Asciminib

Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP) , previously treated with two or more tyrosine kinase inhibitors, and without a known T315I mutation.

). Hepatic/Biliary/Pancreatic Pancreatic toxicity Pancreatitis occurred in 11 of 556 (2%) patients receiving SCEMBLIX, with grade 3 reactions occurring in 6 (1%) patients. 5%) patients, while it was temporarily withheld in 6 (1%) patients due to pancreatitis.

Asymptomatic elevation of serum lipase and amylase occurred in 107 of 556 (19%) patients receiving SCEMBLIX, with grade 3 and 4 reactions occurring in 41 (7%) and 11 (2%) patients, respectively. SCEMBLIX was permanently discontinued in 11 (2%) patients due to the asymptomatic elevation of serum lipase and amylase (see Monitoring and Laboratory Tests).

If serum lipase and amylase elevation are accompanied by abdominal symptoms, treatment should be temporarily withheld and appropriate diagnostic tests should be considered to exclude pancreatitis (see 4 DOSAGE AND ADMINISTRATION). Based on the severity of serum lipase and amylase elevation, the SCEMBLIX dose should be reduced, temporarily withheld or permanently discontinued as described in Table 2 (see 4 DOSAGE AND ADMINISTRATION).

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