Active Ingredient: Venetoclax
Venetoclax in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 100 milligrams venetoclax, once daily, over the duration of 1 day. Afterwards, oral, 200 milligrams venetoclax, once daily, over the duration of 1 day. Afterwards, oral, 400 milligrams venetoclax, once daily.
The recommended venetoclax dosing schedule (including dose-titration) is shown in Table 1.
Table 1. Dose increase schedule in patients with AML:
| Day | Venetoclax daily dose |
|---|---|
| 1 | 100 mg |
| 2 | 200 mg |
| 3 and beyond | 400 mg |
Azacitidine should be administered at 75 mg/m² of body surface area (BSA) either intravenously or subcutaneously on Days 1-7 of each 28-day cycle beginning on Cycle 1 Day 1.
Decitabine should be administered at 20 mg/m² of BSA intravenously on Days 1-5 of each 28-day cycle beginning on Cycle 1 Day 1.
Venetoclax dosing may be interrupted as needed for management of hematologic toxicities and blood count recovery.
Venetoclax, in combination with a hypomethylating agent, should be continued until disease progression or unacceptable toxicity is observed.
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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