🇨🇦 ALECENSARO (alectinib) and the Risk of Severe Hypertriglyceridemia

Hazard/Reason: Hypertriglyceridemia, including severe and life-threatening events, has been identified as an adverse reaction associated with ALECENSARO. Severe hypertriglyceridemia is considered a medical emergency, as it may lead to acute pancreatitis.   Audience Healthcare professionals involved in the treatment of lung cancer, including medical oncologists, thoracic surgeons, surgical oncologists (Quebec), respirologists, oncology nurses, and oncology pharmacists.   Key messages Hypertriglyceridemia, including severe and life-threatening events, has been identified as an adverse reaction associated with ALECENSARO (alectinib). Severe hypertriglyceridemia is considered a medical emergency, as it may lead to acute pancreatitis. Healthcare professionals are advised that: Patients should be counselled on the risks and benefits of ALECENSARO, including the risk of hypertriglyceridemia. Blood triglyceride levels should be measured at baseline before initiating ALECENSARO and periodically during treatment. Patients should be monitored for signs and symptoms of acute pancreatitis, especially those at increased risk. If an acute episode of pancreatitis occurs, ALECENSARO should be temporarily withheld until full recovery before resuming treatment. ALECENSARO should also be temporarily withheld in patients who develop severe or life-threatening hypertriglyceridemia until triglyceride levels recover to moderate levels (see the Information to healthcare professionals section). The Canadian Product Monograph for ALECENSARO will be updated to include this safety information.   Background information ALECENSARO is indicated: for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). as monotherapy for the treatment of patients with ALK-positive, locally advanced (not amenable to curative therapy) or metastatic NSCLC who have progressed on or are intolerant to crizotinib. for adjuvant treatment following tumour resection for patients with stage IB (tumours ≥ 4 cm) to IIIA* ALK-positive NSCLC.        *According to the American Joint Committee on Cancer [7th edition]. Cumulative data from clinical studies and post-marketing sources identified hypertriglyceridemia as a risk associated with ALECENSARO. Hypertriglyceridemia adverse events of any grade were reported in 4.3% of patients from pivotal clinical trials, and severe or life-threatening hypertriglyceridemia adverse events were reported in 1.5% of patients from these trials. The onset of severe or life-threatening hypertriglyceridemia adverse events ranged from 106 to 1001 days. Triglycerides were not consistently monitored in clinical trials. In 3 clinical trials in which triglycerides were measured, laboratory data showed increases from baseline, where the majority of shifts from baseline were from normal to grade 1 (150 mg/dL to 300 mg/dL; 1.71 mmol/L to 3.42 mmol/L); however, grade ≥3 laboratory elevations were also reported in these trials. Overall, observed cases of hypertriglyceridemia were mostly mild to moderate in severity. In the post-marketing setting, five medically confirmed severe to life-threatening cases of hypertriglyceridemia were reported internationally in patients treated with ALECENSARO. Three of these cases resulted in life-threatening pancreatitis, with all patients ultimately recovering following treatment. One of these cases demonstrated a positive rechallenge for life-threatening hypertriglyceridemia upon ALECENSARO resumption. The onset of these serious cases ranged from 6 weeks to 1 year after the start of ALECENSARO treatment.   Information for consumers ALECENSARO (alectinib) is a prescription medicine used to treat non-small cell lung cancer in adults.  ALECENSARO can cause high levels of triglycerides (a type of fat) in the blo

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