Precautions of Venetoclax

1.Tumor Lysis Syndrome

Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients treated with venetoclax.

2.Neutropenia

In patients with CLL, Grade 3 or 4 neutropenia developed in 63% to 64% of patients and Grade 4 neutropenia developed in 31% to 33% of patients when treated with venetoclax in combination and monotherapy studies. Febrile neutropenia occurred in 4% to 6% of patients.

3.Infections

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

4.Immunization

Do not administer live attenuated vaccines prior to, during, or after treatment with venetoclax until B-cell recovery occurs. The safety and efficacy of immunization with live attenuated vaccines during or following venetoclax therapy have not been studied. Advise patients that vaccinations may be less effective.

5.Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, venetoclax may cause embryofetal harm when administered to a pregnant woman. In an embryo-fetal study conducted in mice, administration of venetoclax to pregnant animals at exposures equivalent to that observed in patients at a dose of 400 mg daily resulted in post-implantation loss and decreased fetal weight.

6.Increased Mortality in Patients with Multiple Myeloma when venetoclax is Added
to Bortezomib and Dexamethasone

In a randomized trial (BELLINI; NCT02755597) in patients with relapsed or refractory multiple myeloma, the addition of venetoclax to bortezomib plus dexamethasone, a use for which venetoclax is not indicated, resulted in increased mortality. Treatment of patients with multiple myeloma with venetoclax in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.

from FDA，2022.06