ONUREG

The systemic exposure of azacitidine is approximately dose proportional over the dose range of 120 mg to 600 mg once daily of ONUREG (0.4 to 2 times the recommended dosage). Following a single 300 mg dose of ONUREG, the mean (coefficient of variation [CV%]) C max of azacitidine was 145 ng/mL (64%) and the mean AUC of azacitidine was 242 ng h/mL (65%). No accumulation was observed following ONUREG 300 mg once daily.

AbsorptionThe mean oral bioavailability is approximately 11% relative to subcuta...

The efficacy of ONUREG was evaluated in QUAZAR (NCT01757535), a multicenter, randomized, double-blind, placebo-controlled study. Eligible patients were ages 55 years or older, had AML, and were within 4 months of achieving first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) with intensive induction chemotherapy. Patients may have received consolidation (see Table 4 ). Patients were excluded if they were candidates for hematopoietic stem cell transplantation at the time of screening. A total of 472 patients who completed induction with or without conso...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Myelosuppression [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥ 10%) are nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremity ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb Company at 1-800-721-5072 or FDA at 1-800-FDA-1088 or...

ONUREG is contraindicated in patients with known severe hypersensitivity to azacitidine or its components [see Adverse Reactions (6.2) , Description (11) ] . History of severe hypersensitivity to azacitidine or its components ( 4 ).

• Risks of Substitution with Other Azacitidine Products : Do not substitute ONUREG for intravenous or subcutaneous azacitidine ( 2.1 , 5.1 ).
• Myelosuppression : Monitor complete blood counts every other week for the first 2 cycles and prior to the start of each cycle thereafter. Increase monitoring to every other week for the 2 cycles after any dose reduction. Withhold and then resume at same or reduced dose or discontinue ONUREG based on severity ( 2.3 , 5.2 ).
• Embryo-Fetal Toxicity : Can c...