Some clinical trial participants experienced
side effects while taking TRYNGOLZA
The safety of TRYNGOLZA was studied in 66 participants with FCS in the clinical trial with 23 participants receiving placebo. Side effects were reported among 22 participants who took TRYNGOLZA 80 mg once monthly and followed a low-fat FCS diet, and 21 who took TRYNGOLZA 50 mg once monthly and followed a low-fat FCS diet. TRYNGOLZA 80 mg is the only FDA-approved and available dose.
Do not use TRYNGOLZA if:
- You have had a serious allergic reaction to olezarsen or any of the ingredients in TRYNGOLZA. See the Patient Information for a complete list of ingredients
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.
In the clinical trial, the most common side effects with TRYNGOLZA were:
Adverse reactions occurred in >5% of participants treated with TRYNGOLZA and at >3% higher frequency than placebo.
- Injection-site reactions (such as redness or pain at the injection site): 19% of participants taking TRYNGOLZA vs 9% taking placebo
- Decreased platelet count (blood cells that help to clot blood): 12% of participants taking TRYNGOLZA vs 4% taking placebo
- Joint pain or stiffness: 9% of participants taking TRYNGOLZA vs 0% taking placebo
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.
Not a real patient; actor portrayal.
Before starting TRYNGOLZA, it is important to talk to your doctor about all the benefits and
risks associated with taking TRYNGOLZA.
Stay on your low-fat diet (less than 20 grams of fat each day) while using TRYNGOLZA.
FCS=familial chylomicronemia syndrome.