Skip to main content
Menu

Remission
is not the
destination,
it’s the starting point.

With ONUREG®, help your patients with AML
live longer1,a

ONUREG is indicated for continued treatment of adults with AML in first CR or CRi following intensive induction chemotherapy who are unable to complete intensive curative therapy.1
Clinical Guidelines

Clinical Guidelines

Oral azacitidine (ONUREG) is the ONLY NCCN Category 1 preferred National Comprehensive Cancer Network® (NCCN®) maintenance treatment option across all risk categories2,b

ONUREG Clinical Conversations in AML

ONUREG Clinical Conversations

Listen to experts discuss the pivotal QUAZAR® AML-001 trial of ONUREG

Patients should take antiemetics prophylactically with ONUREG

Prophylactic Antiemetics

Patients should take antiemetics prophylactically with ONUREG

aQUAZAR® AML-0011
The efficacy of ONUREG (azacitidine) was evaluated in QUAZAR AML-001, a multicenter, randomized, double-blind, placebo-controlled, phase III study. Eligible patients were aged 55 years or older, had AML, and were within 4 months of achieving first CR/CRi with intensive chemotherapy. Patients were excluded if they were candidates for HSCT at the time of screening. A total of 472 patients, who completed induction with or without consolidation therapy, were randomized 1:1 to receive ONUREG 300 mg (n=238) or placebo (n=234) orally on Days 1 through 14 of each 28-day treatment cycle. Efficacy was established based on OS. ONUREG demonstrated a statistically significant improvement in median OS compared with placebo: 24.7 months (95% CI: 18.7, 30.5) vs 14.8 months (95% CI: 11.7, 17.6), respectively (HR: 0.69 [95% CI: 0.55, 0.86; P=0.0009]).1

bNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2
Category 1 Preferred recommendation applies to patients in the maintenance setting with favorable, intermediate, or adverse risk non-CBF AML that are aged ≥55 (category 2A for other age groups) and who have received prior intensive chemotherapy and whose disease is now in remission; completed no consolidation, some consolidation or a recommended course of consolidation; and for whom no allogeneic HCT is planned.2

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia Version 2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 26, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

The definition of continued and maintenance treatment by the FDA and NCCN differ based on the AML treatment period in patients with or without CR.2,3
AML, acute myeloid leukemia; CBF, core binding factor; CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete blood count recovery; FDA, Food and Drug Administration; HCT, hematopoietic cell transplantation; HR, hazard ratio; HSCT, hematopoietic stem cell transplantation; NCCN, National Comprehensive Cancer Network® (NCCN®); OS, overall survival.

References

INDICATION

ONUREG® is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONUREG® is contraindicated in patients with known severe hypersensitivity to azacitidine or its components.

WARNINGS AND PRECAUTIONS

Risks of Substitution with Other Azacitidine Products

Due to substantial differences in the pharmacokinetic parameters, the recommended dose and schedule for ONUREG® are different from those for the intravenous or subcutaneous azacitidine products. Treatment of patients using intravenous or subcutaneous azacitidine at the recommended dosage of ONUREG® may result in a fatal adverse reaction. Treatment with ONUREG® at the doses recommended for intravenous or subcutaneous azacitidine may not be effective. Do not substitute ONUREG® for intravenous or subcutaneous azacitidine.

Myelosuppression

New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG®, respectively. Febrile neutropenia occurred in 12%, and sepsis was reported in 6%, including 1 fatal case. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively. Less than 1% of patients discontinued ONUREG® due to either neutropenia or thrombocytopenia. Monitor complete blood counts and modify the dosage as recommended. Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs.

Increased Early Mortality in Patients with Myelodysplastic Syndromes (MDS)

In AZA-MDS-003, 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to MDS were randomized to ONUREG® or placebo. 107 received a median of 5 cycles of ONUREG® 300 mg daily for 21 days of a 28-day cycle. Enrollment was discontinued early due to a higher incidence of early fatal and/or serious adverse reactions in the ONUREG® arm compared with placebo. The most frequent fatal adverse reaction was sepsis. Safety and effectiveness of ONUREG® for MDS have not been established. Treatment of MDS with ONUREG® is not recommended outside of controlled trials.

Embryo-Fetal Toxicity

ONUREG® can cause fetal harm when administered to a pregnant woman. Azacitidine caused fetal death and anomalies in pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m2 basis. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ONUREG® and for at least 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ONUREG® and for at least 3 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 15% of patients who received ONUREG®. Serious adverse reactions in ≥2% included pneumonia (8%) and febrile neutropenia (7%). One fatal adverse reaction (sepsis) occurred in a patient who received ONUREG®.

Most common (≥10%) adverse reactions with ONUREG® vs placebo were nausea (65%, 24%), vomiting (60%, 10%), diarrhea (50%, 21%), fatigue/asthenia (44%, 25%), constipation (39%, 24%), upper respiratory tract infection (34%, 28%), pneumonia (27%, 17%), abdominal pain (22%, 13%), arthralgia (14%, 10%), decreased appetite (13%, 6%), febrile neutropenia (12%, 8%), dizziness (11%, 9%), skin infection (11%, 8%), and pain in extremity (11%, 5%).

LACTATION

There are no data regarding the presence of azacitidine in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ONUREG® and for 1 week after the last dose.

Please see full Prescribing Information for ONUREG®.

Important Safety Information  |  Full Prescribing Information   |  Contact Us  |  Privacy Policy  |   Your Privacy Choices  |  Terms of Use  

© 2026 Bristol-Myers Squibb Company.
ONUREG® is a registered trademark of Celgene Corporation, a Bristol Myers Squibb Company.
Access Support® is a registered trademark of Bristol Myers Squibb Company.
2011-US-2500015 08/26