A tolerable, manageable, and predictable safety profile 1

No additional warnings or precautions for VENCLEXTA were observed in the AML trials.

Adverse reactions (≥10%) in patients with AML who received VEN+LDAC with a difference between arms of ≥5% for all grades or ≥2% for Grade 3 or 4 reactions compared with PBO+LDAC in VIALE-C 1*

Adverse reaction by body system
  VEN+LDAC
(N=142)
PBO+LDAC
(N=68)
Body system Adverse reaction All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%)
Gastrointestinal disorders  Nausea 42 1 31 0
Diarrhea 28 3 16 0
Vomiting 25 <1 13 0
Abdominal pain 15 <1 9 3
Stomatitis 15 1 6 0
Blood and lymphatic system disorders Febrile neutropenia 32 32 29 29
Infections and infestations Pneumonia 29 19 21 21
Vascular disorders  Hemorrhage 27 8 16 1
Hypotension 11 5 4 1
Musculoskeletal and connective tissue disorders Musculoskeletal pain 23 3 18 0
General disorders and administration site conditions Fatigue 22 2 21 0
Nervous system disorders Headache 11 0 6 0

*Patients who received at least one dose of either treatment.
Includes multiple adverse reaction terms.

Hematologic laboratory abnormalities 1

New or worsening Grade 3 or 4 hematologic laboratory abnormalities in VIALE-C with a difference between arms of ≥2% for VEN+LDAC vs PBO+LDAC, respectively:

  • Platelets decreased 95% vs 90%
  • Neutrophils decreased 92% vs 71%
  • Lymphocytes decreased 69% vs 24%
  • Hemoglobin decreased 57% vs 54%

Serious ARs 1

  • Serious adverse reactions were reported in 65% of patients who received VEN+LDAC, with the most frequent (≥10%) being pneumonia (17%), febrile neutropenia (16%), and sepsis (excluding fungal; 12%)

Fatal ARs 1

  • Fatal adverse reactions occurred in 23% of patients who received VENCLEXTA in combination with LDAC, with the most frequent (≥5%) being sepsis (excluding fungal; 7%) and pneumonia (6%)

Adverse reactions leading to discontinuation, dose reductions, and dose interruptions 1

In the VEN+LDAC arm, adverse reactions led to permanent discontinuation of VENCLEXTA in 25% of patients, VENCLEXTA dose reductions in 9%, and VENCLEXTA dose interruptions in 63%.

  • Among patients who achieved bone marrow clearance of leukemia, 32% underwent dose interruptions for ANC <500/microliter
  • The most frequent adverse reaction (>2%) which resulted in permanent discontinuation of VENCLEXTA was pneumonia (6%)
  • Adverse reactions which required a dose reduction in ≥1% of patients were pneumonia (1%) and thrombocytopenia (1%), and the adverse reactions which required a dose interruption in ≥5% of patients included neutropenia (20%), thrombocytopenia (15%), pneumonia (8%), febrile neutropenia (6%), and sepsis (excluding fungal; 6%)

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

AR=adverse reaction; VEN=VENCLEXTA; LDAC=low-dose cytarabine; PBO=placebo; ANC=absolute neutrophil count.

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