olezarsen
Tryngolza · ATC code C10AX
- Key facts
- Active substance
- olezarsen
- ATC code
- C10AX
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tryngolza 80 mg solution for injection in pre-filled pen
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB (publ)
- Information as of
- 2026-10-29
Key facts
Olezarsen (Tryngolza) is an antisense oligonucleotide injected subcutaneously once a month to lower triglycerides in familial chylomicronaemia syndrome.
What it is used for
- Adjunct to diet in adults with genetically confirmed familial chylomicronemia syndrome (FCS).
Dosing
- 80 mg once monthly by subcutaneous injection; not intramuscularly.
- A missed dose should be given as soon as possible; monthly intervals restart from the most recent dose.
- Inject into the abdomen or front of the thigh, or the back of the upper arm if given by a carer; avoid damaged skin and the area around the navel.
- No dose adjustment at ≥ 65 years, in mild or moderate renal impairment, or in mild hepatic impairment; in severe renal or moderate to severe hepatic impairment use only if the benefit outweighs the risk.
- Discontinuation may be considered if there is no response after 6 months.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Hypersensitivity reactions (e.g. diffuse erythema, chills); stop immediately if a serious reaction occurs.
- Limited safety data; thrombocytopenia, hepatotoxicity and renal toxicity, seen with some antisense oligonucleotides, cannot be completely excluded.
- Limited data in patients with low platelet counts.
Side effects
- Most common: injection site erythema (17%), headache (16%), arthralgia (15%) and vomiting (10%).
- Others: hypersensitivity, myalgia, chills, injection site discolouration, pain and swelling.
Interactions
- No interaction studies; interactions via transporters, plasma protein binding or CYP enzymes are not expected.
- Can be used with other lipid-lowering medicines such as statins and fibrates.
Pregnancy and breastfeeding
- As a precaution, use during pregnancy is preferably avoided; women of child-bearing potential should use effective contraception.
- There is no information on excretion in human milk.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- TryngolzaSwedish Orphan Biovitrum AB (publ) · EMEA/H/C/006477
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Tryngolza
- Liechtenstein
- Tryngolza
- Norway
- Tryngolza
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Tryngolza – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tryngolza-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.