Amvuttra 25 mg solucion inyectable en jeringa precargada

Patient Information Leaflet

Amvuttra 25 mg pre-filled syringe

vutrisirán

This medicine is subject to additional monitoring, which will help speed up the detection of any new information about its safety. You can contribute by reporting any side effects you may experience. The final part of section 4 includes information on how to report these side effects.

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

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

1.What is Amvuttra and what is it used for

2.What you need to know before using Amvuttra

3.How to use Amvuttra

4.Possible side effects

5.Storage of Amvuttra

6. Contents of the pack and additional information

The active ingredient of Amvuttra is vutrisirán.

What Amvuttra is used for

Amvuttra is used for the treatment of a disease called “ATTR hereditary” or “amiloidosis ATTRh”. It is a hereditary disease. Amiloidosis ATTRh is caused by problems with a protein in the body called “transtiretina” (TTR). This protein is formed mainly in the liver and transports vitamin A and other substances throughout the body.

In people with this disease, small fibers of the TTR protein aggregate to form deposits called “amyloid”. Amyloid can accumulate around nerves, the heart, and other parts of the body or inside them and prevent them from functioning normally. This causes the symptoms of the disease.

How Amvuttra works

Amvuttra works by reducing the amount of TTR protein produced by the liver, which means there is less TTR protein in the blood that can form amyloid. This may help reduce the effects of this disease.

Amvuttra is only used in adults.

No use Amvuttra

• if you have ever had a severe allergic reaction to vutrisirán or any of the other components of this medication (listed in section 6).

If you are unsure, consult your doctor, pharmacist, or nurse before using this medication.

Warnings and precautions

Reduced levels of vitamin A in the blood and vitamin supplements

Amvuttra reduces the amount of vitamin A in the blood.

Your doctor will ask you to take a vitamin A supplement daily. Take the recommended dose of vitamin A as advised by your doctor.

The signs of low vitamin A levels may include: vision problems, especially at night, dry eyes, or blurred vision.

• If you notice any change in your vision or any other eye problem while using Amvuttra, consult your doctor. Your doctor may refer you to an ophthalmologist for a review.

Very high or very low levels of vitamin A may harm the fetus. Therefore, pregnancy should be excluded in women of childbearing age before starting treatment with Amvuttra and effective contraceptive methods should be used (see the section “Pregnancy, breastfeeding, and contraception” below).

• Vitamin A levels may remain low for more than 12 months after the last dose of Amvuttra.
• Inform your doctor if you plan to become pregnant. Your doctor will advise you to stop taking Amvuttra and the vitamin A supplement. Your doctor will also ensure that your vitamin A levels have returned to normal before attempting to become pregnant.
• Inform your doctor in case of an unplanned pregnancy. Your doctor will advise you to stop taking Amvuttra. During the first 3 months of pregnancy, your doctor may advise you to stop taking the vitamin A supplement. During the last 6 months of pregnancy, your doctor may advise you to resume the vitamin A supplement if your vitamin A levels in the blood have not yet returned to normal, due to a higher risk of deficiency of this vitamin during the last 3 months of pregnancy.

Children and adolescents

Amvuttra is not recommended for children and adolescents under 18 years of age.

Other medications and Amvuttra

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and contraception

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

Pregnancy

Do not use Amvuttra if you are pregnant.

Women of childbearing age

Amvuttra will reduce the level of vitamin A in your blood, which is important for the normal development of the fetus (see “Warnings and precautions” above).

• If you are a woman who may become pregnant, you should use an effective contraceptive method during treatment with Amvuttra.
• Consult your doctor or nurse about suitable contraceptive methods.
• Pregnancy should be excluded before starting treatment with Amvuttra.
• Inform your doctor if you intend to become pregnant or in case of an unplanned pregnancy. Your doctor will advise you to stop taking Amvuttra.

Breastfeeding

The passage of vutrisirán into breast milk is unknown. Your doctor will weigh the potential benefits of treatment for you against the risks to the baby.

Driving and operating machinery

It is believed that the influence of Amvuttra on the ability to drive or operate machinery is negligible or insignificant. Your doctor will tell you if your condition allows you to drive vehicles and use machinery safely.

Amvuttra contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; this is essentially “sodium-free”.

Amvuttra can be self-administered or administered by a caregiver or a healthcare professional.

Your doctor or healthcare professional will show you and/or your caregiver how to prepare and inject a dose of Amvuttra before you do it yourself.

To learn how to use Amvuttra, read the “Instructions for Use” at the end of this prospectus.

How Much Amvuttra to Use

The recommended dose is 25 mg once every 3 months.

Where to Administer the Injection

Amvuttra is administered via subcutaneous injection under the skin in the abdominal area, in the upper arm (if administered by someone else) or in the thigh.

How Long to Use Amvuttra

Your doctor will tell you how long you need to use Amvuttra. Do not stop treatment with Amvuttra unless your doctor tells you to.

Using More Amvuttra Than You Should

In the unlikely event that you use too much (an overdose), contact your doctor or pharmacist, even if you do not have symptoms. Your doctor will check for any adverse effects.

Missing a Dose of Amvuttra

If you forget a dose, administer Amvuttra as soon as possible. Then, resume administration every 3 months, counting from the most recently administered dose.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Very Common:may affect more than 1 in 10people

• Joint pain
• Pain in arms and legs

Common:may affect up to 1 in 10people

• Shortness of breath
• Redness, pain, itching, rashes, or heat at the injection site
• Blood tests showing increases in a liver enzyme called alkaline phosphatase

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse,even if it is possible adverse effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label, on the blister pack, and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above30°C.

Do not freeze.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Amvuttra

• The active principle is vutrisiran.

Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg of vutrisiran in 0.5 ml of solution.

• The other components are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, and water for injection. It can be used with sodium hydroxide and phosphoric acid to adjust the pH (see “Amvuttra contains sodium” in section 2).

Appearance of the product and contents of the pack

This medicinal product is a transparent, colourless to yellowish injectable solution. Each pack contains a pre-filled syringe for single use.

Marketing authorisation holder and responsible manufacturer

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics: 02/2025

Other sources of information

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

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Instructions for use

Amvuttra 25 mg solution for injection in pre-filled syringe

vutrisiran

Pre-filled syringe for single use with needle shield

Read these instructions before using this pre-filled syringe.

Information about the pre-filled syringe

The pre-filled syringe (referred to as “syringe”) is disposable and for single use.

Route and method of administration

Each pack contains a pre-filled syringe of Amvuttra. Each pre-filled syringe of Amvuttra contains 25 mg of vutrisiran for subcutaneous injection, once every 3 months.

Your doctor or healthcare professional will show you and/or your caregiver how to prepare and inject a dose of Amvuttra before you do it yourself. Contact your healthcare professional or doctor for more information and help if needed.

Keep these instructions until you have used the syringe.

Storage of Amvuttra

Do not store above 30°C.

Do not freeze.

Keep this medicinal product out of the sight and reach of children.

Important warnings

Do not use the medicinal product if the pack is damaged or shows signs of handling.

Do not use the syringe if it has fallen onto a hard surface.

Do not touch the plunger rod until you are ready to administer the injection.

Do not remove the needle shield until just before the injection.

Do not reattach the needle shield to the syringe at any time.