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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.

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Authorized distributors

The following distributors are authorized to sell ONUREG® and are able to service qualified accounts.

Authorized Distributor Network

Community Practices

Cardinal Health Specialty Pharmaceutical Distribution

Phone: 1-877-453-3972

https://specialtyonline.cardinalhealth.com

McKesson Specialty Health

Phone: 1-800-482-6700 Fax: 1-800-289-9285

https://mscs.mckesson.com

Oncology Supply

Phone: 1-800-633-7555 Fax: 1-800-248-8205

https://oncologysupply.com

Specialty Pharmacies and Institutions/Hospital Outpatient Facilities

ASD Healthcare

Phone: 1-800-746-6273 Fax: 1-800-547-9413

https://www.asdhealthcare.com

Cardinal Health Specialty Pharmaceutical Distribution

Phone: 1-866-677-4844 Fax: 1-614-553-6301

https://orderexpress.cardinalhealth.com

McKesson Plasma and Biologics

Phone: 1-877-625-2566 Fax: 1-888-752-7626

https://connect.mckesson.com

Puerto Rico Hospitals and Oncology Clinics

Cardinal Puerto Rico

Phone: 1-787-625-4100 Fax: 1-787-625-4398

https://www.cardinalhealth.pr

Cesar Castillo Inc.

Phone: 1-787-999-1616 Fax: 1-787-999-1618

https://www.facilfarmaciacci.com

AML ICD-10-CM diagnosis codesa

Chart containing the ICD-10-CM codes for adverse reactions. Chart containing the ICD-10-CM codes for adverse reactions.

ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

aThese codes are not all-inclusive.

The information contained herein is not intended to provide specific coding and reimbursement advice for any specific patient or situation. You should check with your coding specialist to ensure appropriate submissions.

Product information

National Drug Codes (NDC) and packaging information

Chart containing the HCPCS and the 10-and-11-digit NDC codes for each ONUREG® dose. Chart containing the HCPCS and the 10-and-11-digit NDC codes for each ONUREG® dose.

aThe red zero converts the 10-digit NDC to the 11-digit NDC. Payer requirements regarding the use of NDCs may vary. Electronic data exchange generally requires use of the 11-digit NDC.

How to order and access ONUREG®

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BMS Access Support®

Patient Access, Reimbursement, and Co-Pay Support

Available Through

Bristol Myers Squibb is committed to helping appropriate patients initiate and maintain access to our medications during the treatment journey. That’s why we created BMS Access Support®, which offers benefit review, prior authorization assistance, and appeal process support, as well as an easy-to-initiate co-pay assistance process and information on financial support. The BMS Access Support Co-pay Assistance Program assists with out-of-pocket co-payment or co-insurance requirements for eligible, commercially insured patients who have been prescribed certain Bristol-Myers Squibb products, including Onureg. For more information, visit BMS Access Support, or call BMS Access Support at 1-800-861-0048, 8 AM to 8 PM ET, Monday-Friday.

Bristol Myers Squibb is committed to helping appropriate patients initiate and maintain access to our medications during the treatment journey. That’s why we created BMS Access Support®, which offers benefit review, prior authorization assistance, and appeal process support, as well as an easy-to-initiate co-pay assistance process and information on financial support. The BMS Access Support Co-pay Assistance Program assists with out-of-pocket co-payment or co-insurance requirements for eligible, commercially insured patients who have been prescribed certain Bristol-Myers Squibb products, including Onureg. For more information, visit BMS Access Support, or call BMS Access Support at 1-800-861-0048, 8 AM to 8 PM ET, Monday-Friday.

Resources

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. Burnett A, Wetzler M, Löwenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011;29(5):487-494.
  3. Büchner T, Berdel WE, Haferlach C, et al. Age-related risk profile and chemotherapy dose response in acute myeloid leukemia: a study by the German Acute Myeloid Leukemia Cooperative Group. J Clin Oncol. 2009;27(1):61-69.
  4. Röllig C, Kramer M, Gabrecht M, et al. Intermediate-dose cytarabine plus mitoxantrone versus standard-dose cytarabine plus daunorubicin for acute myeloid leukemia in elderly patients. Ann Oncol. 2018;29(4):973-978.
  5. Brinda B, Khan I, Parkin B, Konig H. The rocky road to personalized medicine in acute myeloid leukaemia. J Cell Mol Med. 2018;22(3):1411-1427.
  6. SEER Cancer Statistics Review 1975-2017. National Cancer Institute website. https://seer.cancer.gov/csr/1975_2017/. Accessed August 28, 2020.
  7. 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.
  8. ONUREG® [Prescribing Information]. Summit, NJ: Celgene Corporation; 2021.
  9. Sekeres MA, Guyatt G, Abel G, et al. American Society of Hematology 2020 guidelines for treating newly diagnosed acute myeloid leukemia in older adults. Blood Adv. 2020;4(15):3528-3549.
  10. Medeiros BC, 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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 14, 2022. 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.
  12. Döhner H, Weisdorf DJ, Bloomfield CD. Acute myeloid leukemia. New Engl J Med. 2015;373:1136-1152.
  13. Hamadani M, Craig M, Awan FT, Devine SM. How we approach patient evaluation for hematopoietic stem cell transplantation. Bone Marrow Transplant. 2010;45:1259-1268.
  14. Klepin HD, Estey E, Kadia T. More versus less therapy for older adults with acute myeloid leukemia: new perspectives on an old debate. Am Soc Clin Oncol Educ Book. 2019;39:421-432.
  15. Lipof JJ, Loh KP, O’Dwyer K, Liesveld JL. Allogeneic hematopoietic cell transplantation for older adults with acute myeloid leukemia. Cancers (Basel). 2018;10(6):179.
  16. U.S. Food and Drug Administration approves Onureg® (azacitidine tablets), a new oral therapy, as continued treatment for adults in first remission with acute myeloid leukemia [press release]. Bristol Myers Squibb website. https://news.bms.com/news/corporate-financial/2020/U.S.-Food-and-Drug-Administration-Approves-Onureg-azacitidine-tablets-a-New-Oral-Therapy-as-Continued-Treatment-for-Adults-in-First-Remission-with-Acute-Myeloid-Leukemia/default.aspx. Published September 1, 2020. Accessed July 21, 2021.
  17. U.S. Food and Drug Administration approves Onureg® (azacitidine tablets), a new oral therapy, as continued treatment for adults in first remission with acute myeloid leukemia [press release]. Bristol Myers Squibb website. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-onureg-azacitidine-ta. Published September 1, 2020. Accessed September 1, 2020.
  18. 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(Suppl):1-25.
  19. Döhner H, Wei 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.
  20. 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.
  21. Data on file, Celgene Corporation. Summit, New Jersey.
  22. Wei AH, Döhner H, Pocock C, et al. The QUAZAR AML-001 maintenance trial: results of a phase III international, randomized, double-blind, placebo-controlled study of CC-486 in patients with acute myeloid leukemia (AML) in first remission [oral presentation at ASH 2019]. Blood. 2019;134(Suppl 2):LBA-3.
  23. Papaemmanuil E, Gerstung M, Bullinger L, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374(23):2209-2221.
  24. 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.