Olezarsen: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 17, 2026🚩 Report this page

Olezarsen

Active ingredient

Sold as Tryngolza

GB MHRAEU EMACA Health Canada

Drug class: -
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 3

Overview

Olezarsen is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	April 17, 2026
EU European Union	EMA	1	December 3, 2025
CA Canada	Health Canada	1	March 9, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised April 17, 2026[1]

Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 3, 2025[2]

Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).

How to take

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

TRYNGOLZATHERATECHNOLOGIES INC

Sources & citations

[1]MHRA (UK) · PL309410031 · revised April 17, 2026
[2]European Medicines Agency · EMEA/H/C/006477 · revised December 3, 2025
[3]Health Canada (DPD) · 02563886 · revised March 9, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]

Summary of the safety profile In patients with FCS, the most commonly reported adverse reactions during treatment with olezarsen were injection site erythema (17%), headache (16%), arthralgia (15%), and vomiting (10%). Tabulated list of adverse reactions The safety data described below reflects exposure to olezarsen in 89 patients with FCS in clinical trials who received at least one dose of olezarsen.
Of these, 77 patients received at least 6 months of treatment and 65 patients received at least 12 months of treatment. The mean duration of treatment for these patients was 521 days (range: 28 to 1 080 days). Adverse reactions are listed according to MedDRA system organ class.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Very common Common Immune system disorders Hypersensitivity Nervous system disorders Headache Gastrointestinal disorders Vomiting Musculoskeletal and connective tissue disorders Arthralgia Myalgia General disorders and administration site conditions Injection site erythema Injection site discolouration Chills Injection site pain Injection site swelling Description of selected adverse reactions Hypersensitivity Hypersensitivity has been observed with olezarsen.
Severe hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been observed in 2 patients in clinical trials. In both patients the event was acute, required treatment, and resulted in treatment discontinuation.
Injection site reactions Injection site reactions occurred in olezarsen-treated patients with FCS. These local reactions were mostly mild and consisted of injection site erythema (17%), discolouration (9%), pain (6%), and swelling (5%).
These events are either self- limiting or can usually be managed using symptomatic treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]

8). If a serious hypersensitivity reaction occurs, Tryngolza must be discontinued immediately and appropriate therapy initiated. General Limited safety data exist for olezarsen use in FCS patients at the time of marketing authorisation.
While no serious risks of thrombocytopenia, hepatotoxicity, or renal toxicity were identified during clinical development, these adverse reactions have been observed with some antisense oligonucleotides and cannot be completely excluded.
Use in patients with low platelet counts Some patients with FCS are susceptible to platelet count variability over time as part of the natural history and progression of the disease. There are limited data available on the use of olezarsen in FCS patients with platelet count < 100 000/mm3.
Excipient with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised December 3, 2025[2]

Summary of the safety profile In patients with FCS, the most commonly reported adverse reactions during treatment with olezarsen were injection site erythema (17%), headache (16%), arthralgia (15%), and vomiting (10%). Tabulated list of adverse reactions The safety data described below reflects exposure to olezarsen in 89 patients with FCS in clinical trials who received at least one dose of olezarsen.
Of these, 77 patients received at least 6 months of treatment and 65 patients received at least 12 months of treatment. The mean duration of treatment for these patients was 521 days (range: 28 to 1 080 days). Adverse reactions are listed according to MedDRA system organ class.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 1:
Adverse reactions System organ class Very common Common Immune system disorders Hypersensitivity Nervous system disorders Headache Gastrointestinal disorders Vomiting Musculoskeletal and connective tissue disorders Arthralgia Myalgia General disorders and administration site conditions Injection site erythema Injection site discolouration Chills Injection site pain Injection site swelling Description of selected adverse reactions Hypersensitivity Hypersensitivity has been observed with olezarsen.
Severe hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been observed in 2 patients in clinical trials. In both patients the event was acute, required treatment, and resulted in treatment discontinuation.
Injection site reactions Injection site reactions occurred in olezarsen-treated patients with FCS. These local reactions were mostly mild and consisted of injection site erythema (17%), discolouration (9%), pain (6%), and swelling (5%).
These events are either self-limiting or can usually be managed using symptomatic treatment. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised December 3, 2025[2]

8). If a serious hypersensitivity reaction occurs, Tryngolza must be discontinued immediately and appropriate therapy initiated. General Limited safety data exist for olezarsen use in FCS patients at the time of marketing authorisation.
While no serious risks of thrombocytopenia, hepatotoxicity, or renal toxicity were identified during clinical development, these adverse reactions have been observed with some antisense oligonucleotides and cannot be completely excluded.
Use in patients with low platelet counts Some patients with FCS are susceptible to platelet count variability over time as part of the natural history and progression of the disease. There are limited data available on the use of olezarsen in FCS patients with platelet count < 100 000/mm3.
4 Excipient with known effect Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.