MDS O Tablet

Azacitidine 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. Azacitidine is a nucleoside metabolic inhibitor 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.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Risks of Substitution with Other Azacitidine Products: Do not substitute Azacitidine for intravenous or subcutaneous azacitidine. - 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 Azacitidine based on severity. - Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and use of effective contraception. Risks of Substitution with Other Azacitidine Products Due to substantial differences in the pharmacokinetic parameters, the recommended dose and schedule for Azacitidine are different from those for the intravenous or subcutaneous azacitidine products. Treatment of patients using intravenous or subcutaneous azacitidine at the recommended dosage of Azacitidine may result in a fatal adverse reaction. Treatment of patients using Azacitidine at the doses recommended for intravenous or subcutaneous azacitidine may not be effective. Do not substitute Azacitidine 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 Azacitidine, respectively. Febrile neutropenia occurred in 12%, and sepsis was reported in 6%, including 1 fatal case. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia, respectively. Less than 1% of patients discontinued Azacitidine 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 In AZA-MDS-003 (NCT01566695), 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to myelodysplastic syndromes were randomized to Azacitidine or placebo. One-hundred and seven patients received a median of 5 cycles of Azacitidine 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 Azacitidine compared with placebo. The most frequent fatal adverse reaction was sepsis. The safety and effectiveness of Azacitidine for treatment of myelodysplastic syndromes have not been established. Treatment of patients with myelodysplastic syndromes with Azacitidine is not recommended outside of controlled trials. Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, Azacitidine can cause fetal harm when administered to a pregnant woman. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: - Myelosuppression The most common adverse reactions (≥ 10%) are nausea, vomiting, diarrhea, fatigue/asthenia, constipation, upper respiratory tract infection, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, skin infection, and pain in extremity.. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Acute Myeloid Leukemia The safety of Azacitidine was evaluated in QUAZAR. Patients received Azacitidine 300 mg (N=236) or placebo (N=233) orally once daily on Days 1 through 14 of each 28-day cycle. Among patients who received Azacitidine, 71% were exposed for 6 months or longer, and 49% were exposed for greater than one year. The median duration of exposure to Azacitidine was 11.6 months (range: 0.5 to 74.3 months) and the median number of cycles was 12 (range: 1 to 82 cycles). Serious adverse reactions occurred in 15% of patients who received Azacitidine. Serious adverse reactions in ≥ 2% of patients who received Azacitidine were pneumonia (8%) and febrile neutropenia (7%). One fatal adverse reaction (sepsis) occurred in a patient who received Azacitidine. Permanent discontinuation of Azacitidine due to an adverse reaction occurred in 8% of patients. Adverse reactions which resulted in permanent discontinuation of Azacitidine in > 1% of patients included nausea (2.1%), diarrhea (1.7%), and vomiting (1.3%). Interruptions of Azacitidine due to an adverse reaction occurred in 35% of patients. Adverse reactions which required an interruption of Azacitidine in > 5% of patients included neutropenia (20%), thrombocytopenia (8%), and nausea (6%). Dose reductions of Azacitidine due to an adverse reaction occurred in 14% of patients. Adverse reactions which required a dose reduction in > 1% of patients included neutropenia (6%), diarrhea (3.4%), thrombocytopenia (1.7%), and nausea (1.7%). The most common (≥ 10%) adverse reactions were nausea, vomiting, diarrhea, fatigue/asthenia, constipation, upper respiratory tract infection, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, skin infection, and pain in extremity. Table 2 summarizes the adverse reactions in QUAZAR. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.