Decitabine and Cedazuridine Combination Tablets (INQOVI) are an oral medication used for the treatment of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Its unique formulation enhances therapeutic efficacy by inhibiting DNA methylation and metabolic enzymes.

How to Use Decitabine and Cedazuridine Combination Tablets (INQOVI)

Dosing Regimen

The recommended dose of Decitabine and Cedazuridine Combination Tablets is 1 tablet per day (containing 35mg decitabine and 100mg cedazuridine). Each treatment cycle lasts 28 days, with continuous administration for 5 days (Days 1 to 5).

The tablets must be taken on an empty stomach. Avoid eating for 2 hours before and after administration to ensure drug absorption.

Precautions for Administration

Timing requirement: Take the tablet at a fixed time every day. Swallow the tablet whole; do not split or chew it.

Management of missed doses: If a dose is missed within 12 hours, take it immediately and continue with the original schedule. If more than 12 hours have passed, skip the missed dose and extend the subsequent cycle by 1 day to complete the total 5-day dose.

Management of vomiting: If vomiting occurs after administration, do not take an additional dose. Continue with the next scheduled dose as planned.

Treatment Cycles and Monitoring

It is recommended to complete at least 4 cycles to assess efficacy. Some patients may require a longer period to achieve complete or partial remission.

Regular monitoring of complete blood count is necessary during treatment, especially as myelosuppression may occur in the first cycle.

Dose Adjustment of Decitabine and Cedazuridine Combination Tablets (INQOVI)

Adjustment Related to Myelosuppression

Suspension criteria: If the absolute neutrophil count (ANC) is <1,000/µL or platelets are <50,000/µL, delay the next cycle until recovery (ANC ≥1,000/µL and platelets ≥50,000/µL).

Dose reduction plan:

First reduction: Administer once daily on Days 1 to 4.

Second reduction: Administer once daily on Days 1 to 3.

Third reduction: Administer once daily on Days 1, 3, and 5.

Adjustment for Non-Hematologic Toxicity

Dose adjustment is required in the following cases:

Serum creatinine ≥2mg/dL or liver enzymes (AST/ALT) ≥2 times the upper limit of normal.

Active infection or uncontrolled non-hematologic adverse reactions (e.g., severe rash).

Use in Special Populations for Decitabine and Cedazuridine Combination Tablets (INQOVI)

Patients with Renal Impairment

Mild to moderate impairment (CLcr 30-89mL/min): No dose adjustment is needed, but close monitoring of adverse reactions is required.

Severe impairment or end-stage renal disease (CLcr <30mL/min): Data are limited, so careful assessment is necessary.

Patients with Hepatic Impairment

Patients with mild to moderate hepatic impairment (total bilirubin ≤1.5 times the upper limit of normal): No dose adjustment is needed.

Patients with moderate to severe hepatic impairment: Data are insufficient, so individualized management is recommended.

Pregnant and Lactating Women

Pregnancy: INQOVI can cause fetal malformations. Women of childbearing age must use contraceptive measures during treatment and for 6 months after discontinuing the drug.

Lactation: Breastfeeding is prohibited during treatment and for 2 weeks after the last dose.

Impact on Fertility

The drug may impair fertility. Male patients must use contraceptive measures during treatment and for 3 months after discontinuing the drug.