Fruquintinib (Specialist drug)

INITIATION: should be initiated by a physician experienced in the administration of anticancer therapy. DURATION: continue until disease progression or unacceptable toxicity occurs. MISSED DOSE: if a dose is missed by less than 12 hours it should be taken and the next dose taken as scheduled; if missed by more than 12 hours it should be skipped and the next dose taken as scheduled. VOMITING: if a patient vomits after taking a dose, the dose should not be repeated on the same day — resume the usual dosing on the following day. DOSE REDUCTIONS: first dose reduction 4 mg once daily (four 1 mg capsules); second dose reduction 3 mg once daily (three 1 mg capsules). Permanently discontinue in patients unable to tolerate a dose of 3 mg once daily. TOXICITY MODIFICATIONS: Grade 3 hypertension persisting despite antihypertensive treatment — withhold; resume at a reduced dose if it recovers to Grade 1 or baseline, and discontinue permanently if Grade 3 hypertension recurs on 3 mg daily. Grade 4 hypertension — permanently discontinue. Grade 2 haemorrhagic events — withhold until bleeding fully resolves or recovers to Grade 1, then resume at a reduced dose; Grade 3 or higher — permanently discontinue. Proteinuria of 2 g/24 hours or more — withhold until it fully resolves or is below 1 g/24 hours, then resume at a reduced dose; permanently discontinue for nephrotic syndrome. Liver function test abnormalities (ALT or AST more than 3 times ULN, or bilirubin more than 1.5 times ULN) — withhold until recovery to Grade 1 or baseline then resume at a reduced dose; permanently discontinue if ALT or AST is more than 3 times ULN with concurrent total bilirubin more than 2 times ULN (absent alternative aetiologies), or if AST/ALT exceeds 20 times ULN or bilirubin exceeds 10 times ULN. Grade 2 palmar-plantar erythrodysesthesia syndrome — supportive treatment, withhold until recovery to Grade 1 or baseline, resume at the same dose level; Grade 3 — withhold then resume at a reduced dose. Other Grade 3 adverse reactions — withhold then resume at a reduced dose; Grade 4 — discontinue, considering resumption at a reduced dose only if the toxicity recovers to Grade 1 or baseline and the benefit outweighs the risk. HEPATIC IMPAIRMENT: no dose adjustment for mild or moderate impairment; not recommended in severe hepatic impairment, as it has not been studied in this population. ELDERLY: no dose adjustment required in patients aged 65 years or above. PAEDIATRIC: the safety and efficacy in children aged 0 to under 18 years have not been established and no data are available. SOURCE CAVEAT: the fetched SPC sections 4.4 and 4.8 were truncated at the source-fetch limit, and section 4.5 (interactions) was not retrieved — the interaction entry below comes from the US label.