Reported adverse reactions were generally consistent with the known safety profile of cytarabine and daunorubicin therapy

Common adverse reactions (≥10% incidence in the VYXEOS arm) during the induction phase

  • Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and 0.7% of patients in the control arm1
Adverse reaction All gradesa
VYXEOS
(n=153) n (%)
7+3b
(n=151) n (%)
Hemorrhage 107 (70) 74 (49)
Febrile neutropenia 104 (68) 103 (68)
Rash 82 (54) 55 (36)
Edema 78 (51) 90 (60)
Nausea 72 (47) 79 (52)
Diarrhea/Colitis 69 (45) 100 (66)
Mucositis 67 (44) 69 (46)
Constipation 61 (40) 57 (38)
Musculoskeletal pain 58 (38) 52 (34)
Abdominal pain 51 (33) 45 (30)
Cough 51 (33) 34 (23)
Headache 51 (33) 36 (24)
Dyspnea 49 (32) 51 (34)
Fatigue 49 (32) 58 (38)
Arrhythmia 46 (30) 41 (27)
Decreased appetite 44 (29) 57 (38)
Pneumonia (excluding fungal) 39 (26) 35 (23)
Sleep disorders 38 (25) 42 (28)
Bacteremia (excluding sepsis) 37 (24) 37 (25)
Vomiting 37 (24) 33 (22)
Chills 35 (23) 38 (25)
Hypotension 30 (20) 32 (21)
Non-conduction cardiotoxicity 31 (20) 27 (18)
Dizziness 27 (18) 26 (17)
Fungal infection 27 (18) 19 (13)
Hypertension 28 (18) 22 (15)
Hypoxia 28 (18) 31 (21)
Upper respiratory infections (excluding fungal) 28 (18) 19 (13)
Chest pain 26 (17) 22 (15)
Pyrexia 26 (17) 23 (15)
Catheter/device/injection site reaction 24 (16) 15 (10)
Delirium 24 (16) 33 (22)
Pleural effusion 24 (16) 25 (17)
Anxiety 21 (14) 16 (11)
Pruritus 23 (15) 14 (9)
Sepsis (excluding fungal) 17 (11) 20 (13)
Hemorrhoids 16 (11) 12 (8)
Petechiae 17 (11) 17 (11)
Renal insufficiency 17 (11) 17 (11)
Transfusion reactions 17 (11) 16 (11)
Visual impairment (except bleeding) 16 (11) 8 (5)
Adverse reaction Grades 3 to 5a
VYXEOS
(n=153) n (%)
7+3b
(n=151) n (%)
Hemorrhage 15 (10) 9 (6)
Febrile neutropenia 101 (66) 102 (68)
Rash 8 (5) 2 (1)
Edema 2 (2) 5 (3)
Nausea 1 (1) 1 (1)
Diarrhea/Colitis 4 (3) 10 (7)
Mucositis 2 (1) 7 (5)
Constipation 0 0
Musculoskeletal pain 5 (3) 4 (3)
Abdominal pain 3 (2) 3 (2)
Cough 0 1 (1)
Headache 2 (1) 1 (1)
Dyspnea 17 (11) 15 (10)
Fatigue 8 (5) 8 (5)
Arrhythmia 10 (7) 7 (5)
Decreased appetite 2 (1) 5 (3)
Pneumonia (excluding fungal) 30 (20) 26 (17)
Sleep disorders 2 (1) 1 (1)
Bacteremia (excluding sepsis) 35 (23) 31 (21)
Vomiting 0 0
Chills 0 0
Hypotension 7 (5) 1 (1)
Non-conduction cardiotoxicity 13 (9) 15 (10)
Dizziness 1 (1) 0
Fungal infection 11 (7) 9 (6)
Hypertension 15 (10) 8 (5)
Hypoxia 19 (12) 23 (15)
Upper respiratory infections (excluding fungal) 4 (3) 1 (1)
Chest pain 5 (3) 0
Pyrexia 1 (1) 2 (1)
Catheter/device/injection site reaction 0 0
Delirium 4 (3) 9 (6)
Pleural effusion 3 (2) 2 (1)
Anxiety 0 0
Pruritus 0 0
Sepsis (excluding fungal) N/A N/A
Hemorrhoids 0 0
Petechiae 0 0
Renal insufficiency 7 (5) 7 (5)
Transfusion reactions 3 (2) 1 (1)
Visual impairment (except bleeding) 0 0
  1. Adverse reactions were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
  2. Cytarabine and daunorubicin.

Lower 30- and 60-day mortality rates vs 7+31,a

30- and 60-day overall all-cause mortality1

Vyxeos mortality in AML
  • 9 patients each in the VYXEOS arm (6%) and control arm (6%) had a fatal adverse reaction on treatment or within 30 days of therapy that was not in the setting of progressive disease1
  • Fatal adverse reactions in the VYXEOS arm included infection, CNS hemorrhage, and respiratory failure1
  1. Cytarabine and daunorubicin.

Time to recovery of absolute neutrophil count and platelets may be prolonged with VYXEOS and require additional monitoring1

Prolonged cytopenias for patients in Phase 3 trial1
Induction 1
VYXEOS
(n=58) n (%)
7+3b
(n=34) n (%)
Prolonged thrombocytopeniaa 16 (28) 4 (12)
Prolonged neutropeniaa 10 (17) 1 (3)
Prolonged cytopenias for patients in Phase 3 trial1
Consolidation 1c
VYXEOS
(n=48) n (%)
5+2b
(n=32) n (%)
Prolonged thrombocytopeniaa 12 (25) 5 (16)
Prolonged neutropeniaa 5 (10) 1 (3)
  1. Platelets <50 Gi/L or neutrophils <0.5 Gi/L lasting past cycle Day 42 in the absence of active leukemia.
  2. Cytarabine and daunorubicin.
  3. Patients receiving at least 1 consolidation.