Safety and tolerability profile
SAFETY PROFILE
For adults with newly diagnosed Ph+ CML-CP
More patients were able to stay on SCEMBLIX by Week 481,2
Dose reductions due to ARs (all-grade)1,2
6% of patients receiving SCEMBLIX (n=200)
19% of patients receiving IS-TKIs (all) (n=201)
14% of patients receiving IS-TKIs (imatinib) (n=99)
24% of patients receiving IS-TKIs (2G TKIs) (n=102)
ARs that required dose reductions in >1% of patients included thrombocytopenia (2.5%) and neutropenia (1.5%).1
Dosage interruptions due to ARs (all-grade)1,2
30% of patients receiving SCEMBLIX (n=200)
40% of patients receiving IS-TKIs (all) (n=201)
34% of patients receiving IS-TKIs (imatinib) (n=99)
45% of patients receiving IS-TKIs (2G TKIs) (n=102)
ARs that required dosage interruption in >5% of patients included thrombocytopenia (13%) and neutropenia (10%).1
SCEMBLIX safety profile for adults with newly diagnosed Ph+ CML-CP
aMusculoskeletal pain includes: musculoskeletal pain, myalgia, pain in extremity, back pain, noncardiac chest pain, bone pain, neck pain, musculoskeletal stiffness, musculoskeletal discomfort, musculoskeletal chest pain, arthritis, and spinal pain.
bRash includes: rash, rash maculo-papular, rash pustular, rash macular, dermatitis exfoliative, drug eruption, dermatitis acneiform, eczema, rash pruritic, and rash vesicular.
cFatigue includes: fatigue and asthenia.
dDiarrhea includes: diarrhea, colitis, and enteritis.
eAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and gastrointestinal pain.
fUpper respiratory tract infection includes: upper respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, and respiratory tract infection.
gDyslipidemia includes: dyslipidemia, hypertriglyceridemia, blood cholesterol increased, hypercholesterolemia, hyperlipidemia, and blood triglycerides increased.
hHeadache includes: headache and migraine.
Serious adverse reactions occurred in 11% of patients who received SCEMBLIX. Serious adverse reactions in ≥1% included pancreatitis (1%) and musculoskeletal pain (1%).1
Laboratory abnormalities
CTCAE version 5.0.
iThe denominator used to calculate the rate for SCEMBLIX and IS-TKIs (all) varied from 198 to 200 and 201, respectively, based on the number of patients with a baseline value and at least one posttreatment value.
jWorst postbaseline laboratory abnormalities based on normal ranges.
EXPANDED SAFETY PROFILE
Safety profile: Expanded by IS-TKI
kMusculoskeletal pain includes: musculoskeletal pain, myalgia, pain in extremity, back pain, non-cardiac chest pain, bone pain, neck pain, musculoskeletal stiffness, musculoskeletal discomfort, musculoskeletal chest pain, arthritis, and spinal pain.1
lRash includes: rash, rash maculo-papular, rash pustular, rash macular, dermatitis exfoliative, drug eruption, dermatitis acneiform, eczema, rash pruritic, and rash vesicular.1
mFatigue includes: fatigue and asthenia.1
nDiarrhea includes: diarrhea, colitis, and enteritis.1
oAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and gastrointestinal pain.1
pUpper respiratory tract infection includes: upper respiratory tract infection, nasopharyngitis, pharyngitis, rhinitis, and respiratory tract infection.1
qDyslipidemia includes: dyslipidemia, hypertriglyceridemia, blood cholesterol increased, hypercholesterolemia, hyperlipidemia, and blood triglycerides increased.1
rHeadache includes: headache and migraine.1
Laboratory abnormalities: Expanded by IS-TKI
CTCAE version 5.0.
sThe denominator used to calculate the rate for SCEMBLIX and IS-TKIs varied from 198 to 200 and 201, respectively, based on the number of patients with a baseline value and at least one post-treatment value.1
tWorst postbaseline laboratory abnormalities based on normal ranges.1
2G, 2nd generation; AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events; IS-TKI, Investigator-selected tyrosine kinase inhibitor; Ph+ CML-CP, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase; TKI, tyrosine kinase inhibitor.