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Tipiracil / Trifluridine Dosage

Applies to the following strength(s): 8.19 mg-20 mg ; 6.14 mg-15 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Colorectal Cancer

-Initial dose: 35 mg/m2 orally twice a day on Days 1 through 5 and Days 8 through 12 of each 28-day cycle (based on trifluridine component)
-Maximum dose: 80 mg per dose (based on trifluridine component)
-Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-Dose should be taken within 1 hour of completion of morning and evening meals.
-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 1,500/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.

Use: 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).

Renal Dose Adjustments

Renal Dysfunction:
-Mild Renal Dysfunction (CrCl 60 to 89 mL/min): No adjustment recommended.
-Moderate Renal Dysfunction (CrCl 30 to 59 mL/min): Dose adjustment may be required for increased toxicity; however, no specific guidelines have been suggested. Caution is recommended.
-Severe Renal Dysfunction (CrCl less than 30): Data not available.

Liver Dose Adjustments

-Mild Liver Dysfunction (Total bilirubin [TB] upper limit of normal [ULN] or less and AST greater than ULN or TB less than 1 to 1.5 times ULN and any AST): No adjustment recommended.
-Moderate Liver Dysfunction (TB greater than 1.5 to 3 times ULN and any AST): Data not available.
-Severe Liver Dysfunction (TB greater than 3 times ULN and any AST): Data not available.

Dose Adjustments

Within a Treatment 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 non-hematological adverse reactions

After Recovery, the Treatment 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 ANC 1,500/mm3 or greater) or thrombocytopenia (which has recovered to platelets 75,000/mm3 or greater) that results in more than 1 week delay in start of next cycle
-Grade 3 or 4 non-hematological adverse reaction except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication
-A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 orally twice a day.
-The dose should not be escalated after it has been reduced.

Precautions

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:
-Additional doses should not be taken to make up for missed 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 overdosage 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.

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