Active Ingredient: Venetoclax
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 20 milligrams venetoclax, once daily, over the duration of 1 week. Afterwards, oral, 50 milligrams venetoclax, once daily, over the duration of 1 week. Afterwards, oral, 100 milligrams venetoclax, once daily, over the duration of 1 week. Afterwards, oral, 200 milligrams venetoclax, once daily, over the duration of 1 week. Afterwards, oral, 400 milligrams venetoclax, once daily, over the duration of 1 week. Afterwards, oral, 400 milligrams venetoclax, once daily, over the duration of 24 months.
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.
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.
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.
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax.
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