Tryngolza 80 mg solution for injection in Pre-filled pen – patient leaflet, side effects, dosage

1. What Tryngolza is and what it is used for

Tryngolza is a medicine that changes the way in (a so-called lipid-lowering medicine). It contains It is used together with dietary restrictions to help familial chylomicronemia syndrome (FCS). FCS i abnormally high levels of fats called triglycerides the pancreas, causing severe pain, lasting damag Olezarsen works by blocking the production of t

rmation for the user r injection in pre-filled pen

rsen

ring. This will allow quick identification of new y side effects you may get. See the end of

art using this medicine because it contains

gain.

doctor, pharmacist or nurse.

only. Do not pass it on to others. It may harm me as yours.

r, pharmacist or nurse. This includes any See section 4.

ngolza

which the body breaks down fats

the active substance olezarsen.

treat people aged 18 years and above with s an inherited disease that gives rise to in the blood. This can lead to inflammation of e to the pancreas, and can be life threatening. he molecule that slows the removal of

triglycerides. By doing so, it helps to lower the le to reduce the occurrence of acute pancreatitis (i You will only be given Tryngolza if genetic testin Tryngolza may be given after you have already levels of triglycerides in blood and have maintain

2. What you need to know before you use T

Do not use Tryngolza

• if you are allergic to olezarsen or any of the

  section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before following medical problems:

• Any liver or kidney problems.

• A low number of platelets in your blood. Pla

  together to help blood clot.

Allergic reactions

Tryngolza can cause serious allergic reactions. immediately if you develop symptoms of a serio

Children and adolescents

Do not use Tryngolza if you are under 18 years patients under 18 years old and it is not known

Other medicines and Tryngolza

Tell your doctor or pharmacist if you are taking, medicines. Tryngolza can be used with other lipi fibrates.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you a baby, ask your doctor for advice before taking

vels of triglycerides in the blood and can help nflammation of the pancreas).

g has confirmed you have FCS.

received other medicines used to lower the ed a low fat diet without having much effect. ryngolza

other ingredients of this medicine (listed in

using Tryngolza if you have any of the

telets are a type of blood cell which clump

Stop using Tryngolza and contact your doctor us allergic reaction (see section 4).

old. Olezarsen has not been studied in how this medicine will affect them.

have recently taken or might take any other d-lowering medicines, for example statins and

may be pregnant or are planning to have this medicine.

It is not known if this medicine can harm the unb Tryngolza if you are pregnant, think you may be Women who are able to become pregnant shoul It is not known if olezarsen passes into breast mi a breast-feeding newborn/infant. Tell your doctor breast-feed; your doctor will decide if you should what is best for you and your baby.

Driving and using machines

Tryngolza has no or negligible effect on your abil

Sodium

This medicine contains less than 1 mmol sodium essentially ‘sodium-free’.

3. How to use Tryngolza

Always use this medicine exactly as your doctor, your doctor or pharmacist if you are not sure. You should continue the very low-fat diet that yo with Tryngolza.

The recommended dose is 80 mg once a month; t each month.

Tryngolza should be injected under the skin (sub (abdomen), the front of your upper legs, or the b will be trained how to use Tryngolza according to of this leaflet. When injecting this medicine yours your belly or upper legs. Only a healthcare provid the back of your upper arm.

Each single-dose pre-filled pen of this medicine g can only be used once and should be disposed a Before using this medicine, it is important that yo instructions for use provided at the end of this le

orn baby. It is preferable to avoid using pregnant, or are planning to have a baby. d use effective contraception.

lk. It is not known if this medicine can affect if you are breast-feeding or planning to take this medicine or breast-feed based on ity to drive or use machines.

(23 mg) per 80 mg dose, that is to say pharmacist or nurse has told you. Check with ur doctor has recommended during treatment he dose should be given on the same day cutaneous administration) of your belly ack of your upper arms. You or your caregiver the instructions for use provided at the end elf, you can only inject it under the skin of er or caregiver may give you an injection in ives you a dose of 80 mg in 0.8 mL. The pen fter use.

u read, understand, and closely follow the aflet.

Do not use this medicine if the solution appears f it should be a clear and colourless to yellow liqui this is normal.

Do not inject:

• within 2 inches (5 cm) of the belly button.
• into skin that is bruised, tender, red or hard.
• into scars or damaged skin.

If you use more Tryngolza than you should

If you inject too much Tryngolza, contact your do emergency department immediately, even if ther and given supportive care if needed. Bring the m

If you forget to use Tryngolza

If you miss your dose of Tryngolza, inject your ne your monthly injections from then on. If you have contact your doctor, pharmacist or nurse.

If you stop using Tryngolza

Do not stop using Tryngolza unless you have dis If you have any further questions on the use of th nurse.

4. Possible side effects

Like all medicines, this medicine can cause side Serious side effects

Common (may affect up to 1 in 10 people) If you get any of the following side effects, conta

• allergic (hypersensitivity) reactions. These m

  allergic reaction may include difficulty breath lips, mouth, tongue and/or throat, redness of

  rozen, is cloudy, or contains particles; d. You may see air bubbles in the solution, ctor or pharmacist, or attend a hospital e are no symptoms. You will be monitored edicine’s carton or pen with you.

  xt dose as soon as possible, and continue questions about your dosing schedule, cussed this with your doctor.

  is medicine, ask your doctor, pharmacist or effects, although not everybody gets them.

  ct your doctor immediately:

  ay be life-threatening. Symptoms of an ing, throat tightening, swelling of the face, skin, and chills.

  Other side effects

  Very common (may affect more than 1 in 10 peo

  • headache
  • pain, soreness, or stiffness in your joints (arth
  • redness (erythema) at the site of injection
  • being sick (vomiting).

Common (may affect up to 1 in 10 people)

• muscle pain (myalgia)
• change in skin colour at the site of injection
• shivering (chills)
• pain at the site of injection
• swelling at the site of injection.

Reporting of side effects

If you get any side effects, talk to your doctor, pha side effects not listed in this leaflet. You can also Card Scheme, Website: www.mhra.gov.uk/yellowc Google Play or Apple App Store. By reporting side information on the safety of this medicine.

5. How to store Tryngolza

Keep this medicine out of the sight and reach of c Do not use this medicine after the expiry date whi label after ‘EXP’. The expiry date refers to the las Store in a refrigerator (2 °C – 8 °C).

Store in the original package in order to protect fr Tryngolza can also be stored in the original packa up to 6 weeks. If storing Tryngolza outside the ref carton. The disposal date is maximally 6 weeks a refrigerator, and should be noted in the space ind date on the pre-filled pen label or disposal date o

ple)

ralgia)

rmacist or nurse. This includes any possible report side effects directly via the Yellow ard, or search for MHRA Yellow Card in the effects you can help provide more hildren.

ch is stated on the carton and pre-filled pen t day of that month.

om light.

ge outside the refrigerator (up to 30 °C) for rigerator, write the disposal date on the outer fter taking the medicine out of the icated for storage up to 30 °C. If the expiry n the carton has passed, do not use the pre-filled pen and discard it.

Do not throw away any medicines via wastewater to throw away medicines you no longer use. These

6. Contents of the pack and other informatio

What Tryngolza contains

• The active substance is olezarsen. Each sing olezarsen in 0.8 mL solution.
• The other ingredients are sodium dihydrogen phosphate (E339), sodium chloride, water for hydrochloric acid (E507) (see section 2 under

What Tryngolza looks like and contents of the

Tryngolza is a clear, colourless to yellow solution pre-filled pen. Each pre-filled pen contains 0.8 mL Pack size of one pre-filled pen.

Marketing Authorisation Holder

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Manufacturer

Swedish Orphan Biovitrum AB (publ)

Norra Stationsgatan 93

113 64 Stockholm

Sweden

This leaflet was last revised in 03/2026.

or household waste. Ask your pharmacist how measures will help protect the environment. n le-dose pre-filled pen contains 80 mg phosphate (E339), disodium hydrogen injections, sodium hydroxide (E524), ‘Sodium’).

pack for injection in a disposable single-dose solution.

Tryngolza 80 mg solution for injection in pre-filled pen

olezarsen

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INSTRUCTIONS FOR USE

Tryngolza is an injection given under the skin with a disposable single-dose pre-filled pen. Do not use Tryngolza until you completely understand the procedure described below. If you have any questions about how to use Tryngolza, please contact your doctor, pharmacist or nurse.

Plunger

Single-dose pre-filled pen

Medicine

Viewing

window

Clear cap

Orange needle

shield

Alcohol

wipe

Cotton ball or

gauze

Small bandage Sharps container Other supplies (not included)

Get ready to inject Tryngolza

Step 1 Remove from the refrigerator

1. a)

   Remove the pre-filled pen from the

   refrigerator (2 °C – 8 °C).

2. b)

   Keep the pre-filled pen in the original

   carton and let the pre-filled pen reach room

   temperature (up to 30 °C) for 30 minutes

   before injecting.

   30

   minutes Wait

Do not try to speed up the warming process using other heat sources, such as a microwave or hot water.

If you store Tryngolza outside the refrigerator, write the disposal date on the outer carton. The disposal date is maximally 6 weeks after you take the medicine out of the refrigerator, and should be noted in the space indicated for storage up to 30 °C.

Step 2 Inspect the medicine

1. a)

   Check the expiry (‘EXP’) date. Do not use Tryngolza if the ‘EXP’ date or disposal date

   on the carton has passed.

2. b)

   Check the medicine through the viewing window. The medicine should be a clear and

   colorless to yellow liquid. There should be no particles. It is normal to see air bubbles in the solution.

Do not use the pre-filled pen if:

• the clear cap is missing or not attached.

• the expiry (‘EXP’) date or disposal date has

  passed.

• the medicine looks frozen, cloudy, or has

  particles.

• the pre-filled pen appears damaged.

  EXP. MM/YYYY Check

  Step 3 Choose the injection site

  1. a)

     Choose an injection site on the stomach or

     the front of the thigh.

  2. b)

     Only caregivers may inject in the back of

     upper arm.

Do not inject:

• within 2 inches (5 cm) of the belly button.
• into skin that is bruised, tender, red, or hard.

• into scars or damaged skin. thigh

  back

  of the

  upper

  arm

  stomach

  For all For caregivers

  only

Step 4 Wash hands and clean the injection site

The person administering the injection should:

1. a) Wash their hands with soap and water.
2. 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

1. a)

   Hold the pre-filled pen by the middle with

   the clear cap facing away from you.

2. b)

   Remove the clear cap by pulling it straight

   off. Do not twist it off. The needle is inside the orange needle shield.

3. c)

   Throw away the clear cap in the trash or

   sharps container.

   Clear

   cap

   Orange

   needle

   shield

Do not remove the clear cap until right before you inject.

Do not recap the pre-filled pen.

Do not push the orange needle shield against the hand or finger.

Step 6 Begin injection

1. a)

   Hold the pre-filled pen in one hand. Place

   the orange needle shield at a 90-degree angle against your skin. Make sure you can see the viewing window.

2. b)

   Push firmly and hold the pre-filled pen

   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.

90^o click 10sec

1. a) Place b) Push c) Hold
2. c)

   Hold the pre-filled pen 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 pre-filled pen during the injection.

Step 7 Finish injection

1. 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.

2. b)

   Remove the pre-filled pen by lifting it straight up. After removal from the skin, the orange needle shield locks into place and covers the needle.

   Orange plunger rod

3. 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 pre-filled pen.

Throwing away Tryngolza

Step 8 Throw away the pre-filled pen

Put the used pre-filled pen in a sharps container right away after use. Do not throw away the pre-filled pen in your household waste.

Do not recycle your used sharps disposal container.

Do not reuse the pre-filled pen or clear cap.

If you do not have a 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 local laws about how you should throw away used pre-filled pens. Ask your phamacist or see your local public health government website (where available) for more details on how you should dispose of sharps in your location.

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