Active Ingredient: Venetoclax
Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in combination with acalabrutinib with or without obinutuzumab.
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 14 :
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.
Treatment with venetoclax in combination with acalabrutinib with or without obinutuzumab should continue until disease progression, unacceptable toxicity or completion of 14 cycles (each cycle is 28 days).
Administer acalabrutinib 100 mg orally on Cycle 1 Day 1 approximately every 12 hours for a total of 14 cycles of treatment. Each cycle is 28 days.
Start the 5-week venetoclax dose-titration schedule (Table 1) on Cycle 3 Day 1. After completing the dose-titration schedule, the recommended dose of venetoclax is 400 mg once daily until the last day of Cycle 14.
If venetoclax is given in combination with acalabrutinib and obinutuzumab, administer obinutuzumab 100 mg on Cycle 2 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 2 and on Day 1 of Cycles 3 to 7. Obinutuzumab is administered for a total of 6 cycles.
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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