This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use WAINZUA 45 mg INJECTABLE SOLUTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Wainzua 45mg solution for injection in pre-filled pen

eplontersen

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

What is Wainzua and what is it used for
What you need to know before you use Wainzua
How to use Wainzua
Possible side effects
Storage of Wainzua
Contents of the pack and other information

1. What is Wainzua and what is it used for

The active substance of Wainzua, eplontersen, is a type of medicine called an antisense oligonucleotide.

Wainzua is used to treat adults with nerve damage throughout the body (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (ATTRv).

In people with ATTRv, the transthyretin (TTR) protein is defective and breaks down easily. This causes it to clump together and form deposits called amyloid deposits, which can build up around or inside nerves and other parts of the body and prevent them from working normally.

Wainzua works by reducing the amount of TTR protein produced by the liver. As a result, there is less TTR protein in the blood to form amyloid deposits, and this can help reduce the symptoms of the disease.

2. What you need to know before you use Wainzua

Do not use Wainzua:

if you are allergic to eplontersen or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

You will need vitamin A supplements during treatment with Wainzua.This medicine reduces the amount of vitamin A in your blood. Your doctor will check your vitamin A levels before treatment.

Your doctor will ask you to take a daily oral vitamin A supplementduring treatment.

Signs of low vitamin A levels can include poor vision, especially at night, dry eyes, blurred or cloudy vision, or eye inflammation (redness, pain, excess tears or other discharges, or a feeling of something in the eye).

Tell your doctor if you notice vision problemsor any other eye problems while using Wainzua. If necessary, your doctor will refer you to an eye specialist for a check-up.

You must confirm that you are not pregnantbefore starting treatment with Wainzua. Both high and low levels of vitamin A can harm the development of the fetus. Women of childbearing age must use effective contraceptive methodsduring treatment with Wainzua (see section "Pregnancy and breastfeeding" later in this leaflet).

Vitamin A levels may remain low for more than 15 weeks after the last dose of Wainzua.
Tell your doctor if you plan to become pregnant.Your doctor will advise you to stop taking Wainzua and the vitamin A supplement. Your doctor will also make sure that your vitamin A levels have returned to normal before you try to become pregnant.
Tell your doctor if you become pregnant unintentionally during treatment.Your doctor will advise you to stop taking Wainzua. In the first 3 months of your pregnancy, your doctor may advise you to stop taking the vitamin A supplement. During the last 6 months of your pregnancy, your doctor may advise you to resume the vitamin A supplement if your vitamin A levels have not returned to normal, due to a higher risk of deficiency during the last 3 months of pregnancy.

Children and adolescents

Wainzua must not be used in children and adolescents under 18 years of age. Its safety and efficacy in this population have not been established.

Other medicines and Wainzua

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Women of childbearing age

Wainzua will reduce the level of vitamin A in your blood, and vitamin A is important for the normal development of the fetus (see section "Warnings and precautions" earlier in this leaflet).

You must use effective contraceptive methodsduring treatment with Wainzua if you are a woman who can become pregnant.
Talk to your doctor or nurse about suitable contraceptive methods.
You must confirm that you are not pregnant before starting treatment with Wainzua.

Tell your doctorif you plan to become pregnant or if you become pregnant during treatment. Your doctor will advise you to stop taking Wainzua.

Pregnancy

Do not use Wainzua if you are pregnant.

Breastfeeding

It is not known whether the active substance of Wainzua can pass into breast milk. The risk to the breastfed child cannot be excluded. If you are breastfeeding or plan to breastfeed, tell your doctor before starting treatment. Your doctor may advise you to stop taking Wainzua.

Driving and using machines

Wainzua is unlikely to affect your ability to drive or use machines. Your doctor will tell you whether your condition allows you to drive and use machines safely.

Wainzua contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, which is essentially "sodium-free".

3. How to use Wainzua

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is one 45 mg injection per month.

Wainzua is given by injection under the skin (subcutaneously). The injection can be given in the stomach area (abdomen) or the top of the thigh. If given by a caregiver or healthcare professional, Wainzua can also be injected into the back of the upper arm. Do not inject the medicine into skin that is bruised, tender, red, or hard, or into scars or damaged skin. Avoid the area around the navel.

You and your doctor or nurse will decide if Wainzua should be injected by you, your caregiver, or a healthcare professional. You or your caregiver will receive training on how to prepare and inject this medicine correctly. Read the "Instructions for use" carefully before using the pre-filled pen (provided in a separate leaflet).

Your doctor will tell you how long you should receive Wainzua. Do not stop treatment unless your doctor tells you to.

If you use more Wainzua than you should

If you inject too much, seek medical attention immediately or go to the emergency department of a hospital. Do this even if you do not have any symptoms. Take the packaging or the pen with you.

If you forget to use Wainzua

If you miss a dose of Wainzua, give the next dose as soon as possible and continue with the monthly injections from then on. Do not give a double dose.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common(may affect more than 1 in 10 people)

Low vitamin A levels seen in blood tests

Common(may affect up to 1 in 10 people)

vomiting
redness (erythema), itching (pruritus), and pain at the injection site

Reporting of side effects

If you experience any side effects, tell your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wainzua

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the pre-filled pen and on the carton after "EXP". The expiry date refers to the last day of the month shown.

Store in a refrigerator(between 2°C and 8°C). Do not freeze.

If necessary, Wainzua can be stored outside of the refrigerator at a temperature below 30°C for a maximum of 6weeksin the original packaging. Discard the medicine if it is not refrigerated and not used within 6 weeks.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Wainzua

The active ingredient is eplontersen. A pre-filled pen contains 45 mg of eplontersen (as eplontersen sodium) in 0.8 ml of solution.

The other ingredients are sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, sodium chloride, and water for injectable preparations. Hydrochloric acid and sodium hydroxide may be used to adjust the pH (see "Wainzua contains sodium" in section 2).

Appearance of Wainzua and Container Contents

Wainzua is a clear, colorless to yellowish injectable solution.

Wainzua is available in a container that contains 1 pre-filled pen for single use.

Marketing Authorization Holder

Astrazeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

België/Belgique/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

Text in Bulgarian language with company name AstraZeneca Bulgaria EOOD and phone number +359 (2) 44 55 000

Luxembourg/Luxemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Ceská republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Magyarország

AstraZeneca Kft.

Tel.: +36 1 883 6500

Danmark

AstraZeneca A/S

Tlf.: +45 43 66 64 62

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

Deutschland

AstraZeneca GmbH

Tel: +49 40 809034100

Nederland

AstraZeneca BV

Tel: +31 85 808 9900

Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00

Ελλάδα

AstraZeneca A.E.

Τηλ: +30 210 6871500

Österreich

AstraZeneca Österreich GmbH

Tel: +43 1 711 31 0

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00

Hrvatska

AstraZeneca d.o.o.

Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35600

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Italia

AstraZeneca S.p.A.

Tel: +39 02 00704500

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Κύπρος

Αλέκτωρ Φαρμακευτική Λτδ

Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

INSTRUCTIONS FOR USE

Wainzua 45 mg Solution for Injection in Pre-filled Pen

(eplontersen)

These instructions for use contain information on how to inject Wainzua 45 mg solution for injection in pre-filled pen.

Read these instructions for use before using the pre-filled pen for the first time and each time you have a new pen. There may be new information.This information does not replace consultation with a healthcare professional about your medical condition or treatment.

A healthcare professional should show you or your caregiver how to use the pre-filled pen correctly. If you or your caregiver have any questions, consult your healthcare professional.

Important Information You Should Know Before Using the Pen

Store Wainzua pen in the refrigerator between 2 °C and 8 °C in the original packaging until ready for use. If necessary, the unopened container can be stored at room temperature up to 30 °C for a maximum of 6 weeks.

Keep the pen in the packaging until the time of use.

Each pen contains 1 dose and can only be used once.

The dose is administered only as a subcutaneous injection.

Do notuse the pen if:

it has been frozen.

it has been dropped, damaged, or appears to have been tampered with.

the expiration date (CAD/EXP) has passed.

Do notshare the pen with anyone.

Keep the pen and all medicines out of the sight and reach of children.

Your Pre-filled Pen

Do notremove the cap until just before injecting.

Do nottouch the orange needle guard.


Preparation for Injection Step 1 – Gather Materials for Your Injection

Step 2 – Remove from Refrigerator and Wait 30 Minutes Keep the pre-filled pen in the packaging for 30 minutes at room temperature, between 20 °C and 25 °C, before injection. Do notheat it in any other way. For example, do notheat it in a microwave, in hot water, or near other heat sources. Keep it away from light or direct sunlight.
Step 3 – Remove the Pre-filled Pen from the Packaging and Inspect Check if the pre-filled pen is damaged. Check the expiration date (CAD/EXP). Check the condition of the liquid through the viewing window. It is normal to see small air bubbles in the liquid. The liquid should be clear and colorless or slightly yellowish. Do notuse it if the liquid is cloudy, has changed color, or contains visible particles.
Injecting with the Pre-filled Pen Step 4 – Choose an Injection Site You or your caregiver can inject into the front of the thigh or the lower stomach (abdomen). A caregiver or healthcare professional can also inject you in the upper back of the arm. Do nottry to inject yourself in the upper arm. For each injection, choose an injection site that is at least 3 cm (1 inch) away from the site where you last injected. Do notinject: in the area of 5 cm (2 inches) around the navel. where the skin is red, hot, sensitive, bruised, scaly, or hardened. in scars, damaged skin, discolored or tattooed skin. through clothing.
Step 5 – Wash Your Hands and Clean the Injection Site Wash your hands well with soap and water. Clean the injection site with an alcohol swab or with soap and water. Let it air dry.
Do nottouch the cleaned area before injection.
Step 6 – Remove the Cap Hold the pen body with one hand and carefully pull the transparent cap with the other hand. The orange needle guard is now exposed and the needle is hidden underneath. Discard the transparent cap. Do nottouch the needle or push the orange needle guard with your finger.
Do notput the cap back on the pre-filled pen. This could cause the medicine to come out too soon or damage the pre-filled pen.
Step 7 – Injection Inject using the pre-filled pen following the steps in figures a, b, c, and d. When injecting, hold the pen firmly for 10 seconds until the orange plunger fills the viewing window completely. You may hear a first "click" at the start of the injection and a second "click" at the end of the injection. This is normal. Do notmove or change the position of the pre-filled pen after the injection has started.
	Position the Pre-filled Pen. Place the orange needle guard flat against the skin (at a 90-degree angle). Make sure you can see the viewing window.

Press Down Firmly and Hold. You may hear the first "click"immediately, this indicates that the injection has started. The orange plunger will move down in the viewing window.	Hold Firmly for About 10 Seconds. The orange plunger will fill the viewing window completely. You may hear the second "click"at the end of the injection.	Once the Injection is Complete, Lift the Pen Upwards. The orange needle guard will slide down and lock, covering the needle.
Step 8 – Check the Viewing Window Check the viewing window to make sure all the medicine has been injected. If the orange plunger does not fill the viewing window completely, you may not have received the full dose. If this happens or you have any other concerns, contact your doctor or healthcare professional.

Step 9 – Check the Injection Site There may be a small amount of blood or liquid at the injection site. This is normal. If necessary, press a cotton ball or gauze on the area and apply a small bandage.
Step 10 – Dispose of the Used Pre-filled Pen Place the used pen in a puncture-resistant sharp objects containerimmediately after use. Do notthrow the pen in the household trash.
Disposal Guidelines Dispose of the filled container as instructed by a healthcare professional or pharmacist. Do notrecycle your used sharp objects container.