengths; you may receive both strength tablets to provide your prescribed dose.
- Patients and caregivers need to wear gloves or wash hands when handling this drug.
More about tipiracil / trifluridine
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