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Lonsurf Dosage

Generic name: TRIFLURIDINE 15mg, TIPIRACIL HYDROCHLORIDE 6.14mg
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Jan 14, 2020.

Recommended Dosage

‚ÄčThe 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)

BSA
(m2)
Total daily
dose (mg)
Dose (mg)
administered
twice daily
Tablets per dose
15mg 20mg
<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.

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
15mg 20mg
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.