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 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)

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