Lonsurf Dosage/Direction for Use

Recommended Dosage: 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 within one hour of completion of morning and evening meals 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.
Table 3 shows the calculated initial daily dose based on body surface area (BSA). (See Table 3.)

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Dosage Modifications for Adverse Reactions: Obtain complete blood cell counts prior to and on Day 15 of each cycle. [See Severe Myelosuppression under Precautions.]
Do not initiate the cycle of Lonsurf until: Absolute neutrophil count (ANC) is greater than or equal to 1,500/mm³ or febrile neutropenia is resolved; Platelets are 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-hematological adverse reactions.
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 initial dosage is 20 mg/m² (based on the trifluridine component) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle (Table 4) [see Renal Impairment under Precautions; Pharmacology: Pharmacokinetics under Actions]. 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 4). Permanently discontinue Lonsurf in patients who are unable to tolerate a dose of 15 mg/m² twice daily. (See Table 4.)

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