Brand Name
Tryngolza
Generic Name
Olezarsen
View Brand Information FDA approval date: December 19, 2024
Form: Injection
What is Tryngolza (Olezarsen)?
TRYNGOLZA is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome . TRYNGOLZA is an APOC-III -directed antisense oligonucleotide indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome .
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Related Clinical Trials
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
Summary: The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
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Brand Information
TRYNGOLZA (olezarsen sodium)
1INDICATIONS AND USAGE
TRYNGOLZA is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
2DOSAGE FORMS AND STRENGTHS
Injection: 80 mg/0.8 mL of olezarsen as a clear, colorless to yellow solution in a single-dose autoinjector.
3CONTRAINDICATIONS
TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA. Hypersensitivity reactions, including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias, requiring medical treatment have occurred
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of TRYNGOLZA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TRYNGOLZA was evaluated in 66 patients with FCS enrolled in Trial 1 (NCT #04568434)
Adverse reactions led to discontinuation of treatment in 7% of TRYNGOLZA-treated patients and 0% of placebo-treated patients. The most common reasons for TRYNGOLZA treatment discontinuation were hypersensitivity reactions. Adverse reactions (>5% of patients treated with TRYNGOLZA and at >3% higher frequency than placebo) are presented in Table 1.
Table 1. Adverse Reactions That Occurred in >5% of Patients Treated with TRYNGOLZA and at >3% Higher Frequency than Placebo (Trial 1)
5DESCRIPTION
Olezarsen is an ASO directed inhibitor of Apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three
TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer. The molecular formula of olezarsen sodium is C
The structure of olezarsen sodium is presented below:
TRYNGOLZA is a sterile, preservative-free solution for subcutaneous injection. Each single-dose autoinjector contains 80 mg olezarsen (equivalent to 84 mg of olezarsen sodium) in 0.8 mL of solution. The solution also contains the following 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 between 6.9 to 7.9. Each dose of TRYNGOLZA injection contains 6 mg of phosphorous and 5 mg of sodium.
6CLINICAL STUDIES
-The efficacy of TRYNGOLZA was demonstrated in a randomized, placebo-controlled, double-blind clinical trial in adult patients with genetically identified FCS and fasting triglyceride (TG) levels ≥880 mg/dL (Trial 1;
Patient demographic and baseline characteristics were generally similar across the treatment groups
The primary endpoint was percent change in fasting triglycerides from baseline to Month 6 (average of Weeks 23, 25, and 27) compared to placebo. The difference between TRYNGOLZA 80 mg group and the placebo group in percent change in fasting triglycerides from baseline to Month 6 was -42.5% (95% CI: -74.1%, -10.9%; p=0.0084). For additional results see Table 2.
Table 2. Mean Baseline (BL) and Mean Percent (%) Changes from Baseline in Lipid/ Lipoprotein Parameters in Patients with FCS at Month 6 in Trial 1
Median percent change from baseline (Figure 1) and median absolute TG values (Figure 2) over time demonstrated a consistent lowering effect during the 12-month treatment period.
Figure 1. Percent Change in Fasting Triglyceride (mg/dL) Over Time
Figure 2. Fasting Triglyceride (mg/dL) Over Time
Over the 12-month treatment period, the numerical incidence of acute pancreatitis in patients treated with TRYNGOLZA 80 mg was lower compared with placebo [1 (5%) patient in the TRYNGOLZA 80 mg group compared with 7 (30%) patients in the placebo group]; all of these patients had a prior history of pancreatitis within 10 years prior to screening.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
8PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Autoinjector Carton
Tryngolza™
For subcutaneous use
Each TRYNGOLZA autoinjector contains 80 mg
IONIS
NDC 71860-101-01
Rx Only
Discard after ____ / ____ / ____
