Lonsurf Dosage/Direction for Use

Lonsurf should be prescribed by physicians experienced in the administration of anticancer therapy.
Posology: The recommended starting dose of Lonsurf in adults, as monotherapy or in combination with bevacizumab, is 35 mg/m²/dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle until disease progression or unacceptable toxicity (see Precautions).
When Lonsurf is used in combination with bevacizumab for the treatment of metastatic CRC, the dose of bevacizumab is 5 mg/kg of body weight given once every 2 weeks. Refer to the full product information for bevacizumab.
The dose is calculated according to body surface area (BSA) (see Table 4). The dose must not exceed 80 mg/dose.
If doses were missed or held, the patient must not make up for missed doses. (See Table 4.)

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Recommended dose adjustments: Dosing adjustments may be required based on individual safety and tolerability.
A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m² twice daily. Dose escalation is not permitted after it has been reduced.
In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Tables 5, 6 and 7. (See Tables 5, 6 and 7.)

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Special populations: Renal impairment: Mild renal impairment (CrCl 60 to 89 mL/min) or moderate renal impairment (CrCl 30 to 59 mL/min): No adjustment of the starting dose is recommended in patients with mild or moderate renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Severe renal impairment (CrCl 15 to 29 mL/min): For patients with severe renal impairment a starting dose of 20 mg/m² twice daily is recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions). One dose reduction to a minimum dose of 15 mg/m² twice daily is permitted based on individual safety and tolerability (see Table 8). Dose escalation is not permitted after it has been reduced.
In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 5, Table 6 and Table 8. (See Table 8.)

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End stage renal disease (CrCl below 15 mL/min or requiring dialysis): Administration is not recommended in patients with end stage renal disease as there are no data available for these patients (see Precautions).
Hepatic impairment: Mild hepatic impairment: No adjustment of the starting dose is recommended in patients with mild hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Moderate or severe hepatic impairment: Administration is not recommended in patients with baseline moderate or severe hepatic impairment (National Cancer Institute [NCI] Criteria Group C and D defined by total bilirubin >1.5 x ULN) as, a higher incidence of Grade 3 or 4 hyperbilirubinaemia is observed in patients with baseline moderate hepatic impairment, although this is based on very limited data (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Elderly: No adjustment of the starting dose is required in patients ≥65 years old (see Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). Efficacy and safety data in patients over 75 years old is limited.
Paediatric population: There is no relevant use of Lonsurf in the paediatric population for the indication of metastatic colorectal cancer and metastatic gastric cancer.
Race: No adjustment of the starting dose is required on the basis of patient's race (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). There is limited data on Lonsurf in Black/African American patients but there is no biological rationale to expect any difference between this subgroup and the overall population.
Method of administration: Lonsurf is for oral use. The tablets must be taken with a glass of water within 1 hour after completion of the morning and evening meals.