Tryngolza
Pronunciation: trin-GOLE-zah
Generic name: olezarsen
Dosage form: single-dose autoinjector (80 mg/0.8 mL)
Drug class: Miscellaneous antihyperlipidemic agents
What is Tryngolza?
Tryngolza (olezarsen) is used to reduce high triglyceride levels in adults with familial chylomicronemia syndrome (FCS), a rare genetic disorder. It is administered once-monthly via subcutaneous (under the skin) injection and must be used in combination with a low-fat diet that contains no more than 0.7 ounces (20 grams) of fat per day.
How Tryngolza Works for FCS Patients: Mechanism
Tryngolza (olezarsen) belongs to the drug class called ASO-GalNAc3 conjugates. This FCS medication works by:
- Reducing apoC-III protein levels produced by the liver. This protein plays a key role in breaking down triglycerides.
- Targeting and breaking down genetic instructions (mRNA) that produce apoC-III.
- Improving the body's ability to remove triglycerides and VLDL cholesterol from the blood.
- Preventing acute pancreatitis levels associated with extremely high triglycerides.
FDA approval and Clinical Trial Results
Tryngolza (olezarsen) received FDA approval on December 19, 2024, as the first approved FCS treatment. Manufactured by Ionis Pharmaceuticals Inc., this approval was based on results from the BALANCE clinical trial (NCT04568434), a Phase 3 randomized, placebo-controlled study involving 66 FCS patients.
Clinical Trial Efficacy Results:
- 42% triglyceride reduction at 6 months
- 57-59% reduction at 12 months
- 100% reduction in acute pancreatitis events
- Significant improvement in FCS symptom management.
Tryngolza Side Effects
Common side effects
The most common side effects of Tryngolza are:
- Injection site reactions, such as redness or pain at the injection site
- Decreased platelet counts (blood cells that help clot blood)
- Joint pain or stiffness.
Serious side effects and warnings
Tryngolza may cause an allergic reaction that could 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.
It is not known if Tryngolza is safe and effective in children.
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.
Related/similar drugs
Contraindications for FCS Treatment
Do not use Tryngolza if you have:
- History of serious allergic reactions to olezarsen or Tryngolza
- Known allergies to any inactive ingredients in the formulation.
Before taking
Before using Tryngolza, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy and Breastfeeding Considerations
- Pregnancy: Safety during pregnancy is unknown. Discuss with your healthcare provider.
- Breastfeeding: Unknown if Tryngolza passes into your breast milk. Consult your doctor about feeding options while using this FCS treatment.
How do I use Tryngolza?
Tryngolza should be injected 1 time a month.
- Tryngolza is injected under your skin (subcutaneously).
- Stay on your low-fat diet (less than 20 grams of fat per day) while using Tryngolza.
How to Use the Tryngolza Autoinjector
- Your healthcare provider will demonstrate proper injection technique
- Use the single-dose autoinjector as instructed
- Rotate injection sites to prevent skin irritation
- Follow the detailed Instructions for Use included with your medication.
Tryngolza Dosing Information
Recommended FCS Treatment Dosage
- Adult: 80 mg by subcutaneous injection once monthly.
- Administration sites: Abdomen, front of upper thighs, or back of upper arm (healthcare provider only)
- Treatment schedule: Same date each month for consistent FCS management.
Required Low-Fat Diet with Tryngolza
Strict Dietary Requirements for FCS Treatment
Tryngolza must be combined with an extremely restrictive low-fat diet limiting fat intake to no more than 20 grams per day (0.7 ounces). This dietary restriction is crucial for optimal FCS treatment effectiveness.
Understanding Your 20-Gram Fat Limit
Foods that exceed or use most of your daily fat allowance:
- 1 tablespoon of olive oil = 14 grams of fat
- 1 medium avocado = 21 grams of fat (exceeds daily limit)
- 1 handful of almonds (1 oz) = 14 grams of fat
- 1 tablespoon of butter = 12 grams of fat.
FCS-friendly food options:
- 3 oz of skinless chicken breast = 3 grams of fat
- 2 large eggs = 10 grams of fat
- 1 slice of cheese = 6 grams of fat
Sample daily meal plan within 20 20-gram fat limit:
- Small amount of cooking oil (1-2 teaspoons) = 5-10 grams of fat
- Skinless chicken breast = 3 grams of fat
- A single egg = 5 grams of fat
- Remaining grams from other foods throughout the day that are very low in fat, such as vegetables, most fruits, fish, oats, rice, and whole-grain pasta.
Missed Doses
If you miss a Tryngolza dose:
- Take the missed dose as soon as possible
- Resume your monthly schedule from your last injection date
- Contact your healthcare provider with scheduling questions.
What other medicines can affect Tryngolza?
Drug interaction considerations:
- Inform your healthcare providers about all your medications
- Include prescription drugs, over-the-counter medicines, vitamins, and herbal supplements
- Maintain an updated medication list for all healthcare appointments.
Storage and Handling Instructions
Proper Tryngolza Storage Requirements
Refrigerated storage (preferred):
- Store between 36°F to 46°F (2°C to 8°C)
- Keep in the original carton to protect from light.
Room temperature storage:
- Between 59°F to 86°F (15°C to 30°C) in the original carton
- Maximum 6 weeks at room temperature
- Discard if stored at room temperature longer than 6 weeks.
Important storage reminders:
- Never freeze Tryngolza.
- Protect from heat and light. Do not exceed 86°F (30°C).
- Keep the autoinjector cap on until use.
- Store safely away from children.
Tryngolza Ingredients and Manufacturing
Active and Inactive Ingredients
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.
Available formulation: Single-dose autoinjector containing 80 mg/0.8 mL.
Manufacturer Information
Tryngolza is manufactured by Ionis Pharmaceuticals Inc., located in Carlsbad, California. As the developer of this FCS treatment, Ionis Pharmaceuticals specializes in antisense oligonucleotide therapeutics for rare diseases.
More about Tryngolza (olezarsen)
- Compare alternatives
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antihyperlipidemic agents
- En español
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.