What is the usage and dosage in the instructions for venetoclax/venetoclax?

Venetoclax/Venetoclax is an oral medication available in three strengths (10, 50 and 100 mg) in tablet form and is recommended to be taken with water and meals at approximately the same time each day. The dosing regimen of venetoclax depends on the condition being treated. In cases of chronic lymphocytic leukemia (CLL), it involves a gradual increase over 5 weeks. In cases of acute myeloid leukemia (AML), the dose is increased daily over 4 days with azacitidine, decitabine, or low-dose cytarabine on day 1.

For patients with CLL, the daily oral dose is 20 mg in the first week, 50 mg in the second week, 100 mg in the third week, 200 mg in the fourth week, and 400 mg in the fifth week and beyond until unacceptable toxicity or malignancy progression occurs. The purpose of weekly dose escalation is to reduce and reduce the risk of tumor lysis syndrome (TLS).

For AML patients, the oral dose is 100 mg on the first day, 200 mg on the second day, 400 mg on the third day, 400 mg when combined with azacitidine or decitabine on the fourth day and beyond; and 600 mg when combined with low-dose cytarabine.

The dose of venetoclax was determined by studies showing that the steady-state venetoclax AUC (area under the curve) increased proportionally from 150 to 800 mg; taking venetoclax with a low-fat or high-fat meal increased drug exposure by 3.4-fold to 5.3-fold, respectively. Dose reduction is sometimes necessary when toxicity-related toxicities occur (eg, TLS, hematological toxicities such as grade 3 neutropenia, and/or grade 3/4 non-hematological toxicities).