What’s New New Drug Update - Decitabine/Cedazuridine

Elise Gill, Epic Pharmacy East Toowoomba

Brand: Inqovi 35mg/100mg tablets

Decitabine/cedazuridine is approved to treat chronic myelomonocytic leukaemia and myelodysplastic syndromes, which are disorders of stem cells. Patients who are not able to receive stem cell transplants have previously been treated with cytotoxic agents such as subcutaneous or intravenous azacitadine. This new combination of decitabine with cedazuridine allows an oral therapy option.

Decitabine has low oral bioavailability due to first-pass metabolism by the enzyme cytidine deaminase. Cedazuridine targets this enzyme to increase oral bioavailability. The fixed dose oral combination was proven to be highly similar to intravenous decitabine, with a 98% equivalence in systemic exposure when standard doses were compared.1 Furthermore, a phase III trial demonstrated the efficacy of the oral decitabine/cedazuridine combination to be consistent with intravenous decitabine clinical data, with 60% of patients responding and 21% showing a complete response after treatment.2

Decitabine/cedazuridine is taken once daily on days 1 to 5 of a 28 day cycle for a minimum of 4 cycles. The decitabine/cedazuridine combination should be taken on an empty stomach as food decreases absorption and patients should avoid combinations of gastric pH modifying medications as may affect cedazuridine bioavailability. No dose modifications are required in mild hepatic and mild to moderate renal impairment.3

Most patients will experience serious adverse effects from decitabine/cedazuridine. Common adverse effects include fatigue, nausea, dizziness, diarrhoea and constipation, however, more serious side effects, such as cytopenia, thrombocytopenia, anaemia, febrile neutropenia and pneumonia, can occur. As such, routine blood counts must be completed prior to treatment, and a dose reduction or delay may be required for some toxicities.

Whilst further investigations are required comparing decitabine/ cedazuridine directly with azacitadine, this new medication provides the first oral option for this patient group, decreasing the requirement for multiple hospital visits and injections per month.

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