RX Review: Monitoring and Safety Considerations in FCS

As the cardiology community embraces the new, targeted-therapy era of management for familial chylomicronemia syndrome (FCS), an integral aspect of conversations becomes safety and monitoring considerations.

In part 6 of this 7-part video series, Le and Ballantyne shift attention to the safety considerations that accompany modern FCS therapies. Ballantyne reviews common adverse events encountered with injectable triglyceride-lowering agents, including olezarsen and plozasiran. These include injection site reactions, mild flu-like symptoms, transient hyperglycemia, and rare systemic complications. He notes safety profiles observed during clinical trials have been generally favorable, especially when compared with older triglyceride-lowering therapies. Regular monitoring, including lipid panels and periodic blood glucose assessments, provides an essential foundation for tracking response and detecting emerging issues early.

The conversation addresses the importance of patient counseling in promoting safe and sustained therapy use. Ballantyne emphasizes that clinicians should prepare patients for expected injection site reactions and reassure them that most reactions are mild and manageable. Structured follow-up visits allow clinicians to assess tolerability, address concerns, and adjust therapy as needed. Le and Ballantyne stress open communication improves adherence and helps ensure safety events do not lead to unnecessary discontinuation of therapy.

This segment concludes by outlining the central role of interdisciplinary collaboration in safety monitoring. Ballantyne reiterates safety monitoring is not merely a formality but a core component of modern FCS management ensuring patients benefit fully from these advanced therapies.

Relevant disclosures for Ballantyne include Arrowhead Pharmaceuticals, Inois, Merck, Novartis, Novo Nordisk, New Amsterdam, Esperion, AstraZeneca, Eli Lilly, and others. Relevant disclosures for Le include Amarin, Bayer, Esperion, Idorsia, Janssen, Novo Nordisk, Novartis, Lexicon Pharmaceuticals, and Pfizer.

References:

Arrowhead Pharmaceuticals. Arrowhead Pharmaceuticals Announces FDA Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) - Arrowhead Pharmaceuticals, Inc. Arrowhead Pharmaceuticals, Inc. Published November 19, 2025. Accessed November 25, 2025. https://arrowheadpharma.com/news-press/arrowhead-pharmaceuticals-announces-fda-approval-of-redemplo-plozasiran-to-reduce-triglycerides-in-adults-with-familial-chylomicronemia-syndrome-fcs/.

Virani SS, Morris PB, Agarwala A, et al. 2021 ACC Expert Consensus Decision Pathway on the Management of ASCVD Risk Reduction in Patients With Persistent Hypertriglyceridemia: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021;78(9):960-993. doi:10.1016/j.jacc.2021.06.011

US Food and Drug Administration. FDA approves Tryngolza (olezarsen). U.S. Food and Drug Administration. Published December 19, 2024. Accessed November 25, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-reduce-triglycerides-adult-patients-familial-chylomicronemia-syndrome.