Generic name: TRIFLURIDINE 15mg, TIPIRACIL HYDROCHLORIDE 6.14mg
Dosage form: tablet, film coated
Medically reviewed by Drugs.com. Last updated on Jan 14, 2020.
The recommended dosage of LONSURF is 35 mg/m2 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.
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)
|Tablets per dose|
|1.07 - 1.22||80||40||0||2|
|1.23 - 1.37||90||45||3||0|
|1.38 - 1.52||100||50||2||1|
|1.53 - 1.68||110||55||1||2|
|1.69 - 1.83||120||60||0||3|
|1.84 - 1.98||130||65||3||1|
|1.99 - 2.14||140||70||2||2|
|2.15 - 2.29||150||75||1||3|
Dosage Modifications for Adverse Reactions
Obtain complete blood cell counts prior to and on Day 15 of each cycle [see Warnings and Precautions (5.1)].
Do not initiate the cycle of LONSURF until:
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 or febrile neutropenia is resolved
- Platelets greater than or equal to 75,000/mm3
- Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1
Within a treatment cycle, withhold LONSURF for any of the following:
- Absolute neutrophil count (ANC) less than 500/mm3 or febrile neutropenia
- Platelets less than 50,000/mm3
- Grade 3 or 4 non-hematologic adverse reaction
After recovery, resume LONSURF after reducing the dose by 5 mg/m2/dose from the previous dose, if the following occur:
- Febrile neutropenia
- Uncomplicated Grade 4 neutropenia (which has recovered to greater than or equal to 1,500/mm3) or thrombocytopenia (which has recovered to greater than or equal to 75,000/mm3) that results in more than 1 week delay in start of next cycle
- Non-hematologic Grade 3 or Grade 4 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. Permanently discontinue LONSURF in patients who are unable to tolerate a dose of 20 mg/m2 orally twice daily. Do not escalate LONSURF dosage after it has been reduced.
Recommended Dosage for Renal Impairment
Severe Renal Impairment
In patients with severe renal impairment [creatinine clearance (CLcr) of 15 to 29 mL/min as determined by the Cockcroft-Gault formula], the recommended dosage is 20 mg/m2 (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 (Table 2) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Reduce dose to 15 mg/m2 twice daily in patients with severe renal impairment who are unable to tolerate a dose of 20 mg/m2 twice daily (Table 2). Permanently discontinue LONSURF in patients who are unable to tolerate a dose of 15 mg/m2 twice daily.
Table 2 Recommended Dosage for Severe Renal Impairment According to BSA
* For a total daily dose of 50 mg, instruct patients to take 1 x 20-mg tablet in the morning and 2 x 15-mg tablets in the evening.
|BSA (m2)||Total daily
|Tablets per dose|
|For a dose of 20 mg/m2 twice daily:|
|1.14 – 1.34||50||25*||2 in the evening*||1 in the morning*|
|1.35 – 1.59||60||30||2||0|
|1.60 – 1.94||70||35||1||1|
|1.95 – 2.09||80||40||0||2|
|2.10 – 2.34||90||45||3||0|
|For a dose of 15 mg/m2 twice daily:|
|1.15 – 1.49||40||20||0||1|
|1.50 – 1.84||50||25*||2 in the evening*||1 in the morning*|
|1.85 – 2.09||60||30||2||0|
|2.10 – 2.34||70||35||1||1|
Frequently asked questions
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