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Scemblix · 4.5 · Medicinal products that may increase asciminib plasma concentrations
Eintrag öffnenScemblix · 4.5 · Medicinal products with known risk of torsades de pointes
Eintrag öffnenScemblix · 4.5 · P-gp substrates with narrow therapeutic index Co-administration of asciminib with a P-gp substrate (digoxin) i
Eintrag öffnenScemblix · 4.5 · Strong CYP3A4 inducers Co-administration of a strong CYP3A4 inducer (rifampicin) decreased asciminib AUCinf by
Eintrag öffnenScemblix · 4.5 · Strong CYP3A4 inhibitors Caution should be exercised during concomitant administration of asciminib at 200 mg
Eintrag öffnenScemblix · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenScemblix · 4.8 Undesirable effects · 1
Eintrag öffnenScemblix · 4.8 · 10 Table 2 Adverse reactions observed with asciminib in clinical studies
Eintrag öffnenScemblix · 4.8 · 11 Description of selected adverse reactions
Eintrag öffnenScemblix · 4.8 · 12 QT prolongation Electrocardiogram QT prolongation occurred in 0.9% of patients receiving asciminib. In the
Eintrag öffnenScemblix · 4.8 · 9 Adverse reactions from clinical studies (Table 2) are listed by MedDRA system organ class. Within each syste
Eintrag öffnenScemblix · 4.8 · Anaemia occurred in 10.4% of patients with the T315I mutation receiving asciminib, with grade 3 and 4 reaction
Eintrag öffnenScemblix · 4.8 · Anaemia occurred in 12.9% of patients receiving asciminib, with grade 3 reactions occurring in 4.1% of patient
Eintrag öffnenScemblix · 4.8 · Frequency System organ class Adverse reaction category Very common Upper respiratory tract infection1 Infectio
Eintrag öffnenScemblix · 4.8 · Hypertension Hypertension occurred in 17.1% of patients receiving asciminib, with grade 3 and 4 reactions repo
Eintrag öffnenScemblix · 4.8 · Hypertension occurred in 14.6% of patients with the T315I mutation receiving asciminib, with grade 3 and 4 rea
Eintrag öffnenScemblix · 4.8 · In the X2101 study, decrease in phosphate levels occurred as a laboratory abnormality in 47.9% (all grades) an
Eintrag öffnenScemblix · 4.8 · Increases in ALT, AST and bilirubin levels occurred as laboratory abnormalities in 50%, 37.5% and 25% (all gra
Eintrag öffnenScemblix · 4.8 · Laboratory abnormalities In the ASCEMBL study, decrease in phosphate levels occurred as a laboratory abnormali
Eintrag öffnenScemblix · 4.8 · Myelosuppression Thrombocytopenia occurred in 28.1% of patients receiving asciminib, with grade 3 and 4 reacti
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