Decitabine with cedazuridine

Source: UK SPC (eMC) 4.2 for Inaqovi 35 mg/100 mg film coated tablets (https://www.medicines.org.uk/emc/product/15177/smpc). VERBATIM: 'The recommended dose of Inaqovi is 1 tablet once daily on Days 1 through 5 of each 28-day cycle.' The SPC states the dose as one tablet - the 35 mg/100 mg strengths are taken from the product title; a complete or partial response may take longer than 4 cycles. PRESCRIBER RESTRICTION: treatment must be initiated and supervised by a physician experienced in the use of anticancer therapies. IMPORTANT: substitution with an intravenous decitabine product within a cycle is not recommended. Premedication with standard antiemetic therapy prior to each dose to minimise nausea and vomiting is to be considered. MISSED OR VOMITED DOSE: if a dose is missed within 12 hours of the usual time, take it as soon as possible and resume the normal daily schedule; if missed by 12 or more hours, wait and take the missed dose the following day at the usual time, then extend the dosing period by one day for every missed dose to complete 5 daily doses for that cycle; if the patient vomits after dosing, no additional dose is to be taken that day - the next dose is taken at the usual time with no extension of the dosing period. HAEMATOLOGIC DOSE ADJUSTMENT: delay the next cycle if absolute neutrophil count is below 1.0 x 10^9/L and platelets are below 50 x 10^9/L in the absence of active disease, and monitor full blood counts until ANC is 1.0 x 10^9/L or greater and platelets 50 x 10^9/L or greater. If haematological recovery occurs within 2 weeks of the last treatment cycle, continue at the same dose; if it does not occur within 2 weeks, delay treatment for up to 2 additional weeks AND resume at a reduced dose on Days 1 through 4. DOSE REDUCTIONS FOR MYELOSUPPRESSION (Table 1): first reduction - 1 tablet once daily on Days 1 through 4; second reduction - 1 tablet once daily on Days 1 through 3; third reduction - 1 tablet once daily on Days 1, 3 and 5. Dose may be maintained or increased in subsequent cycles as clinically indicated; patients with active disease are to be treated with a minimum of 4 cycles. Persistent severe neutropaenia and febrile neutropaenia have to be managed with supportive treatment. NON-HAEMATOLOGIC DOSE ADJUSTMENT: delay subsequent cycles and resume at the same or a reduced dose upon resolution for serum creatinine 2 mg/dL or greater; serum bilirubin 2 x ULN or greater; ALT or AST 2 x ULN or greater; or active or uncontrolled infection. Dose adjustments for all other Grade 3 or higher adverse reactions should follow institutional guidelines. HEPATIC IMPAIRMENT: studies in hepatic impairment have not been conducted and the need for dose adjustment has not been evaluated; monitor carefully if hepatic function worsens. PAEDIATRIC: safety and efficacy in patients under 18 years have not been established; no data are available. NOTE: the eMC 4.5 interactions section was not retrieved in this bundle, and the openFDA label in this bundle is for decitabine alone (not the decitabine/cedazuridine fixed combination) so it has deliberately NOT been used - source the UK SPC 4.5 separately.