ONUREX 300 mg (Azacitidine)

Adult dose

Treatment with this medicine should be initiated and monitored by a physician experienced in the use of anticancer chemotherapy. Due to differences in exposure, dosage, and administration schedule, this medicine should not be substituted for injectable azacitidine. Verify the product name, dose, and route of administration. 1. Instructions for use This medicine should be swallowed whole with water at approximately the same time each day. The tablets should not be split, crushed, dissolved, or chewed. This medicine may be administered with or without food (see ‘14. Precautions for storage and handling’). 2. Recommended dose and administration schedule Patients should receive an antiemetic 30 minutes before administration of this medicine during the first 2 cycles. If nausea and vomiting do not occur during the first 2 cycles, antiemetic prophylaxis may be omitted thereafter (see ‘5. General precautions’). The recommended dose is azacitidine 300 mg orally once daily. Each repeated cycle consists of a 14-day treatment period followed by a 14-day rest period (28-day treatment cycle). Administration of this medicine should continue until 15% or fewer blasts are observed in peripheral blood or bone marrow, or unacceptable toxicity occurs. 3. Laboratory tests A complete blood count should be performed before starting treatment. Monitoring should be performed every 2 weeks during the first 2 cycles (56 days) after treatment initiation and dose adjustment, and monthly thereafter (before the start of each subsequent treatment cycle) (see ‘5. General precautions’). If the absolute neutrophil count is less than 0.5 × 109/L on Day 1 of a cycle, do not administer this medicine. Delay the start of the cycle until the absolute neutrophil count is at least 0.5 × 109/L. 4. Dose schedule adjustment for relapse of acute myeloid leukemia For disease relapse, with clinical assessment, when 5%~15% blasts are present in peripheral blood or bone marrow, extending the administration schedule from 14 days to 21 days during repeated 28-day cycles should be considered. Administration should not exceed 21 days within a 28-day period. This medicine should be discontinued if 15% or more blasts are observed in peripheral blood or bone marrow, or if the physician considers discontinuation necessary. 5. Dose adjustment for adverse reactions Dose adjustment guidelines for hematologic and nonhematologic adverse reactions are recommended based on clinical and laboratory findings (see Table 1). Table 1. Dose adjustment for hematologic and nonhematologic adverse reactions Criteria* Recommended action Grade 4 neutropenia or Grade 3 neutropenia with fever First occurrence •Discontinue this medicine. When neutropenia recovers to Grade 2 or lower, resume the treatment cycle at the same dose. •Use supportive care, such as granulocyte colony-stimulating factor (GCSF), if clinically necessary (see ‘5. General precautions’). Occurrence in 2 consecutive cycles •Discontinue this medicine. When neutropenia recovers to Grade 2 or lower, resume the treatment cycle at the reduced dose of 200 mg. •If the patient continues to experience toxicity after dose reduction, shorten the treatment duration to 7 days. •If toxicity persists or recurs after dose reduction and schedule shortening, discontinue this medicine. •Use supportive care, such as granulocyte colony-stimulating factor (GCSF), if clinically necessary (see ‘5. General precautions’). Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding First occurrence •Discontinue this medicine. When thrombocytopenia recovers to Grade 2 or lower, resume the treatment cycle at the same dose. Occurrence in 2 consecutive cycles •Discontinue this medicine. When thrombocytopenia recovers to Grade 2 or lower, resume the treatment cycle at the reduced dose of 200 mg. •If the patient continues to experience toxicity after dose reduction, shorten the treatment duration to 7 days. •If toxicity persists or recurs after dose reduction and schedule shortening, discontinue this medicine. Grade 3 or higher nausea, vomiting, or diarrhea •Discontinue this medicine. When toxicity recovers to Grade 1 or lower, resume the treatment cycle at the same dose. •Use supportive care, such as antiemetics and antidiarrheals, if symptoms occur (see ‘5. General precautions’). •If symptoms recur, withhold treatment until recovery to Grade 1 or lower, then resume at a dose of 200 mg. •If the patient continues to experience toxicity after dose reduction, shorten the treatment duration to 7 days. •If toxicity persists or recurs after dose reduction and schedule shortening, discontinue this medicine. Other Grade 3 or higher nonhematologic events •Discontinue this medicine and provide medical support in accordance with local recommendations. When toxicity recovers to Grade 1 or lower, resume the treatment cycle at the same dose. •If toxicity recurs, discontinue this medicine until recovery to Grade 1 or lower, then resume at the reduced dose of 200 mg. •If the patient continues to experience toxicity after dose reduction, shorten the treatment duration to 7 days. •If toxicity persists or recurs after dose reduction and schedule shortening, discontinue this medicine. * Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, and Grade 4 is life-threatening. Toxicity grades are based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.3 (NCI-CTCAE v4.3). 6. Missed or delayed doses If a dose of this medicine is missed or is not taken at the usual time, take it as soon as possible on the same day. Thereafter, take the next scheduled dose at the original time on the following day. Do not take 2 doses on the same day. If the medicine is vomited, do not take another dose of this medicine on the same day. Instead, take it at the original time on the following day.

This drug can cause serious harm to the fetus if administered to pregnant women; therefore, women of childbearing potential must use effective contraception during and for at least 6 months after taking this medication. Male patients must also ensure that their partner does not become pregnant during treatment and for at least 3 months after stopping the drug. Patients who are allergic to any active ingredient or component of this drug, as well as those with genetic lactose intolerance or lactating women, should not take this medication. Patients with kidney or liver dysfunction must use this medication with caution, and dosage adjustments may be necessary under a doctor's guidance. Blood-related side effects such as neutropenia and thrombocytopenia may occur frequently, making blood tests and monitoring of symptoms important. Gastrointestinal and systemic side effects such as nausea, vomiting, diarrhea, fatigue, and pneumonia may occur, so report any symptoms immediately to healthcare professionals. During the treatment, the risk of infection may increase; prompt treatment is necessary if fever or symptoms of infection appear. Use of this medication is not recommended during pregnancy or breastfeeding, especially as it may pass into breast milk and affect the baby. This medication may cause fatigue, so caution is advised when driving or operating machinery. There is no specific antidote for overdose; immediate medical attention for proper monitoring and supportive care is required. This medication is cytotoxic; handle it with care to avoid contact with skin or mucous membranes, and wash immediately if contact occurs.

• Pneumonia
• febrile neutropenia
• sepsis
• nausea
• diarrhea
• vomiting
• fatigue
• weakness
• constipation
• abdominal pain

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best to store it at room temperature between 1 degree and 30 degrees Celsius. This helps maintain the drug’s efficacy over time.

Appearance

Brown oval film-coated tablet imprinted with '300' on one side and 'ONU' on the other side.

Package unit

7 tablets/box [7 tablets/blister X 1]