Gilteritinib

SOURCE: no UK SPC was fetched in this bundle (providers.emc is null) — this draft is distilled from the US Xospata prescribing information and must be verified against the UK SPC. PATIENT SELECTION: select patients for treatment of AML on the basis of a FLT3 mutation in blood or bone marrow. MISSED DOSE: administer as soon as possible on the same day and at least 12 hours before the next scheduled dose, then return to the normal schedule the following day; do not administer 2 doses within 12 hours. MONITORING: assess blood counts and blood chemistries including creatine phosphokinase before initiation, at least once weekly for the first month, once every other week for the second month, and once monthly thereafter; perform an ECG before initiation, on days 8 and 15 of cycle 1, and before the start of the next two subsequent cycles. DOSE MODIFICATIONS: differentiation syndrome — if suspected, give systemic corticosteroids and start haemodynamic monitoring until symptom resolution and for a minimum of 3 days, interrupt if severe signs and/or symptoms persist for more than 48 hours after starting corticosteroids, and resume when signs and symptoms improve to Grade 2 or lower; posterior reversible encephalopathy syndrome — discontinue; QTc interval greater than 500 msec — interrupt and resume at 80 mg when the QTc returns to within 30 msec of baseline or to 480 msec or less; QTc increased by more than 30 msec on the day 8 ECG of cycle 1 — confirm with an ECG on day 9 and, if confirmed, consider dose reduction to 80 mg; pancreatitis — interrupt until resolved then resume at 80 mg; other Grade 3 or higher treatment-related toxicity — interrupt until the toxicity resolves or improves to Grade 1 then resume at 80 mg. Correct hypokalaemia or hypomagnesaemia before and during treatment. PAEDIATRIC: safety and effectiveness in paediatric patients have not been established — no paediatric dose exists; verify against a children's formulary and the local protocol.