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Risks of substitution with other azacitidine products1
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 of patients using ONUREG® at the doses recommended for intravenous or subcutaneous azacitidine may not be effective
Do not substitute ONUREG® for intravenous or subcutaneous azacitidine
Myelosuppression1
New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG®, respectively
Febrile neutropenia occurred in 12%
A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively
<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 syndromes1
In AZA-MDS-003 (NCT01566695), 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to myelodysplastic syndromes were randomized to ONUREG® or placebo
107 patients 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 patients who received ONUREG® compared with placebo
The most frequent fatal adverse reaction was sepsis
The safety and effectiveness of ONUREG® for treatment of myelodysplastic syndromes have not been established
Treatment of patients with myelodysplastic syndromes with ONUREG® is not recommended outside of controlled trials
Embryo-fetal toxicity1
Based on the mechanism of action and findings in animals, ONUREG® can cause fetal harm when administered to a pregnant woman
Azacitidine administered to pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m2 basis caused fetal death and anomalies
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
The majority of adverse reactions (ARs) were mild to moderate (Grade 1 or 2) with ONUREG®1
ARs (≥5%) in patients with AML who received ONUREG® with a difference between arms of >2%
compared with placebo in QUAZAR® AML-0011
Assessment of selected hematological abnormalities1
Selected hematological laboratory abnormalities that worsened from baseline in patients who received ONUREG® in QUAZAR® AML-0011
Treatment duration1,2
Select treatment-emergent adverse events (TEAEs) of GI disorders by cycle of onset (cycles 1-24)3