Olezarsen sodium at a glance
Medicine class
Lipid-modifying antisense oligonucleotide
Licensed use
Genetically confirmed familial chylomicronaemia syndrome in adults, alongside diet
Administration
Injection under the skin using a single-use pre-filled pen
Safety monitoring
Subject to additional monitoring for newly identified safety information
What is Olezarsen sodium used for?
Its UK-licensed use is:
Treatment alongside dietary management for adults with genetically confirmed familial chylomicronaemia syndrome, an inherited condition causing extremely high triglyceride levels and a risk of acute pancreatitis.
How does Olezarsen sodium work?
Olezarsen binds APOC3 messenger RNA in liver cells, triggering its breakdown and reducing production of apolipoprotein C-III. This helps the body clear triglyceride-rich particles and lowers blood triglycerides.
Olezarsen sodium preparations and strengths
Injection
Route: Parenteral
Strengths: 80 mg
How to take Olezarsen sodium
Use only after training and follow the instructions supplied with the pen.
Inject under the skin of the abdomen or front of the thigh. A caregiver or healthcare professional may also use the back of the upper arm.
Avoid bruised, tender, red, hard, scarred or damaged skin and the area close to the navel.
Allow the refrigerated pen to reach room temperature naturally; do not use hot water or a microwave.
Do not use solution that is frozen, cloudy or contains particles. A clear, colourless-to-yellow appearance and small air bubbles are acceptable.
Use each pen once and place it directly into an appropriate sharps container.
Olezarsen sodium side effects
Common or expected effects
- Redness, pain, swelling or skin discolouration at the injection site
- Headache
- Joint pain or stiffness
- Vomiting
- Muscle pain
- Chills
Get urgent medical advice
- Severe hypersensitivity, which may cause breathing difficulty, bronchospasm, facial or throat swelling, hives, widespread redness or chills
Olezarsen sodium in pregnancy
There are no clinical pregnancy data. As a precaution, UK product information advises avoiding olezarsen during pregnancy and using effective contraception when pregnancy is possible. Discuss suspected or planned pregnancy promptly with the specialist prescriber.
Olezarsen sodium while breastfeeding
It is unknown whether olezarsen enters human milk or affects a breastfed infant. Substantial infant exposure is considered unlikely because oligonucleotides have poor oral absorption, but risk cannot be excluded. The prescriber should weigh the benefits of breastfeeding against the benefits of treatment.
Olezarsen sodium interactions
Formal interaction studies have not been performed. Its pharmacology suggests a low potential for conventional metabolic interactions.
Statins and fibrates
Olezarsen may be used alongside these lipid-lowering medicines when clinically appropriate.
Medicines metabolised by cytochrome P450 enzymes
A clinically significant CYP-mediated interaction is not expected because olezarsen neither inhibits nor induces these enzymes in vitro.
Highly protein-bound medicines and transporter substrates
Interactions through plasma-protein displacement or common transporters are not expected from in-vitro findings.
Common questions about Olezarsen sodium
Answers are fully visible for fast scanning and source review.
What is olezarsen sodium licensed to treat?
It is licensed in the UK alongside diet for adults with genetically confirmed familial chylomicronaemia syndrome.
Does olezarsen sodium replace a low-fat diet?
No. It is used alongside dietary management.
Can olezarsen sodium be self-injected?
Yes, after appropriate training. The patient or caregiver should follow the product's instructions for use.
What should I do if a pen looks cloudy or frozen?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.