Health Canada22 Apr 2026
ALECENSARO (alectinib) and the Risk of Severe Hypertriglyceridemia
Health Canada published a recall notice for ALECENSARO (alectinib) and the Risk of Severe Hypertriglyceridemia on 22 Apr 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 22 Apr 2026
- Recall type
- Health professional risk communication
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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 pr Affected products: ALECENSARO, alectinib capsules, 150 mg Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.