A tolerable, manageable, and predictable safety profile 1

No additional warnings or precautions for VENCLEXTA (venetoclax tablets) were observed in the AML trials.

Adverse reactions reported in ≥30% (any grade)

  • The most common adverse reactions (≥30%) were febrile neutropenia (69%), fatigue (62%), constipation (62%), musculoskeletal pain (54%), dizziness (54%), nausea (54%), abdominal pain (46%), diarrhea (46%), pneumonia (46%), sepsis (excluding fungal; 46%), cough (38%), pyrexia (31%), hypotension (31%), oropharyngeal pain (31%), edema (31%), and vomiting (31%)
  • The most common hematologic laboratory abnormalities (≥30%) were neutrophils decreased (100%), lymphocytes decreased (100%), white blood cells decreased (100%), platelets decreased (92%), hemoglobin decreased (69%)
  • The median duration of exposure for patients taking VEN+DEC was 8.4 months (range: 0.5-39.0 months)

Treatment events and occurrence rates 1

  • Serious adverse reactions were reported in 85% of patients
  • The most frequent serious adverse reactions (≥10%) were sepsis (excluding fungal; 46%), febrile neutropenia (38%), and pneumonia (31%)
  • One (8%) fatal adverse reaction of bacteremia occurred within 30 days of starting treatment
  • Permanent discontinuations due to adverse reactions occurred in 38% of patients
  • The most frequent adverse reaction leading to permanent drug discontinuation (≥5%) was pneumonia (8%)
  • Dosage interruptions due to adverse reactions occurred in 69% of patients
  • The most frequent adverse reactions leading to dose interruption (≥10%) were neutropenia (38%), febrile neutropenia (23%), leukopenia (15%), and pneumonia (15%)
  • Dosage reductions due to adverse reactions occurred in 15% of patients
  • The most frequent adverse reaction leading to dose reduction (≥5%) was neutropenia (15%)

For dose modifications related to drug interactions and management of adverse reactions specific to VEN+DEC regimen, please see section 2 of the full Prescribing Information.

VEN=VENCLEXTA; DEC=decitabine.

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