Summary of VENCLEXTA™ safety information 1

The safety of single agent VENCLEXTA at the 400-mg recommended daily dose following a dose ramp-up schedule is based on pooled data of 240 patients with previously treated CLL from two phase 2 trials and one phase 1 trial.

Summary of VENCLEXTA safety information-reported adverse reactions in CLL-table
  • The median duration of treatment at the time of data analysis was approximately 10.3 months (range: 0 to 34.1 months). Approximately 46% of patients received VENCLEXTA for more than 48 weeks 1
  • Serious ARs were reported in 43.8% of patients. The most frequent serious ARs (≥2%) were pneumonia (5%), febrile neutropenia (4.6%), pyrexia (3.3%), AIHA (2.9%), anemia (2.1%), and TLS (2.1%) 1,5
  • The most common ARs (≥20%, any grade) were neutropenia (45%), diarrhea (35%), nausea (33%), anemia (29%), upper respiratory tract infection (22%), thrombocytopenia (22%), and fatigue (21%) 1
  • Discontinuations due to ARs occurred in 8.3% of patients. The most frequent adverse reactions leading to drug discontinuation were thrombocytopenia and AIHA 1
  • Dosage adjustments due to ARs occurred in 9.6% of patients. The most frequent adverse reactions leading to dosage adjustments were neutropenia, febrile neutropenia, and thrombocytopenia 1
  • A trend for increased adverse events was observed in patients with moderate hepatic impairment; monitor these patients more closely for signs of toxicity during the initiation and dose ramp-up phase 1

AIHA=autoimmune hemolytic anemia.