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Important safety information
Do not use TRYNGOLZA if you have had a serious allergic reaction to TRYNGOLZA or any of the ingredients in TRYNGOLZA.
Before using TRYNGOLZA, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. It is not known if TRYNGOLZA can harm your unborn baby, or if it passes into your breast milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TRYNGOLZA?
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.
TRYNGOLZA can cause increases in liver enzymes and fat stored inside the liver. Your healthcare provider may do liver tests before you start taking TRYNGOLZA or if there is an increase in your dose. Tell your healthcare provider right away if you have the following symptoms: feeling tired or weak, right upper stomach discomfort, yellowing of the skin and eyes, loss of appetite, or dark colored urine.
The most common side effects of TRYNGOLZA in people with FCS include injection site reactions (such as redness, itching, rash, or pain at the injection site), decreased platelet count (blood cells that help to clot blood), and joint pain or stiffness.
The most common side effects of TRYNGOLZA in people with sHTG include injection site reactions (such as redness, itching, rash, or pain at the injection site) and increased liver enzymes.
These are not all the possible side effects of TRYNGOLZA. Tell your healthcare provider or treatment team about any side effect you may have.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call
1-800-FDA-1088.
INDICATIONS
TRYNGOLZA (olezarsen) 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).
- Reduce triglycerides and reduce the risk of acute inflammation of your pancreas (pancreatitis) in the treatment of adults with a condition marked by very high levels of triglycerides in the blood called severe hypertriglyceridemia (sHTG).
It is not known if TRYNGOLZA is safe and effective in children.
Please see full Prescribing Information and Patient Information for TRYNGOLZA.