Safety and tolerability profile
SAFETY PROFILE
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
Select 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.
DISCONTINUATION RATES
Permanent discontinuation due to adverse reactions at Week 48
Permanent discontinuation of SCEMBLIX due to an AR that occurred in ≥1% of patients included pancreatic enzymes increased (1.5%) and thrombocytopenia (1%)1
Dosage interruptions of SCEMBLIX due to an AR occurred in 30% of patients. ARs that required dosage interruption in >5% of patients included thrombocytopenia (13%) and neutropenia (10%)1
Dose reductions of SCEMBLIX due to an AR occurred in 6% of patients. ARs that required dose reductions in >1% of patients included thrombocytopenia (2.5%) and neutropenia (1.5%)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.
By Week 48, 90% of patients who received SCEMBLIX were still on treatment vs 81% of patients who received IS-TKIs (all).1