Wainzua 45 mg solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Wainzua 45mg solution for injection in a pre-filled pen

eplontersen

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report side effects.

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and must not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Wainzua is and what it is used for
2. What you need to know before using Wainzua
3. How to use Wainzua
4. Possible side effects
5. How to store Wainzua
6. Contents of the pack and other information

1. What Wainzua is and what it is used for

The active substance in 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 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 known as amyloid deposits, which can accumulate around or within nerves and in other parts of the body, interfering with their normal function.

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

2. What you need to know before starting to use Wainzua

Do not use Wainzua:

• if you are allergic to eplontersen or to 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 the blood. Your doctor will check your vitamin A levels before treatment begins.

• Your doctor will instruct you to take an oral vitamin A supplement daily during treatment.

Signs of low vitamin A levels may include poor vision, especially at night, dry eyes, blurred or cloudy vision, or ocular inflammation (redness, pain, excessive tearing or other secretions, or a sensation of having something in the eye).

• Consult your doctor if you notice vision problems or any other eye problems while using Wainzua. If necessary, your doctor will refer you to an ophthalmologist for evaluation.

You must confirm that you are not pregnant before starting treatment with Wainzua. Both excessively high and low levels of vitamin A can harm fetal development. Women of childbearing potential must use effective contraceptive methods during 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.
• Inform your doctor if you plan to become pregnant. Your doctor will instruct you to stop taking Wainzua and the vitamin A supplement. Your doctor will also ensure that your vitamin A levels have returned to normal before you attempt to become pregnant.
• Inform your doctor of any unplanned pregnancy during treatment. Your doctor will instruct you to stop taking Wainzua. During the first 3 months of pregnancy, your doctor may instruct you to stop taking the vitamin A supplement. During the last 6 months of pregnancy, your doctor may instruct you to resume the vitamin A supplement if your vitamin A levels have not yet returned to normal, due to the increased risk of vitamin 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 have not been established in this population.

Other medicines and Wainzua

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Women of childbearing potential

Wainzua will reduce your blood vitamin A levels, and vitamin A is important for normal fetal development (see section "Warnings and precautions" above in this leaflet).

• You must use effective contraceptive methods during treatment with Wainzua if you are a woman who could become pregnant.

• Discuss appropriate contraceptive methods with your doctor or nurse.

• You must confirm that you are not pregnant before starting treatment with Wainzua.

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

Pregnancy

You must not use Wainzua if you are pregnant.

Breastfeeding

It is unknown whether the active substance of Wainzua passes into breast milk. Risk to the breastfed infant cannot be excluded. Before starting treatment, inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor may advise you to stop taking Wainzua.

Driving and use of machines

It is unlikely that Wainzua will affect your ability to drive or operate machinery. Your doctor will advise you whether your condition allows you to drive or operate machinery safely.

Wainzua contains sodium

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

3. How to use Wainzua

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 45 mg injection once a month.

Wainzua is administered by subcutaneous injection (under the skin). The injection may be given in the abdominal area (abdomen) or in the upper thigh. If administered by a caregiver or healthcare professional, Wainzua may also be given in the back of the upper arm. Do not inject the medicine into bruised, tender, red, or hardened skin, or into scars or damaged skin. The area around the navel should be avoided.

You and your doctor or nurse will decide whether Wainzua should be injected by yourself, by your caregiver, or by a healthcare professional. You or your caregiver will receive training on the correct way to prepare and inject this medicine. 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 instructed by your doctor.

If you use more Wainzua than you should

If you inject too much, seek immediate medical attention or go to a hospital emergency department. 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 your dose of Wainzua, administer the next dose as soon as possible and continue with your monthly injections from that point onward. Do not administer a double dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Low levels of vitamin A observed 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 adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the label of the pre-filled pen and on the outer packaging, after "CAD/EXP". The expiry date refers to the last day of the month indicated.

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

If necessary, Wainzua may be stored outside the refrigerator at a temperature below 30°C for up to 6 weeks in the original packaging. Discard the medicine if it has been unrefrigerated and not used within 6 weeks.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Wainzua

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

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

Appearance of Wainzua and contents of the pack

Wainzua is a clear, colourless to yellow, injectable solution.

Wainzua is available in a pack containing 1 single-use, pre-filled pen.

Marketing Authorisation Holder

Astrazeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine 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 provide information on how to inject Wainzua 45 mg solution for injection in a pre-filled pen.

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

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

Important information you should know before using the pen

Store Wainzua pre-filled pen in the refrigerator at 2 °C to 8 °C in the original packaging. If necessary, the unopened package may be stored at room temperature up to 30 °C for a maximum of 6 weeks.

Keep the pen in its packaging until ready to use.

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

The dose is administered only as a subcutaneous injection (under the skin).

Do not use the pen if:

it has been frozen.

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

the expiry date (EXP/CAD) has passed.

Do not share the pen with anyone.

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

Your pre-filled pen

Do not remove the cap until just before administering the injection.

Do not touch the orange needle shield.