Serious adverse reactions occurred in 23% of patients who received SCEMBLIX. Serious adverse reactions in >1% included abdominal pain (4.2%), vomiting (4.2%), pneumonia (4.2%), musculoskeletal pain (2.1%), headache (2.1%), hemorrhage (2.1%), constipation (2.1%), arrhythmia (2.1%), and pleural effusion (2.1%).1
aURTI includes: nasopharyngitis, upper respiratory tract infection, rhinitis, pharyngitis, respiratory tract infection, and pharyngotonsillitis.
bMusculoskeletal pain includes: pain in extremity, back pain, myalgia, noncardiac chest pain, neck pain, bone pain, spinal pain, arthritis, and musculoskeletal pain.
cRash includes: rash, rash maculopapular, dermatitis acneiform, rash pustular, eczema, dermatitis, skin exfoliation, dermatitis exfoliative generalized, rash morbilliform, drug eruption, erythema multiform, and rash erythematous.
dDiarrhea includes: diarrhea and colitis.
eAbdominal pain includes: abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and epigastric discomfort.
fFatigue includes: fatigue and asthenia.
gHypertension includes: hypertension and hypertensive crisis.
hThe denominator used to calculate the rate for SCEMBLIX and bosutinib varied from 145 to 156 and 71 to 76, respectively, based on the number of patients with a baseline value and at least one post-treatment value.
iMusculoskeletal pain includes: pain in extremity, back pain, myalgia, musculoskeletal pain, noncardiac chest pain, bone pain, arthritis, and musculoskeletal chest pain.
jRash includes: rash, rash maculopapular, dermatitis acneiform, eczema, rash papular, skin exfoliation, and dyshidrotic eczema.
kHeadache includes: headache and migraine.
lAbdominal pain includes: abdominal pain and hepatic pain.
mHemorrhage includes: epistaxis, ear hemorrhage, mouth hemorrhage, postprocedural hemorrhage, skin hemorrhage, and vaginal hemorrhage.
nCough includes: cough and productive cough.
oURTI includes: upper respiratory tract infection, nasopharyngitis, rhinitis, and pharyngitis.
pThe denominator used to calculate the rate was 48 based on the number of patients with a baseline value and at least one post-treatment value.
References: 1. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Data on file. Week 48 Analysis Safety Set Tables. Novartis Pharmaceuticals Corp; 2021. 3. Data on file. 30 Day Safety Update. Novartis Pharmaceuticals Corp; 2021.
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