Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

TRYNGOLZA (AUTOINJECTOR) (NDA-218614)

(OLEZARSEN SODIUM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/24/2026 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypersensitivity Reactions

Additions and/or revisions underlined:

Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been reported in patients treated with TRYNGOLZA [see Adverse Reactions (6.1)]. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.

5.2 Liver Enzyme Abnormalities

Newly added subsection:

TRYNGOLZA can cause increases in liver enzymes and hepatic fat in adults [see Adverse Reactions (6.1)].

Increases in liver enzymes were more frequently reported with the 80 mg dose as compared to the 50 mg dose. In patients with sHTG, increases in liver enzymes greater than or equal to three times the upper limit of normal were reported more frequently with TRYNGOLZA 80 mg (7%) compared to TRYNGOLZA 50 mg (3%) and placebo (3%).

Consider liver enzyme testing before TRYNGOLZA initiation or an increase in dosage and when clinically indicated thereafter. If persistent elevations in liver enzymes occur (such as three times the upper limit of normal or greater), consider dose interruption and/or dose reduction. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue TRYNGOLZA.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Liver Enzyme Abnormalities [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Risk Summary

There are no available data on TRYNGOLZA use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS or sHTG are at risk for pancreatitis during pregnancy because of increased TG levels (see Clinical Considerations).

…

8.5 Geriatric Use

Additions and/or revisions underlined:

No dose adjustment is recommended in patients aged 65 years and older [see Clinical Pharmacology (12.3)]. In clinical trials, 243 patients treated with TRYNGOLZA were ?65 years of age. No overall differences in safety or effectiveness of TRYNGOLZA have been observed between patients 65 years of age and older and younger adult patients.

8.7 Hepatic Impairment

Additions and/or revisions underlined:

No dose adjustment is recommended in patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3)]. TRYNGOLZA has not been studied in patients with severe hepatic impairment.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Liver Enzyme Abnormalities

Inform patients that TRYNGOLZA may cause liver enzyme elevations. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.2)].

Adherence to Diet

Advise patients to maintain a low-fat diet in conjunction with TRYNGOLZA. Instruct patients with FCS to consume 20 g of fat or less per day [see Dosage and Administration (2)].

PATIENT INFORMATION

Additions and/or revisions underlined:

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).

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).

…

How should I use TRYNGOLZA?

…

Stay on your low-fat diet (less than 20 grams of fat each day if you have FCS) while using TRYNGOLZA.

What are the possible side effects of TRYNGOLZA?

…

Liver problems: 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 of liver problems:

feeling tired or weak o loss of appetite
right upper stomach discomfort
dark colored urine
yellowing of the skin and eyes

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)

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)

increased liver enzymes

…