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FCS=familial chylomicronemia syndrome.
Indication
TRYNGOLZA (olezarsen) is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
Important safety information
CONTRAINDICATIONS
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.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
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.
ADVERSE REACTIONS
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. Ionis Pharmaceuticals; 2024. 2. Data on file. Human factors assessment. Ionis Pharmaceuticals; 2024. 3. 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. 4. Gaudet D, Brisson D, Tremblay K, et al. Targeting APOC3 in the familial chylomicronemia syndrome. N Engl J Med. 2014;371(23):2200-2206. 5. 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. 6. 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. 7. 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. 8. 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):e1332-e1342. 9. Gaudet D, Blom D, Bruckert E, et al. Acute pancreatitis is highly prevalent and complications can be fatal in patients with familial chylomicronemia: results from a survey of lipidologist. J Clin Lipidol. 2016;10(3):680-681. National Lipid Association 2016 Scientific Sessions abstract 136. 10. 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. 11. Shemesh E, Zafrir B. Hypertriglyceridemia-related pancreatitis in patients with type 2 diabetes: links and risks. Diabetes Metab Syndr Obes. 2019;12:2041-2052. 12. 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. 13. 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. 14. Data on file. REF-01848. Ionis Pharmaceuticals; 2024. 15. Data on file. REF-01852. Ionis Pharmaceuticals; 2024. 16. Data on file. REF-01850. Ionis Pharmaceuticals; 2024. 17. Data on file. Balance clinical study report. Ionis Pharmaceuticals; 2024.