Decitabine– inhibits DNA methyltransferase, causing apoptosis; has more effect on rapidly replicating cells. Cedazuridine– acts as a cytidine deaminase inhibitor, preventing the degradation of decitabine in the GI tract and liver; leads to an increase in systemic exposure of decitabine.
Decreased progression of disease and improved rate of conversion from bring transfusion dependent to independent of red blood cell and platelet transfusions.
Monitor for signs and symptoms of infection (fever, chills, sore throat) during therapy. If active or uncontrolled infection occurs, delay next cycle and resume at same or reduced dose when resolved.
Lab Test Considerations:
Verify negative pregnancy test before starting therapy.
Obtain CBC prior to each cycle and as clinically indicated. Administer growth factors and anti-infectives for treatment or prophylaxis. If ANC <1,000/mm3 and platelets <50,000/mm3 in the absence of active disease, delay next cycle. Monitor CBC until recovery (ANC ≥1,000/mm3 and platelets ≥50,000/mm3 ). If recovery occurs within 2 wks of achieving remission, continue at same dose. If recovery does not occur within 2 wks, delay cycle for up to 2 additional wks and resume at reduced dose on Days 1–4. May require further dose reductions.
If serum creatinine ≥2 mg/dL OR serum bilirubin≥2 × ULN OR AST or ALT ≥2 × ULN, delay next cycle and resume at same or reduced dose when resolved.
Instruct patient to take medication as directed once daily for 5 days in each cycle. Take missed doses as soon as possible within 12 hrs of the time it is usually taken, and then to resume normal daily dosing schedule. Extend the dosing period by one day for every missed dose to complete 5 daily doses for each cycle. Do not take an additional dose if vomiting occurs after administration but continue with next scheduled dose. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patient to notify health care professional promptly is signs and symptoms of low blood cell counts (fever, chills, body aches, bruising more easily than usual) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.
Rep: May cause fetal harm. Advise females or reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding during and for at least 2 wk after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. May impair fertility in males.