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Lonsurf Dosage

Generic name: TRIFLURIDINE 15mg, TIPIRACIL HYDROCHLORIDE 6.14mg
Dosage form: tablet, film coated
Drug class: Antineoplastic combinations

Medically reviewed by Drugs.com. Last updated on Aug 8, 2023.

Recommended Dosage

​The recommended dosage of LONSURF as a single agent or in combination with bevacizumab 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.

​Refer to the Prescribing Information for bevacizumab dosing information.

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)
BSA
(m2)		 Total daily
dose (mg)		 Dose (mg)
administered
twice daily		 Tablets per dose
15 mg 20 mg
< 1.07 70 35 1 1
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
≥2.30 160 80 0 4

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.

​Refer to the bevacizumab prescribing information for dose modifications for adverse reactions associated with bevacizumab.

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
dose (mg)		 Dose (mg)
administered
twice daily		 Tablets per dose
15 mg 20 mg
For a dose of 20 mg/m2 twice daily:
< 1.14 40 20 0 1
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
≥ 2.35 100 50 2 1
For a dose of 15 mg/m2 twice daily:
< 1.15 30 15 1 0
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
≥ 2.35 80 40 0 2

Frequently asked questions

Further information

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