WARNINGS
Do not use TRYNGOLZA if:
you have had a serious allergic reaction to olezarsen or any of the ingredients in TRYNGOLZA. See the end of this Patient Information for a complete list of ingredients.
USES
What is TRYNGOLZA?
TRYNGOLZA is a prescription medicine used along with diet to reduce triglycerides (fat in the blood) in the treatment of adults with a condition that keeps the body from breaking down fats called familial chylomicronemia syndrome (FCS).
It is not known if TRYNGOLZA is safe and effective in children.
HOW TO USE
How should I use TRYNGOLZA?
Read the detailed Instructions for Use that comes with your TRYNGOLZA single-dose autoinjector.
Your healthcare provider will show you and/or your caregiver how to inject TRYNGOLZA the first time.
TRYNGOLZA is injected under your skin (subcutaneous use) in your stomach area (abdomen) or the front of your upper legs (thighs). Only a healthcare provider or caregiver may give you an injection in the back of your upper arm.
TRYNGOLZA should be injected 1 time each month.
If you miss a dose, take the missed dose as soon as possible. Then inject TRYNGOLZA 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your dosing schedule, ask your healthcare provider.
Stay on your low-fat diet (less than 20 grams of fat each day) while using TRYNGOLZA.
What are the possible side effects of TRYNGOLZA?
Allergic reactions: TRYNGOLZA can cause side effects including allergic reactions that may be serious. Allergic reactions can include redness of the skin, red itchy bumps (hives), swelling of the face, chills or trouble breathing. Stop taking TRYNGOLZA and call your healthcare provider or get emergency help right away if you have any of these symptoms.
The most common side effects of TRYNGOLZA include:
injection site reactions (such as redness or pain at the injection site)
decreased platelet count (blood cells that help to clot blood)
joint pain or stiffness
These are not all the possible side effects of TRYNGOLZA. Tell your healthcare provider if you have
any side effect that bothers you or that does not go away while taking TRYNGOLZA. Call your doctor
for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
General information about the safe and effective use of TRYNGOLZA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use TRYNGOLZA for a condition for which it was not prescribed. Do not give TRYNGOLZA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TRYNGOLZA that is written for health professionals.
What are the ingredients in TRYNGOLZA?
Active ingredient: olezarsen sodium.
Inactive ingredients: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate to maintain pH and provide tonicity and water for injection. The solution may include hydrochloric acid and/or sodium hydroxide for pH adjustment.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
If you miss a dose, take the missed dose as soon as possible. Then inject TRYNGOLZA 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your dosing schedule, ask your healthcare provider.
STORAGE
How should I store TRYNGOLZA?
Store TRYNGOLZA autoinjector in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C) in the original carton.
TRYNGOLZA can also be stored at room temperature between 59-degrees F to 86-degrees F (15-degrees C to 30-degrees C) in the original carton for up to 6 weeks.
Do not let TRYNGOLZA reach temperatures above 86-degrees F (30-degrees C).
Throw away the TRYNGOLZA autoinjector if kept at room temperature longer than 6 weeks.
Do not freeze.
Do not expose TRYNGOLZA autoinjector to heat.
Protect from light.
Keep the TRYNGOLZA autoinjector in the carton until ready to use.
Do not store the autoinjector with the clear cap removed.
Keep TRYNGOLZA and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 12/2024
Prescribing Information: revision date 01/2025
Please call your healthcare provider for more information.
Before using TRYNGOLZA, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if TRYNGOLZA can harm your unborn baby. Tell your healthcare provider if you become pregnant while using TRYNGOLZA.
are breastfeeding or plan to breastfeed. It is not known if TRYNGOLZA passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using TRYNGOLZA.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
