Onureg FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.
- Onureg is indicated for use in 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.
- Onureg is an oral tablet formulation of azacitidine, which was first approved under the brand name Vidaza (azacitidine for injectable suspension) for the treatment of myelodysplastic syndromes in 2004.
- Onureg cannot be substituted for intravenous or subcutaneous azacitidine as the indications and dosing regimens differ between the oral and injectable formulations.
- Onureg is administered orally once daily on Days 1 through 14 of each 28-day treatment cycle. An antiemetic is administered 30 minutes prior to each dose for at least the first 2 cycles to prevent nausea and vomiting.
- Common adverse reactions (≥ 10%) include nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremities.
Development timeline for Onureg
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