Notes on venetoclax

Notes on venetoclax

1. Tumor lysis syndrome

(1) Patients with high tumor burden reported the occurrence of tumor lysis syndrome, including fatal events and renal failure requiring dialysis, when receiving treatment with this product.

There is a risk of tumor lysis syndrome during the initial dosing and escalation periods, and patients need to be risk assessed and treated with appropriate prophylaxis.

(2) During the initial dosing and escalation period, the concomitant use of this product with P-gp inhibitors or strong or moderate CYP3A inhibitors will increase the exposure of this product and may increase the risk of tumor lysis syndrome.

When combined with strong or moderate CYP3A inhibitors or P-gp inhibitors, the dose of this product should be reduced.

2. Neutropenia

In patients treated with this product combined with azacitidine, 98% ~ 100% of patients will have a reduced neutrophil count compared with baseline, and neutropenia may recur in the subsequent course of treatment.

A complete blood count should be monitored throughout the treatment period, and supportive measures, including anti-infective therapy and the use of growth factors, are recommended in the event of severe neutropenia.

3. Infection

Fatal and serious infections, such as pneumonia and sepsis, have occurred in patients treated with this product.

Patients need to be closely monitored for signs and symptoms of infection and treated promptly.

In the event of grade 3 and 4 infection, treatment with this product should be discontinued until recovery.

4. Immunization

Live attenuated vaccine should not be administered before, during, and after treatment with this product, and before B cell recovery is made.

The safety and efficacy of live attenuated vaccine administration during or after treatment with this product have not been studied.

Patients should be advised that vaccination may not respond well.

5. Embryo-fetal toxicity

Pregnant women taking this product may cause embryo-fetal toxicity.

Pregnant women should be informed of the potential harm of venetoclax to the fetus.

Women of childbearing potential are advised to avoid pregnancy during treatment with this product and for at least 30 days after the last dose.

6. The addition of venetoclax on the basis of bortezomib and dexamethasone in the treatment of multiple myeloma patients causes increased mortality

Outside of well-managed clinical trials, the combination of venetoclax with bortezomib + dexamethasone is not recommended for the treatment of patients with multiple myeloma.