Trifluridine with tipiracil (Specialist drug)

eMC SPC for Trifluridine/Tipiracil Servier 15 mg/6.14 mg film-coated tablets (previously known as Lonsurf). Should be prescribed by physicians experienced in the administration of anticancer therapy. The same 35 mg/m² twice-daily starting dose applies as monotherapy or in combination with bevacizumab; when used with bevacizumab for metastatic colorectal cancer the bevacizumab dose is 5 mg/kg body weight once every 2 weeks (refer to the full bevacizumab product information). BSA-BANDED STARTING DOSE (mg twice daily): <1.07 m² = 35 mg; 1.07–1.22 = 40 mg; 1.23–1.37 = 45 mg; 1.38–1.52 = 50 mg; 1.53–1.68 = 55 mg; 1.69–1.83 = 60 mg; 1.84–1.98 = 65 mg; 1.99–2.14 = 70 mg; 2.15–2.29 = 75 mg; ≥2.30 = 80 mg. Missed or held doses must not be made up. DOSE MODIFICATION: a maximum of 3 dose reductions is permitted, in 5 mg/m²/dose steps, to a minimum of 20 mg/m² twice daily (or 15 mg/m² twice daily in severe renal impairment); dose escalation is not permitted after a reduction. Interrupt for neutrophils <0.5 × 10⁹/L or platelets <50 × 10⁹/L and resume when neutrophils ≥1.5 × 10⁹/L and platelets ≥75 × 10⁹/L (the resumption criterion applies to the start of every cycle). Also interrupt for febrile neutropenia, Grade 4 neutropenia (<0.5 × 10⁹/L) or thrombocytopenia (<25 × 10⁹/L) delaying the next cycle by more than 1 week, or Grade 3–4 non-haematological reactions (except Grade 3 nausea/vomiting controlled by antiemetics, or diarrhoea responsive to antidiarrhoeals), resuming one dose level lower once toxicity resolves to Grade 1 or baseline. HEPATIC: no starting-dose adjustment in mild hepatic impairment; administration is NOT recommended in baseline moderate or severe hepatic impairment (total bilirubin >1.5 × ULN). ELDERLY: no starting-dose adjustment at ≥65 years; efficacy and safety data over 75 years are limited. PAEDIATRIC: there is no relevant use of trifluridine/tipiracil in the paediatric population for the indications of metastatic colorectal cancer and metastatic gastric cancer. SOURCE NOTES: eMC §4.5 (interactions) was not captured in the fetched bundle. The openFDA record in this bundle is trifluridine OPHTHALMIC solution — a different product and indication — and was not used.