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VYXEOS safety profile in the Phase 3 trial1

Common adverse reactions (≥20% incidence in the VYXEOS arm) during the induction phase1

Adverse reaction All gradesa Grades 3 to 5a
VYXEOS
(N=153)
n (%)
7+3
(N=151)
n (%)
VYXEOS
(N=153)
n (%)
7+3
(N=151)
n (%)
Hemorrhage 107 (70) 74 (49) 15 (10) 9 (6)
Febrile neutropenia 104 (68) 103 (68) 101 (66) 102 (68)
Rash 82 (54) 55 (36) 8 (5) 2 (1)
Edema 78 (51) 90 (60) 2 (2) 5 (3)
Nausea 72 (47) 79 (52) 1 (1) 1 (1)
Diarrhea/colitis 69 (45) 100 (66) 4 (3) 10 (7)
Mucositis 67 (44) 69 (46) 2 (1) 7 (5)
Constipation 61 (40) 57 (38) 0 0
Musculoskeletal pain 58 (38) 52 (34) 5 (3) 4 (3)
Abdominal pain 51 (33) 45 (30) 3 (2) 3 (2)
Cough 51 (33) 34 (23) 0 1 (1)
Headache 51 (33) 36 (24) 2 (1) 1 (1)
Dyspnea 49 (32) 51 (34) 17 (11) 15 (10)
Fatigue 49 (32) 58 (38) 8 (5) 8 (5)
Arrhythmia 46 (30) 41 (27) 10 (7) 7 (5)
Decreased appetite 44 (29) 57 (38) 2 (1) 5 (3)
Pneumonia (excluding fungal) 39 (26) 35 (23) 30 (20) 26 (17)
Sleep disorders 38 (25) 42 (28) 2 (1) 1 (1)
Bacteremia (excluding sepsis) 37 (24) 37 (25) 35 (23) 31 (21)
Vomiting 37 (24) 33 (22) 0 0
Chills 35 (23) 38 (25) 0 0
Hypotension 30 (20) 32 (21) 7 (5) 1 (1)
Non-conduction cardiotoxicity 31 (20) 27 (18) 13 (9) 15 (10)
Adverse reaction All gradesa
VYXEOS
(N=153)
n (%)
7+3
(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)
Adverse reaction Grades 3 to 5a
VYXEOS
(N=153)
n (%)
7+3
(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)

Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and 0.7% in the control arm (7+3)1

Other adverse reactions that occurred in ≥10% of patients in the VYXEOS arm included: dizziness, fungal infection, hypertension, hypoxia, upper respiratory infections (excluding fungal), chest pain, pyrexia, catheter/device/injection site reaction, delirium, pleural effusion, anxiety, pruritus, sepsis (excluding fungal), hemorrhoids, petechiae, renal insufficiency, transfusion reactions, and visual impairment (except bleeding)1

The safety population included all patients in the VYXEOS cohort and 151 patients from the 7+3 cohort (5 patients withdrew consent before the receipt of treatment)2

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

  • Incidences of Grade 3 thrombocytopeniab were prolonged in the absence of active leukemia in 28% (16/58) of patients in the VYXEOS arm and 12% (4/34) in the 7+3 arm during Induction 1 and in 25% (12/48) in the VYXEOS arm and 16% (5/32) in the 5+2 arm during Consolidation 1c
  • Incidences of Grade 4 neutropeniab were prolonged in the absence of active leukemia in 17% (10/58) of patients in the VYXEOS arm and 3% (1/34) in the 7+3 arm during Induction 1 and in 10% (5/48) in the VYXEOS arm and 3% (1/32) in the 5+2 arm during Consolidation 1c

INDICATION

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

IMPORTANT SAFETY INFORMATION

INDICATION

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Important Safety Information

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.