Decitabine and Cedazuridine Tablets (INQOVI) is an oral targeted drug used for the treatment of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

Precautions for Administration of Decitabine and Cedazuridine Tablets (INQOVI)

Dosage Regimen and Administration Requirements

Dosage and Cycle: The recommended dosage is 1 tablet (containing 35 mg decitabine + 100 mg cedazuridine) per day, taken continuously for 5 days (Days 1-5). A treatment cycle is 28 days, and at least 4 cycles should be completed.

A therapeutic response may take a longer time, so continuous medication is required until disease progression or intolerable toxicity occurs.

Fasting Administration: Fasting is required for 2 hours before and after taking the medicine to avoid the impact of food on absorption. The tablet should be swallowed whole and must not be split, chewed, or crushed.

Management of Missed Dose: If a dose is missed within 12 hours, it can be taken as a supplement, and the treatment course should be extended by 1 day to complete the 5-day dosage. If vomiting occurs after administration, no supplementary dose is needed, and the next dose should be taken as scheduled.

Contraindications in Special Populations

Contraindicated in Pregnancy: Animal studies have shown teratogenicity, so pregnant women must use strict contraception. Female patients should take effective contraceptive measures during treatment and within 6 months after the last dose; male patients should take effective contraceptive measures within 3 months after the last dose.

Lactation: Breastfeeding is prohibited during treatment and within 2 weeks after stopping the medication.

Hepatic and Renal Impairment: There is insufficient data on patients with moderate to severe renal impairment (CrCl < 30 mL/min) and severe hepatic impairment, so careful evaluation is required.

Adverse Reaction Risk Warnings

Myelosuppression: 82% of patients experience thrombocytopenia, and 73% experience neutropenia, which may cause life-threatening infections or bleeding. Regular monitoring of blood routine is necessary, and the next cycle should be delayed until hematological recovery.

Embryotoxicity: Even low doses may cause fetal malformations, so it is necessary to fully inform women of childbearing age about the risks.

Drug Interactions: Cedazuridine inhibits cytidine deaminase (CDA). Concomitant use of drugs metabolized by CDA (such as cytarabine) should be avoided to prevent increased toxicity.

Medication Monitoring for Decitabine and Cedazuridine Tablets (INQOVI)

Pre-Treatment Evaluation

Baseline Examinations: Including complete blood count (CBC), liver and kidney function (AST/ALT, creatinine), and pregnancy test (for women of childbearing age).

Infection Screening: Active infections must be controlled before initiating treatment.

Intra-Treatment Monitoring

Hematological Monitoring: CBC should be rechecked before each cycle and when clinically indicated, with focus on neutrophils (ANC ≥ 1000/μL) and platelets (≥ 50000/μL).

Non-Hematological Toxicity: If serum creatinine ≥ 2 mg/dL, transaminase ≥ 2 times the upper limit, or severe infection occurs, treatment should be suspended until recovery.