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Alecensaro Alectinib Risk of Severe Hypertriglyceridemia and Acute Pancreatitis

Health Canada has identified severe hypertriglyceridemia as a newly characterized adverse reaction associated with Alecensaro (alectinib) in lung cancer patients. Clinical trial data showed hypertriglyceridemia events of any grade in 4.3% of patients and severe or life-threatening events in 1.5%, while five medically confirmed post-marketing cases were reported internationally, including three cases of life-threatening pancreatitis with all patients recovering following treatment. Health Canada is requiring triglyceride monitoring at baseline and periodically, temporary withholding of Alecensaro if triglycerides exceed specified thresholds or pancreatitis occurs, and an update to the Canadian Product Monograph.

Priority review Notice Pharmaceuticals

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