Onureg

Azacitidine

• Brand(s): Onureg
• Dosage Form/Strength: 200 mg, 300 mg tablet
• Updated: November 14, 2022

Initiation Criteria:

For maintenance treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) following induction therapy with or without consolidation therapy in patients who meet ALL the following criteria:

1. 18 years of age or older; AND

2. Has newly diagnosed AML (de novo or secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)) with intermediate- or poor-risk cytogenetics; AND

3. Ineligible for hematopoietic stem cell transplant (HSCT); AND

4. Patient is in first remission with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation chemotherapy; AND

5. Has Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3; AND

6. Has adequate organ function; AND

7. Prescribed by a clinician with expertise in the diagnosis and treatment of AML.

Notes:

1. Oral azacitidine should be started within 4 months of achieving CR or CRi.

2. Patients with FMS-Like Tyrosine Kinase 3 (FLT3) mutation positive AML meeting the initiation criteria can be funded.

3. If the ANC is less than 500/mcL on Day 1 of a cycle, oral azacitidine should not be administered and the start of the cycle should be delayed until the ANC is 500/mcLor more.

Discontinuation criteria:

Oral azacitidine should be discontinued upon the occurrence of any of the following:

• Disease relapse (i.e., appearance of >5% blasts in the bone marrow or peripheral blood)
• Unacceptable toxicity
• Patient becomes eligible (at the discretion of the treating clinician) for allogeneic bone marrow or stem cell transplantation during the treatment period

Exclusion Criteria

• Patients who are eligible for HSCT are not funded.
• Patients with favourable risk genetics.
• Maintenance following re-induction/re-consolidation in relapsed AML will not be funded.

Renewal Criteria

Renewal of funding will be considered for patient who do not meet any of the discontinuation criteria or exclusion criteria.

Lab reports to confirm that the patient has not relapsed must be submitted.

Approved Dose: Up to 300 mg orally once daily on Days 1 through 14 with each 28-days cycle.

Note that dose escalations to reinitiate remission in those experiencing a disease relapse will not be funded.

Approval duration (Initials and Renewals): 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests