Onureg (azacitidine (oral))
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Azacitidine (oral) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Azacitidine (oral)
- Brand name
- Onureg
- Development code
- CC-486
- Drug class
- Hypomethylating agent (nucleoside metabolic inhibitor)
- Manufacturer
- Bristol Myers Squibb
- How it's taken
- Oral tablet once daily, 14 days of each 28-day cycle
A maintenance tablet taken 14 days of every 28 by adults with AML who reached a first complete remission after intensive induction chemotherapy and cannot go on to complete intensive curative treatment such as a transplant. Approved September 1, 2020. It is not interchangeable with injected azacitidine.
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Where Azacitidine (oral) fits
The only FDA-approved maintenance treatment for AML in first remission after intensive chemotherapy. Vanflyta is approved as maintenance after consolidation specifically for FLT3-ITD AML.
How Azacitidine (oral) works
Like injected azacitidine, the oral form is taken up by dividing cells, built into their DNA and RNA, and blocks DNA methyltransferase so that silenced genes are re-expressed[1]. Taken for 2 weeks of each month after remission, it is meant to suppress the small number of leukemia cells that survive induction and would otherwise cause relapse. The oral tablet gives a lower, longer exposure than the injection, which is why its dose and schedule are different and why the label says the 2 products must never be swapped[1].
Mechanism: Oral hypomethylating agent that keeps low-level pressure on residual leukemia cells after remission
Side effects and safety
- Not interchangeable. Onureg's dose and schedule differ from IV or injected azacitidine; substituting one for the other can cause overdose or underdose.
- Myelosuppression. New or worse low blood counts; counts every 2 weeks for 2 cycles, then before each cycle; hold if neutrophils under 0.5 Gi/L on day 1.
- Severe liver impairment. People with severe hepatic impairment were not studied and may have more side effects.
- Embryo-fetal toxicity. Can harm an unborn baby; contraception during treatment and for 6 months after (women) or 3 months after (men).
- Complete blood counts every other week for the first 2 cycles, then before each cycle
- Liver function in people with liver disease
- Pregnancy test before starting
Onureg has no boxed warning. Its warnings are the risk of substitution with other azacitidine products, myelosuppression (blood counts are checked every other week for the first 2 cycles and before each later cycle, and the dose is held if neutrophils are below 0.5 Gi/L on day 1), higher toxicity in people with severe liver problems, and harm to an unborn baby[1].
The most common side effects (10% or more) were nausea, vomiting, diarrhea, fatigue, constipation, upper respiratory infection, pneumonia, abdominal pain, joint pain, decreased appetite, febrile neutropenia, dizziness, skin infection and limb pain[1]. An anti-nausea medicine is taken 30 minutes before each dose for at least the first 2 cycles[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Azacitidine (oral)
One 300 mg tablet by mouth once a day, with or without food, on days 1 to 14 of each 28-day cycle, continued until the leukemia returns or side effects become unacceptable[1]. Tablets are swallowed whole. An antiemetic is taken 30 minutes before each dose for the first 2 cycles and can be dropped if there has been no nausea or vomiting[1]. Treatment starts within 4 months of reaching remission in the pivotal trial.
Availability and cost
Only available as the brand-name product.
Help paying for Onureg
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
BMS Access Support Co-Pay Assistance Program for eligible commercially insured patients; the Onureg-specific terms appear only after selecting the medicine on the BMS site. Not for Medicare, Medicaid, TRICARE, VA or other government coverage.
For: private insurance · source - Free medicine program
Bristol Myers Squibb Patient Assistance Foundation provides free medication to eligible uninsured patients experiencing financial hardship. Call 800-736-0003 or visit bmspaf.org.
For: no insurance · source - Insurance and case manager help
BMS Access Support helps with benefits checks, prior authorizations and appeals and refers government-insured patients to independent charitable foundations. Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, no insurance, underinsured · source
Good to know: Onureg.com points patients to BMS Access Support. The co-pay program's Onureg dollar cap was not readable without selecting the medicine on the BMS site.
Access and eligibility
For adults whose AML reached a first complete remission (CR or CRi) after intensive induction chemotherapy and who are not able to complete intensive curative therapy. It is not approved as maintenance after a transplant or after venetoclax-based therapy, and it is not a treatment for active leukemia.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
QUAZAR AML-001 (NCT01757535) randomized 472 people aged 55 or older who were in first complete remission (with or without full count recovery) within 4 months of intensive induction and were not candidates for transplant to Onureg or placebo. Median overall survival was 24.7 months with Onureg against 14.8 months with placebo (hazard ratio 0.69, 95% CI 0.55 to 0.86, p=0.0009)[1][2].
Development history
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Azacitidine (oral)
▸What is Azacitidine (oral) (Onureg)?
A maintenance tablet taken 14 days of every 28 by adults with AML who reached a first complete remission after intensive induction chemotherapy and cannot go on to complete intensive curative treatment such as a transplant. Approved September 1, 2020. It is not interchangeable with injected azacitidine.
▸How does Azacitidine (oral) work?
Like injected azacitidine, the oral form is taken up by dividing cells, built into their DNA and RNA, and blocks DNA methyltransferase so that silenced genes are re-expressed[1]. Taken for 2 weeks of each month after remission, it is meant to suppress the small number of leukemia cells that survive induction and would otherwise cause relapse. The oral tablet gives a lower, longer exposure than the injection, which is why its dose and schedule are different and why the label says the 2 products must never be swapped[1].
▸What are the side effects of Azacitidine (oral)?
Onureg has no boxed warning. Its warnings are the risk of substitution with other azacitidine products, myelosuppression (blood counts are checked every other week for the first 2 cycles and before each later cycle, and the dose is held if neutrophils are below 0.5 Gi/L on day 1), higher toxicity in people with severe liver problems, and harm to an unborn baby[1]. The most common side effects (10% or more) were nausea, vomiting, diarrhea, fatigue, constipation, upper respiratory infection, pneumonia, abdominal pain, joint pain, decreased appetite, febrile neutropenia, dizziness, skin infection and limb pain[1]. An anti-nausea medicine is taken 30 minutes before each dose for at least the first 2 cycles[1].
▸How is Azacitidine (oral) taken?
One 300 mg tablet by mouth once a day, with or without food, on days 1 to 14 of each 28-day cycle, continued until the leukemia returns or side effects become unacceptable[1]. Tablets are swallowed whole. An antiemetic is taken 30 minutes before each dose for the first 2 cycles and can be dropped if there has been no nausea or vomiting[1]. Treatment starts within 4 months of reaching remission in the pivotal trial.
▸Is Azacitidine (oral) FDA approved?
Yes, Azacitidine (oral) (Onureg) is FDA approved (2020) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Celgene Corporation via openFDA · 2026-06-12. Onureg (azacitidine tablets) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%220e95e33f-8aba-4f19-b332-2416580d358b%22
- New England Journal of Medicine · 2020-12-24. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. https://pubmed.ncbi.nlm.nih.gov/33369355/
- FDA. Onureg approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214120