Decitabine and Cedazuridine
Decitabine and cedazuridine is a combination cancer medicine used to treat myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and — in combination with another drug — newly diagnosed acute myeloid leukemia (AML) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Decitabine and Cedazuridine: Patient Information Guide
A plain-language walkthrough of Decitabine and Cedazuridine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Decitabine and cedazuridine (sold as Inqovi) is a combination oral cancer medicine approved for several blood cancers in adults:
- Inqovi treats adults with myelodysplastic syndromes (MDS), covering previously treated and untreated disease, de novo (newly arising) and secondary MDS, across subtypes including refractory anemia, refractory anemia with ringed sideroblasts, and refractory anemia with excess blasts — spanning intermediate-1, intermediate-2, and high-risk disease groups
- Inqovi treats adults with chronic myelomonocytic leukemia (CMML)
- Inqovi in combination with venetoclax treats newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older, or adults of any age whose medical conditions rule out intensive induction chemotherapy
⚙️How it works▾
Decitabine works by slipping into the DNA of rapidly dividing cancer cells and blocking an enzyme called DNA methyltransferase. Normally, cancer cells use this enzyme to chemically silence genes that would otherwise tell them to stop growing or die. By blocking it, decitabine removes those silencing signals — a process called hypomethylation — allowing those important control genes to work again. This can push cancer cells to differentiate (become more normal) or undergo apoptosis (programmed cell death).
Cedazuridine protects decitabine from being destroyed by an enzyme in the gut and liver called cytidine deaminase (CDA). Without cedazuridine, very little oral decitabine would survive long enough to reach the bloodstream. Together, the two drugs deliver decitabine exposure by mouth that is comparable to intravenous decitabine.
💊How it's taken▾
Inqovi comes as a single combination tablet taken once daily for 5 consecutive days within each 28-day cycle. It must be taken on a completely empty stomach (at least 2 hours before or 2 hours after food) because eating — especially a high-fat meal — can cut the amount absorbed by roughly half. When used with venetoclax for AML, Inqovi should be taken 2 hours before or after the venetoclax dose, with both drugs starting on Day 1 of each cycle.
- Swallow the tablet whole; do not cut, crush, or chew
- Take at approximately the same time each day
- If you miss a dose within 12 hours of your usual time, take it as soon as possible and extend the cycle by one day to complete 5 total doses; if you vomit after a dose, do not take a replacement dose — continue with the next scheduled dose
- Inqovi is a hazardous drug; follow your pharmacist's guidance on safe handling and disposal
🤒Side effects — in detail▾
Most people taking Inqovi experience some side effects. The most common ones include:
- Fatigue or weakness
- Nausea
- Constipation
- Mouth sores (mucositis)
- Muscle aches (myalgia) and joint pain (arthralgia)
- Shortness of breath (dyspnea)
- Diarrhea
- Dizziness
- Rash
- Headache
- Decreased appetite
- Swelling (edema)
Seek immediate medical care if you develop a fever, signs of infection, unusual or heavy bleeding, or extreme tiredness — these can signal dangerously low blood counts, pneumonia, or sepsis, which are serious and potentially life-threatening complications of treatment.
⚠️Warnings & precautions▾
- Severe low blood counts (myelosuppression): This is the biggest risk. Inqovi commonly causes very low levels of white blood cells, red blood cells, and platelets, especially in the first two cycles. This increases the risk of serious infections (including pneumonia and sepsis), bleeding, and anemia. Fatal outcomes have occurred. Your blood counts will be monitored closely before every cycle.
- Serious infections: Pneumonia and sepsis have occurred in a meaningful number of patients and have been fatal in some. Report any fever, chills, or signs of infection to your care team right away.
- Fetal harm (embryo-fetal toxicity): Based on the drug's mechanism and animal studies, Inqovi can cause major birth defects or loss of pregnancy. It must not be used during pregnancy unless the risks are clearly discussed. Reliable contraception is required during treatment — 6 months after the last dose for women, 3 months for men.
- Male fertility: Based on animal data, Inqovi may impair sperm production. Whether this effect is reversible in humans is not yet known. Discuss fertility preservation options with your doctor before starting treatment if this is a concern.
🔀What it interacts with▾
Inqovi has one key drug interaction category to know about:
- Drugs broken down by cytidine deaminase (CDA): Cedazuridine blocks this enzyme throughout the body. If you take another medicine that relies on CDA to be cleared, that drug can build up to much higher — and potentially toxic — levels. Avoid combining Inqovi with CDA-metabolized drugs. Ask your pharmacist or prescriber to review your full medication list before starting treatment.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Tell your doctor immediately if you are pregnant or become pregnant — this medicine can cause serious birth defects and pregnancy loss
- Women of childbearing potential: A pregnancy test is required before starting Inqovi; use effective contraception during treatment and for 6 months after the last dose
- Men with partners who could become pregnant: Use effective contraception during treatment and for 3 months after the last dose
- Breastfeeding: Do not breastfeed during treatment or for 2 weeks after the last dose — the potential for serious harm to the infant is too high
- Fertility concerns: Inqovi may impair male fertility based on animal studies; discuss this with your doctor before starting
- Kidney impairment: No dose change is needed for mild or moderate kidney impairment, but patients with moderate impairment should be monitored more closely; Inqovi has not been studied in severe kidney impairment or dialysis-dependent patients
- Liver impairment: Mild liver impairment does not meaningfully affect how the drug behaves, but the effects of moderate or severe liver impairment are not yet well characterized
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults: Clinical studies included a high proportion of patients over 65 and 75 with no overall difference in safety or effectiveness; dose adjustments are still guided by individual blood counts and tolerability
📡Pharmacodynamics — effects in the body▾
Decitabine reduces the level of DNA methylation — the chemical silencing marks on DNA — in cancer cells both in lab studies and in patients. In people taking Inqovi at the recommended schedule, the greatest reduction in methylation is seen around Day 8 of the treatment cycle, and methylation does not fully return to its starting level by the end of the cycle. Higher total decitabine exposure over the 5-day course is associated with a greater likelihood of blood count side effects such as low neutrophils (neutropenia) and low platelets (thrombocytopenia). At up to twice the maximum recommended dose, cedazuridine does not cause any clinically meaningful lengthening of the heart's electrical cycle (QTc interval).
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, decitabine reaches peak blood levels in about 1 hour and cedazuridine in about 3 hours. Cedazuridine's protection of decitabine from gut and liver breakdown means that 5 days of once-daily Inqovi delivers essentially the same total decitabine exposure as 5 days of intravenous decitabine. Food — especially a high-fat meal — dramatically reduces decitabine absorption (cutting total exposure by about half and peak levels by about 75%), which is why the medicine must be taken on an empty stomach. Decitabine has a short half-life of about 1.5 hours at steady state, while cedazuridine lingers longer at about 6.7 hours. Decitabine is broken down primarily by the CDA enzyme and by natural chemical degradation; cedazuridine is eliminated roughly equally in urine and stool.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) .
📄 Written from Decitabine and Cedazuridine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Decitabine and Cedazuridine
17 supplements and herbal products have documented interactions with Decitabine and Cedazuridine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Decitabine and Cedazuridine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Inqovi treating in my body? ▾
Why do I have to take it on an empty stomach? Does it really matter? ▾
What side effects should I expect versus which ones mean I need to call someone right away? ▾
I'm on other medications. Are there any I need to worry about? ▾
Can I have children after taking this medicine? ▾
My blood counts are being checked all the time. Why, and what happens if they drop too low? ▾
Is Decitabine and Cedazuridine available over the counter? ▾
When was Decitabine and Cedazuridine first available? ▾
Who makes Decitabine and Cedazuridine? ▾
💬 Answers drafted from Decitabine and Cedazuridine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Decitabine and Cedazuridine comes
Decitabine and Cedazuridine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Inqovi tablets are used to treat adults with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS across several subtypes
- Inqovi tablets are used to treat adults with chronic myelomonocytic leukemia (CMML)
- Inqovi tablets are used in combination with venetoclax to treat newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or adults whose health conditions prevent intensive chemotherapy
- Inqovi: take one tablet by mouth once daily on Days 1 through 5 of each 28-day cycle
- Inqovi: take on a completely empty stomach — at least 2 hours before or 2 hours after eating; a high-fat meal can drastically reduce how much medicine you absorb
- Inqovi: swallow the tablet whole — do not cut, crush, or chew it
- Inqovi: when taken with venetoclax, take Inqovi 2 hours before or 2 hours after venetoclax
📊 Decitabine and Cedazuridine across the U.S. market
How Decitabine and Cedazuridine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Decitabine and Cedazuridine is used
A general measure of how commonly Decitabine and Cedazuridine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Decitabine and Cedazuridine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Decitabine and Cedazuridine prescribed? Of the 1,596 medications we measure, Decitabine and Cedazuridine ranks #1,503 by Medicaid prescriptions — more than 6% of them.
Utilization by Decitabine and Cedazuridine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Decitabine and Cedazuridine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 2 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Decitabine and Cedazuridine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Decitabine and Cedazuridine NDCs with Medicaid activity.
🔍 Compare Decitabine and Cedazuridine products
A representative set of FDA-listed product records for Decitabine and Cedazuridine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg/100 mg | — | BSP Pharmaceuticals S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| CEDAZURIDINE 100 mg/1; DECITABINE 35 mg | — | Otsuka Pharmaceutical Co., Ltd. | DRUG FOR FURTHER PROCESSING | View NDC → |
| CEDAZURIDINE 100 mg/1; DECITABINE 35 mg | Oral | Taiho Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 100; 35 mg/1; mg | Oral | Taiho Pharmaceutical Co., Ltd. | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Decitabine and Cedazuridine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Decitabine and Cedazuridine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Decitabine and Cedazuridine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Decitabine and Cedazuridine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Decitabine and Cedazuridine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Decitabine and Cedazuridine belongs to the Nucleoside Metabolic Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Taiho Pharmaceutical Co., Ltd. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.