Safety profile
Adverse reactions were measured in patients receiving RYLAZE1:
- As a component of multiagent chemotherapy
- Consistent with other asparaginase therapies
Common adverse reactions (≥15% incidence)1
Adverse Reaction | RYLAZE 25/25/25 mg/m2 Intramuscular Dosagea (n=33) |
RYLAZE 25/25/50 mg/m2 Intramuscular Dosagea (n=51) |
||
---|---|---|---|---|
All Grades (%) |
Grades 3-4 (%) |
All Grades (%) |
Grades 3-4 (%) |
|
Abnormal liver test*# | 70 | 18 | 75 | 27 |
Musculoskeletal pain* | 45 | 6 | 35 | 4 |
Nausea* | 45 | 9 | 47 | 8 |
Fatigue* | 36 | 18 | 22 | 18 |
Headache | 36 | 0 | 22 | 0 |
Infection*b | 36 | 15 | 27 | 17 |
Febrile neutropenia | 30 | 30 | 27 | 27 |
Pyrexia | 30 | 6 | 20 | 0 |
Hemorrhage* | 24 | 0 | 27 | 6 |
Stomatitis | 24 | 12 | 27 | 4 |
Abdominal pain* | 21 | 0 | 25 | 2 |
Decreased appetite | 21 | 6 | 27 | 6 |
Drug hypersensitivity* | 21 | 6 | 24 | 2 |
Hyperglycemia | 21 | 3 | 12 | 4 |
Diarrhea* | 18 | 6 | 25 | 4 |
Tachycardia* | 18 | 0 | 16 | 2 |
Cough | 15 | 0 | 14 | 0 |
Dehydration | 15 | 9 | 12 | 6 |
Insomnia | 15 | 0 | 4 | 0 |
Periperhal neuropathy* | 15 | 0 | 6 | 0 |
Pancreatitis*# | 12 | 0 | 22 | 10 |
Hypokalemia | 9 | 3 | 22 | 8 |
Adverse Reaction | RYLAZE 25/25/25 mg/m2 Intramuscular Dosagea (n=33) |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
Abnormal liver test*# | 70 | 18 |
Musculoskeletal pain* | 45 | 6 |
Nausea* | 45 | 9 |
Fatigue* | 36 | 18 |
Headache | 36 | 0 |
Infection*b | 36 | 15 |
Febrile neutropenia | 30 | 30 |
Pyrexia | 30 | 6 |
Hemorrhage* | 24 | 0 |
Stomatitis | 24 | 12 |
Abdominal pain* | 21 | 0 |
Decreased appetite | 21 | 6 |
Drug hypersensitivity* | 21 | 6 |
Hyperglycemia | 21 | 3 |
Diarrhea* | 18 | 6 |
Tachycardia* | 18 | 0 |
Cough | 15 | 0 |
Dehydration | 15 | 9 |
Insomnia | 15 | 0 |
Periperhal neuropathy* | 15 | 0 |
Pancreatitis*# | 12 | 0 |
Hypokalemia | 9 | 3 |
Adverse Reaction | RYLAZE 25/25/50 mg/m2 Intramuscular Dosagea (n=51) |
|
---|---|---|
All Grades (%) |
Grades 3-4 (%) |
|
Abnormal liver test*# | 75 | 27 |
Musculoskeletal pain* | 35 | 4 |
Nausea* | 47 | 8 |
Fatigue* | 22 | 18 |
Headache | 22 | 0 |
Infection*b | 27 | 17 |
Febrile neutropenia | 27 | 27 |
Pyrexia | 20 | 0 |
Hemorrhage* | 27 | 6 |
Stomatitis | 27 | 4 |
Abdominal pain* | 25 | 2 |
Decreased appetite | 27 | 6 |
Drug hypersensitivity* | 24 | 2 |
Hyperglycemia | 12 | 4 |
Diarrhea* | 25 | 4 |
Tachycardia* | 16 | 2 |
Cough | 14 | 0 |
Dehydration | 12 | 6 |
Insomnia | 4 | 0 |
Periperhal neuropathy* | 6 | 0 |
Pancreatitis*# | 22 | 10 |
Hypokalemia | 22 | 8 |
*Includes grouped terms.
#Includes adverse event terms and laboratory abnormalities.1
Grading is based on Common Terminology Criteria for Adverse Events version 5.0.1
aRYLAZE was administered as a component of multiagent chemotherapy regimens on a Monday, Wednesday, and Friday schedule.1
bDoes not include the following fatal adverse reactions: infection (n=1).1

See the latest data
Take a look at the sustained asparaginase activity in patients who switched to RYLAZE
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