Active Ingredient: Venetoclax
Venetoclax in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Venetoclax in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Venetoclax monotherapy is indicated for the treatment of CLL:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 20 milligrams venetoclax, once daily to meals, over the duration of 1 week. Afterwards, oral, 50 milligrams venetoclax, once daily to meals, over the duration of 1 week. Afterwards, oral, 100 milligrams venetoclax, once daily to meals, over the duration of 1 week. Afterwards, oral, 200 milligrams venetoclax, once daily to meals, over the duration of 1 week. Afterwards, oral, 400 milligrams venetoclax, once daily to meals.
The starting dose is 20 mg of venetoclax once daily for 7 days. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg as shown in Table 1.
Table 1. Dose increase schedule in patients with CLL:
| Week | Venetoclax daily dose |
|---|---|
| 1 | 20 mg |
| 2 | 50 mg |
| 3 | 100 mg |
| 4 | 200 mg |
| 5 | 400 mg |
The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of TLS.
Venetoclax is given for a total of 12 cycles, each cycle consisting of 28 days: 6 cycles in combination with obinutuzumab, followed by 6 cycles of venetoclax as a single agent.
Administer obinutuzumab 100 mg on Cycle 1 Day 1, followed by 900 mg which may be administered on Day 1 or Day 2. Administer 1000 mg on Days 8 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle, for a total of 6 cycles.
Start the 5-week venetoclax dose-titration schedule (see Table 1) on Cycle 1 Day 22 and continue through Cycle 2 Day 28.
After completing the dose-titration schedule, the recommended dose of venetoclax is 400 mg once daily from Cycle 3 Day 1 of obinutuzumab to the last day of Cycle 12.
The recommended dose of venetoclax in combination with rituximab is 400 mg once daily.
Administer rituximab after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg venetoclax for 7 days.
Venetoclax is taken for 24 months from Cycle 1 Day 1 of rituximab.
The recommended dose of venetoclax is 400 mg once daily. Treatment is continued until disease progression or no longer tolerated by the patient.
If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day. If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.
If a patient vomits following dosing, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time the following day.
It should be taken with a meal.
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax.
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