Venetoclax Tablets 10 mg (Venetoclax)

Adult dosage

This medicine should be taken once daily at the same time with food and water. Swallow this medicine whole; do not chew, crush, or break it into pieces before swallowing. Chronic lymphocytic leukemia Treatment with this medicine should be initiated at 20 mg once daily for 7 days, followed by weekly dose escalation over 5 weeks according to the doses of this medicine presented in Table 1, until a daily dose of 400 mg is reached. Week 1: 20mg Week 2: 50mg Week 3: 100mg Week 4: 200mg Week 5: 400mg Combination with obinutuzumab This medicine is administered for a total of 12 cycles: 6 cycles in combination with obinutuzumab, followed by 6 cycles of this medicine alone. Obinutuzumab is administered at 100mg on Day 1 of Cycle 1, followed by 900mg on Day 1 (consecutively) or Day 2. A dose of 1000mg is administered on Days 8 and 15 of Cycle 1 and on Day 1 of each of the following five cycles (a total of 6 cycles, each consisting of 28 days). This medicine is administered according to the dose-escalation schedule from Day 22 of Cycle 1 through Day 28 of Cycle 2 (see Table 1). After completion of the dose-escalation schedule, administer 400mg of this medicine once daily from Day 1 of Cycle 3 of obinutuzumab administration through Cycle 12. Combination with rituximab After completing 7 days of treatment with this medicine at 400mg according to its dose-escalation schedule (Table 1), initiate rituximab. Rituximab is administered on Day 1 of each cycle for a total of 6 cycles (1 cycle = 28 days): 375mg/m2 on Day 1 of the first cycle, and 500mg/m2 on Day 1 of each cycle from the second through sixth cycles. Continue treatment with 400mg of this medicine once daily for 24 months, starting on Day 1 of the first treatment cycle of rituximab. Monotherapy The recommended maintenance dose of this medicine is 400mg once daily after completion of the 5-week dose-escalation schedule (Table 1). This medicine should be administered orally once daily until disease progression or unacceptable toxicity is observed. Acute myeloid leukemia Day 1: 100mg Day 2: 200mg Day 3: 400mg Day 4 and thereafter: 400mg When administered in combination with azacitidine or decitabine This medicine is initiated on Day 1 of Cycle 1 together with azacitidine or decitabine. Azacitidine should be administered intravenously or subcutaneously at 75mg/m2 on Days 1-7 of each 28-day cycle. Decitabine should be administered intravenously at 20mg/m2 on Days 1-5 of each 28-day cycle. When this medicine is administered in combination with azacitidine or decitabine, treatment should continue until disease progression or unacceptable toxicity is observed. Missed dose If the patient realizes that a dose was missed within 8 hours of the scheduled administration time, take the missed dose as soon as possible and resume the usual daily dosing schedule. If more than 8 hours have elapsed since the missed dose, do not take the missed dose; resume the usual daily dosing schedule the following day. If the patient vomits after taking a dose, do not take an additional dose on the same day. Take the next prescribed dose at the usual time. Initiate allopurinol or a xanthine oxidase inhibitor 2-3 days before starting this medicine. Low tumor burden: oral intake (1.5-2 L) Medium tumor burden: oral intake (1.5-2 L) and consider additional intravenous fluids High tumor burden: oral intake (1.5-2 L) and intravenous fluids (150-200 mL/hour if possible) First 20 mg and 50 mg doses: before administration, 6-8 hours, 24 hours. Dose-escalation phase: before administration. First 20 mg and 50 mg doses: consider hospitalization for patients with CLcr <80ml/min; if hospitalized, refer to the monitoring below. First 20 mg and 50 mg doses: before administration, 4, 8, 12, 24 hours. Dose-escalation phase: before administration, 6-8 hours, 24 hours. The daily dose-escalation period for this medicine is 3 days when used in combination with azacitidine or decitabine. Monitor blood chemistry values for TLS before administration, 6-8 hours after each new dose administered during the dose-escalation period, and 24 hours after reaching the final dose. Initiate treatment at a reduced dose: Dose at interruption 400mg: restart dose 300mg Dose at interruption 300mg: restart dose 200mg Dose at interruption 200mg: restart dose 100mg Dose at interruption 100mg: restart dose 50mg Dose at interruption 50mg: restart dose 20mg Dose at interruption 20mg: restart dose 10mg Continue at the reduced dose for 1 week before increasing the dose. First occurrence: Once the toxicity has resolved to Grade 1 or 2, resume this medicine in combination with azacitidine or decitabine at the same dose. Subsequent occurrence: Once the toxicity has resolved to Grade 1 or 2, resume this medicine in combination with azacitidine or decitabine at the same dose, and shorten the duration of this medicine by 7 days during each subsequent cycle (i.e., 21 days instead of 28 days). Concomitant use of this medicine with strong or moderate CYP3A inhibitors, or P-gp inhibitors, increases exposure to this medicine (i.e., Cmax and AUC) and may increase the risk of TLS at treatment initiation and during the dose-escalation period. In patients with chronic lymphocytic leukemia, this medicine must not be coadministered with strong CYP3A inhibitors at treatment initiation and during the dose-escalation period. Resume this medicine 2-3 days after discontinuing the CYP3A inhibitor or P-gp inhibitor, at the dose used before starting concomitant treatment with the CYP3A inhibitor or P-gp inhibitor. Strong CYP3A inhibitor, chronic lymphocytic leukemia: contraindicated Strong CYP3A inhibitor, acute myeloid leukemia: Day 1 – 10mg; Day 2 – 20mg; Day 3 – 50mg; Day 4 – 100mg or less Strong CYP3A inhibitor, daily dose after the dose-escalation period: reduce the dose of this medicine to 100mg or less Moderate CYP3A inhibitor: reduce the dose of this medicine by at least 50% P-gp inhibitor: reduce the dose of this medicine by at least 50%

This drug can cause serious side effects known as tumor lysis syndrome, which can occur as the tumor rapidly shrinks. This syndrome can cause electrolyte imbalances in the blood and impaired kidney function; therefore, special care is needed when initiating treatment and during dosage increases. Before administration, it is crucial to thoroughly assess the tumor burden and kidney function of the patient and to take preventive measures using medications to lower uric acid levels, along with adequate hydration. Blood tests should be conducted frequently to monitor for abnormal values, and immediate action should be taken if abnormalities are detected. This medication may reduce the number of neutrophils among white blood cells, increasing the risk of infections. If neutropenia is severe, drug administration may need to be halted or the dosage reduced, and treatment to prevent infections should also be considered. Moreover, serious infections such as pneumonia or sepsis may occur, so careful observation of the patient for fever or infection symptoms is essential, and prompt treatment should be administered if necessary, and drug administration may be suspended. During or after treatment, live vaccinations should be avoided, and this drug should not be administered to pregnant women. Women of childbearing potential must take a pregnancy test before starting treatment, and effective contraception must be maintained during and for at least 30 days after treatment. The risk of side effects may be heightened in patients with impaired liver and kidney function, so these patients require special attention. They should discuss dosage adjustment or treatment methods with their healthcare provider. When this medication is used in conjunction with certain antifungals, antibiotics, or other various drugs, the blood concentration of this drug may change, so it is vital to inform healthcare professionals about concomitant medications, and periodic monitoring is needed during treatment. This drug's safety and efficacy in children have not been established, and special caution is needed for the elderly, although no significant differences by age have been reported in clinical trials. In the event of an overdose, there is no antidote available, so it is essential to visit a medical institution immediately for appropriate treatment and monitoring, and this drug is difficult to remove by dialysis. Finally, this medication may cause fatigue, so caution is needed when driving or operating machinery. This drug should be stored out of reach of children and kept in a cool place below 30 degrees Celsius.

• Tumor lysis syndrome
• neutropenia
• pneumonia
• sepsis
• febrile neutropenia
• anemia
• diarrhea
• nausea
• constipation
• vomiting

This drug is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is best to keep the medication at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for an extended period.

Appearance

Biconvex, round, film-coated tablets that are light yellow with 'V' on one side and '10' on the other side.

Package unit

14 tablets/box [14 tablets/PTP*1]