Decinjet

Adults w/ newly diagnosed de novo or secondary AML, according to WHO classification, who are not candidates for standard induction chemotherapy.

IV infusion 20 mg/m² over 1 hr daily for 5 consecutive days (ie, total of 5 doses per treatment cycle). Max total daily dose: 20 mg/m². Max total dose per treatment cycle: 100 mg/m². Repeat cycle every 4 wk depending on patient response & observed toxicity. Treatment duration: Min of 4 cycles. May be continued as long as patient shows response, continues to benefit or exhibits stable disease. Complete or partial remission may take longer than 4 cycles.

Hypersensitivity. Breast-feeding.

Interrupt or delay treatment in the presence of myelosuppression or its complications eg, febrile neutropenia (temp ≥38.5°C & ANC <1,000/microliter), acute viral, bacterial or fungal infection (ie, requiring IV anti-infectives or extensive support care), haemorrhage (GI, genito-urinary, pulmonary w/ platelets <25,000/microliter or any CNS haemorrhage. Consider treatment w/ high-dose IV corticosteroids & haemodynamic monitoring at first onset of symptoms or signs suggestive of differentiation syndrome, & temporary discontinuation until resolution of symptoms. May exacerbate myelosuppression & its complications including infections & bleeding. ILD (including pulmonary infiltrates, organising pneumonia & pulmonary fibrosis) w/o signs of infectious aetiology. Cardiomyopathy w/ cardiac decompensation. Monitor patients for signs & symptoms of infection; heart failure in those w/ cardiac disease history. Perform complete blood & platelet counts regularly; careful assessment of patients w/ acute onset or unexplained worsening of pulmonary symptoms; liver & renal function tests prior to initiation of therapy & each treatment cycle, & as clinically indicated. Patients w/ history of severe CHF or clinically unstable cardiac disease. Contains Na. Moderate influence on ability to drive & use machines. Hepatic impairment & patients who develop signs or symptoms of hepatic impairment. Severe renal impairment (CrCl <30 mL/min). Men should use contraceptive measures & should not father a child during & for 3 mth after treatment. Women of childbearing potential must use effective contraceptive measures & avoid becoming pregnant during & for 6 mth after treatment; seek consultation regarding oocyte cryopreservation prior to initiation of treatment. Perform pregnancy test before starting treatment. Not to be used during pregnancy & in women of childbearing potential not using effective contraception. Discontinue breastfeeding during treatment. Not to be used in childn <18 yr w/ AML.

Pneumonia, UTI, viral, bacterial & fungal infections; febrile neutropaenia, neutropaenia, thrombocytopaenia, anaemia, leukopaenia; hyperglycaemia; headache; epistaxis; diarrhoea, vomiting, nausea; abnormal hepatic function; pyrexia. Septic shock, sepsis, sinusitis; hypersensitivity including anaphylactic reaction; stomatitis; hyperbilirubinemia.

Concomitant use w/ agents activated by sequential phosphorylation (via intracellular phosphokinase activities) &/or metabolised by enzymes implicated in the inactivation of decitabine (eg, cytidine deaminase).

Cytotoxic Chemotherapy

L01BC08 - decitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

S