TRYNGOLZA (olezarsen) is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred.
Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur.
Most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count, and arthralgia.
Please see full Prescribing Information for TRYNGOLZA.
References: 1. TRYNGOLZA. Prescribing information. lonis Pharmaceuticals. 2. Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al; Balance Investigators. Olezarsen, acute pancreatitis, and familial chylomicronemia syndrome. N Engl J Med. 2024,390(19):1781-1792. 3. Data on file. Human factors assessment. lonis Pharmaceuticals; 2024. 4. Ginsberg HN, Packard CJ, Chapman MJ, et al. Triglyceride-rich lipoproteins and their remnants: metabolic insights, role in atherosclerotic cardiovascular disease, and emerging therapeutic strategies-a consensus statement from the European Atherosclerosis Society. Eur Heart J. 2021;42(47):4791-4806. 5. Hegele RA, Ahmad Z, Ashraf A, et al. Development and validation of clinical criteria to identify familial chylomicronemia syndrome (FCS) in North America. J Clin Lipidol. 2025;19(1):83-94. 6. 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. 7. Javed F, Hegele RA, Garg A, et al. Familial chylomicronemia syndrome: an expert clinical review from the National Lipid Association. J Clin Lipidol. 2025;19(3):382-403. 8. Sanchez RJ, Ge W, Wei W, Ponda MP, Rosenson RS. The association of triglyceride levels with the incidence of initial and recurrent acute pancreatitis. Lipids Health Dis. 2021;20(1):72. 9. Skulas-Ray AC, Wilson PWF, Harris WS, et al. Omega-3 fatty acids for the management of hypertriglyceridemia: a science advisory from the American Heart Association. Circulation. 2019;140(12):673-e691. 10. Kirkpatrick CF, Sikand G, Petersen KS, et al. Nutrition interventions for adults with dyslipidemia: a clinical perspective from the National Lipid Association. J Clin Lipidol. 2023;17(4):428-451. 11. Newman CB, Blaha MJ, Boord JB, et al. Lipid management in patients with endocrine disorders: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2020;105(12):3613-3682. 12. Hegele RA, Ahmad Z, Ashraf A, et al. Development and validation of clinical criteria to identify familial chylomicronemia syndrome (FCS) in North America. J Clin Lipidol. 2025;19(1)(online-only supplementary material):83-94. 13. D'Erasmo L, Di Costanzo A, Cassandra F, et al. Spectrum of mutations and long-term clinical outcomes in genetic chylomicronemia syndromes. Arterioscler Thromb Vasc Biol. 2019;39(12):2531-2541. 14. Saadatagah S, Larouche M, Naderian M, et al. Recognition and management of persistent chylomicronemia: a joint expert clinical consensus by the National Lipid Association and the American Society for Preventive Cardiology. J Clin Lipidol. 2025;19(4):723-736. 15. Paquette M, Bernard S. The evolving story of multifactorial chylomicronemia syndrome. Front Cardiovasc Med. 2022;9:886266. 16. Baass A, Paquette M, Bernard S, Hegele RA. Familial chylomicronemia syndrome: an under-recognized cause of severe hypertriglyceridaemia. J Intern Med. 2020;287(4):340-348. 17. Davidson M, Stevenson M, Hsieh A, et al. The burden of familial chylomicronemia syndrome: results from the global IN-FOCUS study. J Clin Lipidol. 2018;12(4):898-907.e2. 18. Pallazola VA, Sajja A, Derenbecker R, et al. Prevalence of familial chylomicronemia syndrome in a quaternary care center. Eur J Prev Cardiol. 2020;27(19):2276-2278. 19. Moulin P, Dufour R, Averna M, et al. Identification and diagnosis of patients with familial chylomicronaemia syndrome (FCS): expert panel recommendations and proposal of an "FCS score". Atherosclerosis. 2018;275:265-272. 20. Brinton EA, Eckel RH, Gaudet D, et al. Familial chylomicronemia syndrome and treatments to target hepatic APOC3 mRNA. Atherosclerosis. 2025;403:119114. 21. Belhassen M, Van Ganse E, Nolin M, et al. 10-year comparative follow-up of familial versus multifactorial chylomicronemia syndromes. J Clin Endocrinol Metab. 2021;106(3):1332-e1342. 22. Nawaz H, Koutroumpakis E, Easler J, et al. Elevated serum triglycerides are independently associated with persistent organ failure in acute pancreatitis. Am J Gastroenterol. 2015;110(10):1497-1503. 23. Shemesh E, Zafrir B. Hypertriglyceridemia-related pancreatitis in patients with type 2 diabetes: links and risks. Diabetes Metab Syndr Obes. 2019;12:2041-2052. 24. Chyzhyk V, Brown AS. Familial chylomicronemia syndrome: a rare but devastating autosomal recessive disorder characterized by refractory hypertriglyceridemia and recurrent pancreatitis. Trends Cardiovasc Med. 2020;30(2):80–85. 25. Gaudet D, Brisson D, Tremblay K, et al. Targeting APOC3 in the familial chylomicronemia syndrome. N Engl J Med. 2014;371(23):2200-2206. 26. Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al; Balance Investigators. Olezarsen, acute pancreatitis, and familial chylomicronemia syndrome. N Engl J Med. 2024;390(19)(supplementary appendix):1781-1792. 27. Data on file. REF-01848. Ionis Pharmaceuticals; 2024. 28. Data on file. REF-01852. Ionis Pharmaceuticals; 2024. 29. Data on file. REF-01850. Ionis Pharmaceuticals; 2024.