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Safety profile in the Phase 3 trial1

Reported adverse reactions with VYXEOS were generally consistent with the known safety profile of 7+3a

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

Adverse reaction All gradesb Grades 3 to 5b
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 gradesb
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 5b
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% of patients in the control arm.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

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

IMPORTANT SAFETY INFORMATION

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

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.