Active Ingredient: Venetoclax
Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in combination with ibrutinib.
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.
Until cycle 15 :
Oral, 400 milligrams venetoclax, once daily.
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.
Start ibrutinib (420 mg once daily) as a single agent for 3 cycles (1 cycle is 28 days), followed by 12 cycles of venetoclax in combination with ibrutinib. Beginning on Cycle 4 Day 1, administer venetoclax according to the dose-titration schedule (see Table 1). After completing the dose-titration schedule, patients should continue venetoclax 400 mg once daily in combination with ibrutinib 420 mg orally once daily to the last day of Cycle 15.
Refer to the ibrutinib Summary of Product Characteristics for additional information.
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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