This site is intended for U.S. Healthcare Professionals.

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.

This website is best viewed using the horizontal display on your tablet device.

This website is best viewed using the vertical display on your mobile device.

Request a Rep

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

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

NCCN callout
Explore ONUREG Survival Data

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

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

NCCN callout
Explore ONUREG Survival Data

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

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

NCCN callout Explore ONUREG Survival Data

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

Review the Guidelines
ONUREG Clinical Conversations in AML

ONUREG Clinical Conversations

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

Explore the Video Library
Patients should take antiemetics prophylactically with ONUREG

Prophylactic Antiemetics

Patients should take antiemetics prophylactically with ONUREG

Review Dosing Recommendations

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.

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®. Febrile neutropenia occurred in 12%. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia. 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%), pneumonia (27%, 17%), abdominal pain (22%, 13%), arthralgia (14%, 10%), decreased appetite (13%, 6%), febrile neutropenia (12%, 8%), dizziness (11%, 9%), 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®.

References:
  1. ONUREG® [Prescribing Information]. Summit, NJ: Celgene Corporation; 2021.
  2. Cheson BD, Bennett JM, Kopecky KJ, et al. Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003;21(24):4642-4649.
  3. Madeiros BC, Chan SM, Daver NG, et al. Optimizing survival outcomes with post-remission therapy in acute myeloid leukemia. Am J Hematol. 2019;94:803-811.
  4. Röllig C, Bornhäuser M, Thiede C, et al. Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system. J Clin Oncol. 2011;29(20):2758-2765.
  5. Shallis RM, Wang, R, Davidoff A, et al. Epidemiology of acute myeloid leukemia: Recent progress and enduring challenges. Blood Reviews. 2019;36:70-87.
  6. SEER Cancer Statistics. AML 5-year relative survival rates, 2013-2019. seer.cancer.gov/statistics. Accessed January 5, 2023.
  7. Wei AH, Döhner H, Pocock C, et al; QUAZAR AML-001 Trial Investigators. Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission. N Engl J Med. 2020;383(26):2526-2537.
  8. Almeida SN, Elliott R, Silva ER, Sales CMD. Fear of cancer recurrence: a qualitative systematic review and meta-synthesis of patients’ experiences. Clin Psychol Rev. 2019;68:13-24.
  9. Ganguly S, Cortes JE, Krämer A, et al. Clinical outcomes in patients with FLT3-ITD-mutated relapsed/refractory acute myelogenous leukemia undergoing hematopoietic stem cell transplantation after quizartinib or salvage chemotherapy in the QuANTUM-R trial. Transplant Cell Ther. 2021. PMID: 33017662;153-162.
  10. Medeiros BC and Satram S. Real World Treatment Patterns and Comparative Effectiveness among Elderly Patients with Acute Myeloid Leukemia in the United States. Ann Hematol Oncol. 2020;7(1):1283.
  11. Rodríguez-Arbolí E, Márquez-Malaver FJ, Rodríguez-Torres N, et al. Allocation to matched related or unrelated donor results in similar clinical outcomes without increased risk of failure to proceed to transplant among patients with acute myeloid leukemia: a retrospective analysis from the time of transplant approval. Biol Blood Marrow Transplant. 2019;25(1):183-190.
  12. Lai C, Bhansali RS, Kuo EJ, et al. Older adults with newly diagnosed AML: hot topics for the practicing clinician. Am Soc Clin Oncol Educ Book. 2023;43:e390018.
  13. Hamadani M, Craig M, Awan FT, et al. How we approach patient evaluation for hematopoietic stem cell transplantation. Bone Marrow Transplant. 2010;45(8):1259-1268.
  14. Döhner H, Wie AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1345-1377.
  15. Versluis J, Cornelissen JJ. Risks and benefits in a personalized application of allogeneic transplantation in patients with AML in first CR. Semin Hematol. 2019;56(2):164-170.
  16. Servais S, Beguin Y, Baron F. Current status and perspectives of allogeneic hematopoietic stem cell transplantation in elderly patients with acute myeloid leukemia. Stem Cells Transl Med. 2022;11(5):461-477.
  17. Lipof JJ, Loh KP, O’Dwyer K, et al. Allogeneic hematopoietic cell transplantation for older adults with acute myeloid leukemia. Cancers (Basel). 2018;10(6):179.
  18. Blum S, Bacher U, Pabst T. The evolving treatment landscape of AML. Health book TIMES Oncology Hematology. 2022;11(1);32-41.
  19. Cooperrider JH, Shukla N, Nawas MT, Patel AA. The cup runneth over: treatment strategies for newly diagnosed acute myeloid leukemia. JCO Oncol Pract. 2022;19(2):74-85.
  20. Walker AR. How to approach shared decision making when determining consolidation, maintenance therapy, and transplantation in acute myeloid leukemia. Hematology Am Soc Hematol Educ Program. 2020;2020(1):51-56.
  21. ONUREG [Prescribing Information]. Summit, NJ: Celgene Corporation; 2022.
  22. LeBlanc TW, Russell NH, Hernandez-Aldama L, et al. Patient, family member and physician perspectives and experiences with AML treatment decision-making. Oncol Ther. 2022;10(2):421-440.
  23. Crawford R, Sully K, Conroy R, et al. Patient-centered insights on treatment decision making and living with acute myeloid leukemia and other hematologic cancers. Patient. 2020;13(1):83-102.
  24. Austin CA, Mohottige D, Sudore RL, et al. Tools to promote shared decision making in serious illness: a systematic review. JAMA Intern Med. 2015;175(7):1213-1221.
  25. Sommovilla J, Kopecky KE, Campbell T. Discussing prognosis and shared decision-making. Surg Clin N Am. 2019;99:849-858.
  26. 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.
  27. Acute myeloid leukemia: developing drugs and biological products for treatment. Guidance for industry; availability. FDA website. August 2020. Updated October 17, 2022. Accessed September 14, 2023. https://www.fda.gov/media/162362/download.
  28. 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.
  29. Acute myeloid leukemia: developing drugs and biological products for treatment. Guidance for industry; availability. FDA website. August 2020. Updated October 17, 2022. Accessed October 5, 2023. https://www.fda.gov/media/162362/download.
  30. Wei AH, Döhner H, Sayer H, et al. Long-term overall survival (OS) with oral azacitidine (oral-AZA) in patients with acute myeloid leukemia (AML) in first remission after intensive chemotherapy (IC): updated results from the phase 3 QUAZAR AML-001 trial. Abstract presented at: ASH Annual Meeting and Exposition; December 13, 2021
  31. Data on file. BMS-REF-CC-486-0007. Princeton, NJ: Bristol-Myers Squibb Company; 2023
  32. Wei AH, Döhner H, Pocock C, et al. Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission. N Engl J Med. 2020;383(26):2526-2537.
  33. Wei AH, Döhner H, Pocock C, et al; QUAZAR AML-001 Trial Investigators. Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission. Supplementary appendix. N Engl J Med. 2020;383(26):2526-2537.
  34. Döhner H, Wie AH, Roboz GJ, et al. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacytidine. Blood. 2022;140(15):1674-1685.
  35. Data on file. BMS-REF-CC-486-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  36. Data on file. BMS-REF-CC-486-0011. Princeton, NJ: Bristol-Myers Squibb Company; 2023
  37. Data on file. BMS-REF-CC-486-0003. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  38. Data on file. BMS-REF-CC-486-0010. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  39. EQ-5D-3L (About). EQ-5D website. January 11, 2022. Accessed September 14, 2023. https://euroqol.org/eq-5d-instruments/eq-5d-3l-about/.
  40. FACIT-Fatigue. FACIT website. Accessed September 14, 2023. https://www.facit.org/measures/FACIT-Fatigue.
  41. Ravandi F, Roboz GJ, Wei AH, et al. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021;14(1):133.
  42. Data on file. BMS-REF-CC-486-0002. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  43. Data on file. BMS-REF-CC-486-0001. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  44. Lloyd J, Lee CJ. Use of telemedicine in care of hematologic malignancy patients: challenges and opportunities. Curr Hematol Malig Rep. 2022;17(1):25-30
  45. Ravandi F, Roboz GJ, Wei AH, et al. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacytidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021;14:133.
  46. Garcia-Manero G, Santini V, Almeida A, et al. Phase III, randomized, placebo-controlled trial of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes. J Clin Oncol. 2021;39:1426-1436.
  47. Garcia-Manero G, Gore Sd, Kambhampati S, et al. Efficacy and safety of extended dosing schedules of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes. Leukemia. 2016;30:889-896.