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Inqovi

decitabine-cedazuridine
Hypomethylating AgentFDA Approved 2020Taiho Oncology / Astex
Route
Oral
Half-Life
~1 hr
FDA Approved
2020
Manufacturer
Taiho Oncology / Astex
1. Indications and Usage

Adults with MDS (IPSS int-1/2 and high-risk) and CMML.

2. Dosage and Administration

35 mg decitabine / 100 mg cedazuridine orally once daily on Days 1-5 of each 28-day cycle.

3. Dosage Forms and Strengths

Tablets: 35 mg/100 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Myelosuppression: Including febrile neutropenia. Monitor CBCs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (50%), Constipation (44%), Hemorrhage (40%), Neutropenia (38%), Myalgia (36%), Nausea (34%), Mucositis (32%), Arthralgia (30%), Pyrexia (28%), Diarrhea (26%)

Fatigue
50%
Constipation
44%
Hemorrhage
40%
Neutropenia
38%
Myalgia
36%
Nausea
34%
Mucositis
32%
Arthralgia
30%
Pyrexia
28%
Diarrhea
26%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No clinically significant interactions. Cedazuridine inhibits CDA-mediated metabolism of decitabine.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Decitabine inhibits DNA methyltransferase causing hypomethylation and cytotoxicity to abnormal hematopoietic cells. Cedazuridine inhibits CDA, enabling oral delivery with IV-equivalent exposure.

Pharmacokinetics

Decitabine: Tmax 1 hour, half-life ~1.5 hours. Cedazuridine: Tmax 3 hours, half-life ~7 hours.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Decitabine-Cedazuridine Trials on ClinicalTrials.gov ↗ 📚 PubMed: Decitabine-Cedazuridine Clinical Trials ↗
FDA-Approved Tumor Types

Consult the prescribing information for complete indication details and associated tumor types.

External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Inqovi. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Inqovi (decitabine-cedazuridine) approved for?

Inqovi (decitabine-cedazuridine) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Inqovi (decitabine-cedazuridine) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Inqovi (decitabine-cedazuridine) work?

Decitabine inhibits DNA methyltransferase causing hypomethylation and cytotoxicity to abnormal hematopoietic cells. Cedazuridine inhibits CDA, enabling oral delivery with IV-equivalent exposure.

What are the most common side effects?

Fatigue (50%), Constipation (44%), Hemorrhage (40%), Neutropenia (38%), Myalgia (36%), Nausea (34%), Mucositis (32%), Arthralgia (30%), Pyrexia (28%), Diarrhea (26%) Fatigue 50% Constipation 44% Hemorrhage 40% Neutropenia 38% Myalgia 36% Nausea 34% Mucositis 32% Arthralgia 30% Pyrexia 28% Diarrhea 2

← All TherapiesFull Prescribing Information ↗