DISCLAIMER: This publication is intended for healthcare professionals. The information provided aims to update on medication safety issues and should not substitute clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss arising from the use of or reliance on this publication.
Overview
In Malaysia, Alecensa® (alectinib) capsules are approved as:
- Adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
- Monotherapy for adult patients with ALK-positive advanced NSCLC, either as first-line treatment or previously treated with crizotinib.
Background of the Safety Issue
Severe hypertriglyceridaemia is considered a medical emergency, as it may lead to acute pancreatitis. Hypertriglyceridaemia-induced pancreatitis cases have been reported in the postmarketing period for Alecensa®, including one case with a positive rechallenge following Alecensa® resumption. Despite the reported cases, the overall benefit-risk profile of Alecensa® remains favourable.
Regulatory Action
On 7 April 2026, NPRA approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to inform healthcare professionals of this safety issue. For further information, please contact your local salesperson for a copy of the DHPC. The product label for Alecensa® will be updated to reflect this new identified risk.
Advice for Health Care Professionals
- Be aware of the risk of severe hypertriglyceridaemia in patients treated with Alecensa®, which may potentially lead to acute pancreatitis.
- Measure patients’ baseline blood triglycerides before starting Alecensa® and monitor periodically during treatment.
- Monitor patients for symptoms indicative of acute pancreatitis, particularly those at increased risk. Treatable risk factors for pancreatitis should be evaluated and addressed before starting treatment with Alecensa®.
- If severe or life-threatening elevations of blood triglycerides occur, temporarily withhold Alecensa® until levels recover to at least moderate hypertriglyceridaemia (blood triglycerides >300 to 500 mg/dL or >3.42 to 5.7 mmol/L).
- Report all suspected adverse events related to the use of alectinib to the NPRA.
References
- Direct Healthcare Professional Communication (DHPC). Alecensa@ (Alectinib), Guidance for Management of Severe Hypertriglyceridaemia. Roche (Malaysia) Sdn. Bhd.; 2026 Apr 07.