Patient information: uses, side effects, how to take - Tryngolza

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).

It is not known if TRYNGOLZA is safe and effective in children.

Do not use TRYNGOLZA if:

you have had a serious allergic reaction to olezarsen or any of the ingredients in TRYNGOLZA. See the end of this Patient Information for a complete list of ingredients.

Before using TRYNGOLZA, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if TRYNGOLZA can harm your unborn baby. Tell your healthcare provider if you become pregnant while using TRYNGOLZA.
are breastfeeding or plan to breastfeed. It is not known if TRYNGOLZA passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using TRYNGOLZA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use TRYNGOLZA?

Read the detailed Instructions for Use that comes with your TRYNGOLZA single-dose autoinjector.
Your healthcare provider will show you or your caregiver how to inject TRYNGOLZA the first time.
TRYNGOLZA is injected under your skin (subcutaneous use) in your stomach area (abdomen) or the front of your upper legs (thighs). Only a healthcare provider or caregiver may give you an injection in the back of your upper arm.
TRYNGOLZA should be injected 1 time each month.
If you miss a dose, take the missed dose as soon as possible. Then inject TRYNGOLZA 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your dosing schedule, ask your healthcare provider.
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?

Allergic reactions: 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.
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
- 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

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.

How should I store TRYNGOLZA?

Store TRYNGOLZA autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.
TRYNGOLZA can also be stored at room temperature between 59°F to 86°F (15°C to 30°C) in the original carton for up to 6 weeks.
Do not let TRYNGOLZA reach temperatures above 86°F (30°C).
Throw away the TRYNGOLZA autoinjector if kept at room temperature longer than 6 weeks.
Do not expose TRYNGOLZA autoinjector to heat.
Protect from light.
Keep the TRYNGOLZA autoinjector in the carton until ready to use.
Do not store the autoinjector with the clear cap removed.

Keep TRYNGOLZA and all medicines out of the reach of children.

General information about the safe and effective use of TRYNGOLZA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use TRYNGOLZA for a condition for which it was not prescribed. Do not give TRYNGOLZA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TRYNGOLZA that is written for health professionals.

What are the ingredients in TRYNGOLZA?

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.

Distributed by: Ionis Pharmaceuticals, Inc., Carlsbad, CA 92010

TRYNGOLZA is a registered trademark of Ionis Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

For more information, go to www.TRYNGOLZA.com or call 1-833-644-6647. If you still have questions, contact your healthcare provider.

INSTRUCTIONS FOR USE TRYNGOLZA ^®[trin-GOLE-zah] (olezarsen) injection, for subcutaneous use Single-dose autoinjector 50 mg/0.8 mL and 80 mg/0.8 mL
This Instructions for Use has been approved by the U.S. Food and Drug Administration		Revised: 06/2026
This Instructions for Use contains information on how to inject TRYNGOLZA ^®using the autoinjector.
Read this Instructions for Use before you start using your TRYNGOLZA autoinjector and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to use the TRYNGOLZA autoinjector the right way. If you or your caregiver have any questions, talk to your healthcare provider.

Important information: TRYNGOLZA is injected under the skin (subcutaneous use) only. Each autoinjector contains 1 single-dose and can only be used 1 time. Do not remove the clear cap until you are ready to inject TRYNGOLZA (See Step 5). Do not share your autoinjector with anyone. Do not use if the autoinjector appears damaged.
Storage information: Store the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton. TRYNGOLZA can also be stored at room temperature between 59°F to 86°F (15°C to 30°C) in the original carton for up to 6 weeks. Do not let TRYNGOLZA reach temperatures above 86°F (30°C). Throw away the TRYNGOLZA autoinjector if kept at room temperature longer than 6 weeks. Do not expose the autoinjector to heat. Protect from light. Keep the autoinjector in the carton until ready to use. Do not store the autoinjector with the clear cap removed.
Keep TRYNGOLZA and all medicine out of the reach of children.
Parts of your TRYNGOLZA autoinjector
Single-dose autoinjector
Other supplies (not included)	Alcohol wipe	Sharps container
	Cotton ball or gauze	Small bandage
Preparing to inject TRYNGOLZA
Step 1 Remove from the refrigerator a) Remove the autoinjector from the refrigerator.
b) Keep the autoinjector in the original carton and let the autoinjector come to room temperature for 30 minutes before injecting.
Do not try to speed up the warming process using other heat sources, such as a microwave or hot water.
Step 2 Check the medicine
a) Check the expiration (EXP) date.
b) Check the medicine through the viewing window. The TRYNGOLZA medicine should be clear and colorless to yellow. There should be no particles. It is normal to see air bubbles in the solution.
Do not use the autoinjector if the: clear cap is missing or not attached. expiration (EXP) date has passed. medicine looks cloudy, discolored, or has particles. autoinjector appears damaged.
Step 3 Choose the injection site
a) Choose an injection site on the stomach or the front of the thigh.
b) Only your healthcare provider or caregivers may choose the back of upper arm.
Do not inject: within 2 inches (5 cm) of the belly button (navel). into skin that is bruised, tender, red, or hard. into scars or damaged skin.
Step 4 Wash hands and clean the injection site
a) Wash your hands with soap and water.
b) Clean the injection site with an alcohol wipe in a circular motion. Let the skin air dry.
Do not touch the cleaned skin before injecting.
Injecting TRYNGOLZA
Step 5 Remove and throw away the clear cap
a) Hold the autoinjector by the middle with the clear cap facing away from you.
b) Remove the clear cap by pulling it straight off. Do not twist it off. The needle is inside the orange needle shield.
c) Throw away the clear cap in the trash or sharps container.
Do not remove the clear cap until right before you inject. Do not recap the autoinjector. Do not push the orange needle shield against the hand or finger.
Step 6 Begin injection
a) Hold the autoinjector in 1 hand. Place the orange needle shield at a 90-degree angle against your skin. Make sure you can see the viewing window.
b) Push firmly and hold the autoinjector straight against the skin. You will hear a click as the injection starts.
You may hear a second click. This is normal. The procedure is not finished.
c) Hold the autoinjector against the skin for 10 seconds to make sure the full dose has been given.
Do not move, turn, or change the angle of the autoinjector during the injection.
Step 7 Finish injection
a) Check that the orange plunger rod has moved down to fill the entire viewing window. If the orange plunger rod does not fill the viewing window, you may not have received the full dose. If this happens or if you have other concerns, contact your healthcare provider.
b) Remove the autoinjector by lifting it straight up. After removal from the skin, the orange needle shield locks into place and covers the needle.
c) There may be a small amount of blood or liquid where you injected. This is normal.
If needed, press a cotton ball or gauze on the area and apply a small bandage.
Do not reuse the autoinjector.
Throwing away TRYNGOLZA
Step 8 Throw away autoinjector
a) Put the used autoinjector in a sharps container right away after use.
Do not throw away the autoinjector in your household trash. Do not recycle your used sharps disposal container. Do not reuse the autoinjector or clear cap.
If you do not have an FDA-cleared sharps container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labelled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used autoinjectors.
For more information about safe sharps disposal, and specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not throw away your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
For more information, go to https://www.TRYNGOLZA.comor call 1-833-644-6647. If you still have questions, contact your healthcare provider.
Distributed by: Ionis Pharmaceuticals, Inc., Carlsbad, CA 92010