Decitabine

Source: UK SPC (eMC) 4.2 for Dacogen 50 mg powder for concentrate for solution for infusion (https://www.medicines.org.uk/emc/product/2838/smpc). VERBATIM: 'In a treatment cycle, Dacogen is administered at a dose of 20 mg/m2 body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle).' PRESCRIBER RESTRICTION: administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic medicinal products. DURATION: patients should be treated for a minimum of 4 cycles, but a complete or partial remission may take longer than 4 cycles to be obtained; treatment may be continued as long as the patient shows response, continues to benefit or exhibits stable disease (in the absence of overt progression). If after 4 cycles haematological values (e.g. platelet count or absolute neutrophil count) have not returned to pre-treatment levels, or if disease progression occurs (rising peripheral blast counts or worsening bone marrow blast counts), the patient may be considered a non-responder and alternative therapeutic options should be considered. MISSED DOSE: if a dose is missed, treatment should be resumed as soon as possible. PREMEDICATION: pre-medication for prevention of nausea and vomiting is not routinely recommended but may be administered if required. MYELOSUPPRESSION MANAGEMENT: treatment may be delayed at the discretion of the treating physician for myelosuppression-associated complications such as febrile neutropaenia (temperature 38.5 C or above with absolute neutrophil count below 1,000/microlitre); active viral, bacterial or fungal infection requiring intravenous anti-infectives or extensive supportive care; or haemorrhage (gastrointestinal, genito-urinary or pulmonary with platelets below 25,000/microlitre, or any central nervous system haemorrhage). Treatment may be resumed once these conditions have improved or stabilised with adequate treatment (anti-infective therapy, transfusions or growth factors). In clinical studies approximately one-third of patients required a dose delay. DOSE REDUCTION IS NOT RECOMMENDED. HEPATIC IMPAIRMENT: studies in hepatic impairment have not been conducted and the need for dose adjustment has not been evaluated; if worsening hepatic function occurs, patients should be carefully monitored. PAEDIATRIC: should not be used in children with AML aged under 18 years, because efficacy was not established. NOTE: the eMC 4.5 interactions section was not retrieved in this bundle - the interaction statement below is taken from the US decitabine prescribing information and must be checked against the UK SPC 4.5.