Usual Adult Dose for Myelodysplastic Syndrome

1 tablet (containing 100 mg cedazuridine and 35 mg decitabine) orally once daily on Days 1 through 5 of each 28-day cycle for a minimum of 4 cycles until disease progression or unacceptable toxicity; a complete or partial response may take longer than 4 cycles

Comments:

• Consider administering antiemetics prior to each dose to minimize nausea and vomiting.

Use: For myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups

Renal Dose Adjustments

Mild (CrCl 60 to less than 90 mL/min) or moderate (CrCl 30 to less than 60 mL/min): No adjustment recommended.
Severe (15 to less than 30 mL/min) or end-stage (CrCl less than 15 mL/min) renal impairment: Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Obtain complete blood cell counts prior to initiating therapy and before each cycle; delay the next cycle if absolute neutrophil count (ANC) is less than 1000/microliter and platelets are less than 50,000/microliter in the absence of active disease. Monitor complete blood cell counts until ANC is 1000/microliter or greater and platelets are 50,000/microliter or greater.

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not substitute this drug combination for an IV decitabine product within a cycle.
• Take this drug at the same time each day.
• Swallow tablets whole; do not cut, crush, or chew tablets.
• Take this drug on an empty stomach 2 hours before or 2 hours after food.
• If a dose is missed within 12 hours of the time it is usually taken, take the missed dose as soon as possible and then to resume the 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 but continue with the next schedule dose.

Monitoring:

• Absolute neutrophil count (ANC)
• Complete blood cell count
• Platelets