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Wainzua® 45 mg solution for injection in – patient leaflet, side effects, dosage

Last updated: · Text from the MHRA, as of · About this document

Medicine status: Prescription only (POM) ▼ Additional monitoring Details

Medicine strength:
45 mg (56 mg/ml)
Contains active substance:

Patient leaflet - Wainzua 45 mg solution for injection in Pre-filled pen

1. What Wainzua is and what it is used for

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

What Wainzua is used for

Wainzua is a treatment for adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which runs in families. The illness is caused by problems with a protein called transthyretin (TTR). It is made mostly in the liver and carries vitamin A and other substances around the body.

In people with this illness, small fibres of TTR protein clump together to make deposits called ‘amyloid’. Amyloid can build up around or within the nerves, heart and other places in the body, stopping them from working normally. This widespread nerve damage causes the symptoms of the illness including progressive weakness and loss of sensation in the legs and arms, as well as dizziness, diarrhoea and constipation.

How Wainzua works

Wainzua works by lowering the amount of TTR protein made by the liver. As a result, there is less TTR protein in the blood to form amyloid deposits. That can help to reduce the effects of the illness.

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.

Treatment with Wainzua lowers the amount of vitamin A in your blood. Your doctor will measure your vitamin A levels before treatment.

  • Your doctor will ask you to take a daily vitamin A supplement

    during treatment.

Signs of low vitamin A can include poor vision especially at night, dry eyes, hazy or cloudy vision.

  • Talk to your doctor if you notice problems with vision or

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

You should confirm you are not pregnant before starting treatment with Wainzua. Vitamin A levels affect the development of an unborn child. Women of child-bearing age must practise effective contraception during treatment (see section “Pregnancy, breast-feeding and contraception” below).

  • Tell your doctor if you are planning to become pregnant.

    Your doctor will tell you to stop taking Wainzua and vitamin A supplementation. Your doctor will also ensure that your vitamin A levels have returned to normal before attempting to get pregnant.

  • Tell your doctor if you have an unplanned pregnancy.

    Your doctor will tell you to stop taking Wainzua. In the first 3 months of your pregnancy, your doctor may tell you to stop taking vitamin A supplementation. During the last 6 months of your pregnancy, your doctor may tell you to resume the vitamin A supplementation if your vitamin A levels have not yet returned to normal, because of the increased risk of vitamin A deficiency during the last 3 months of your pregnancy.

Children and adolescents

Wainzua is not recommended in children and adolescents under 18 years of age.

Other medicines and Wainzua

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

Pregnancy, breast-feeding and contraception

If you are pregnant or breastfeeding, think you may be pregnant, or are trying to become pregnant 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 normal development of your unborn child (see “Warnings and precautions” earlier in this leaflet).

  • You should use effective contraception during treatment

    with Wainzua, if you are a woman who is able to become pregnant.

  • Talk to your doctor or nurse about suitable methods of

    contraception.

  • You should confirm you are not pregnant before starting

    treatment with Wainzua.

  • Tell your doctor if you are planning to become pregnant or if

    you are pregnant during treatment. Your doctor will advise you and to stop taking Wainzua.

Pregnancy

You should not use Wainzua if you are pregnant.

Breast-feeding

It is not known whether the active substance of Wainzua can pass into breast milk. A risk to the breastfed child cannot be excluded. Before you start treatment, tell your doctor if you are breast-feeding or planning to breast-feed. Your doctor may tell you to stop taking Wainzua.

Driving and using machines

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

Wainzua contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.8 ml, that is to say essentially ‘sodium-free’.

3. How to use Wainzua

Always use Wainzua exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, nurse, or pharmacist if you are not sure.

Wainzua is given as an injection under the skin (subcutaneously). The injection can be done in the stomach (abdomen), thigh or, if given by a carer, in the back of your upper arm.

You and your doctor or nurse should decide if Wainzua should be injected by yourself or by your carer. You or your carer will receive training on the right way to prepare and inject this medicine. Read the ‘Instructions for Use’ carefully before using it.

The recommended dose of Wainzua is one injection of 45 mg every month.

Your doctor will tell you how long you need to 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, get medical advice immediately, or go to a hospital emergency department. Do this even if you have no symptoms. Bring the medicine’s carton or pen with you.

If you forget to use Wainzua

If you miss your dose of Wainzua, have your next dose as soon as possible and continue your monthly injections from that date on.

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

4. Possible side effects

Like all medicines, Wainzua can have side effects, although not everybody gets them.

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

  • Effects seen in blood tests: low vitamin A (for signs of low

    vitamin A see section “Warnings and precaution” earlier in this leaflet).

Common (may affect up to 1 in 10 people)

  • Vomiting.
  • Redness, itching, pain where the injection was given.
  • Proteinuria.
  • Cataracts.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Wainzua

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

Do not use Wainzua after the expiry date which is stated on the pre-filled pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C).

Store in the original package.

Do not freeze. Do not expose to heat.

Wainzua may be stored unrefrigerated (below 30°C) in the original carton for up to 6 weeks. If not used within 6 weeks unrefrigerated, it should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Wainzua contains

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

The other ingredients are sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate anhydrous, 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).

What Wainzua looks like and contents of the pack

Wainzua is a solution for injection which is clear, colourless to yellow.

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

Marketing Authorisation Holder

AstraZeneca UK Limited

1 Francis Crick Avenue

Cambridge

CB2 0AA

UK

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

This leaflet was last revised in February 2026

© AstraZeneca 2026

WAINZUA is a registered trademark of the AstraZeneca group of companies.

CV 26 0011

Other sources of information

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000

Please be ready to give the following information: Product name Reference number

Eplontersen 45 mg solution for injection in pre-filled pen 17901/0377

This is a service provided by the Royal National Institute of the Blind.

110302228

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PLGB 17901/0377

Last revision stated in the text: February 2026 · MHRA data as of 13 October 2026

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Wainzua 45 mg solution for injection in Pre-filled pen

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Eplontersen
Strength 45 mg (56 mg/ml)
Pharmaceutical form Solution for injection
How is it taken Subcutaneous
Pack sizes 1 pre-filled disposable injection
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Additional monitoring Yes ▼ – new safety information is collected quickly. Report any side effect to the Yellow Card scheme.
Marketing authorisation PLGB 17901/0377
Codes GTIN 5000456084833 · BNF 04070300

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.