Introduction

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

1. What is Amvuttra and what is it used for

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.

2. What you need to know before using Amvuttra

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”.

3. How to Use Amvuttra

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.

4. Possible Adverse Effects

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.

5. Amvuttra Storage

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.

6. Contents of the packaging and additional information

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:

België/Belgique/Belgien

Alnylam Netherlands B.V.

Tel/Tel: 0800 81 443 (+32 234 208 71)

Step1: Gather materials Gather and place the following materials (not supplied) on a flat and clean surface: Alcohol wipe Swabs or cotton Appliqué Sharps container
Step2: Prepare the syringe If stored in the refrigerator, leave the syringe at room temperature for 30 minutes to allow it to come to room temperature before use. Do not heat the syringe in any other way, e.g. microwave, hot water or near other heat sources. Remove the syringe from the pack by holding the barrel. Do not touch the plunger rod until you are ready to administer the injection. Do not use the syringe if it has fallen onto a hard surface. Do not remove the needle shield until just before the injection.
Step3: Inspect the syringe Check: That the syringe is not damaged, e.g. cracked or leaking. That the needle shield is intact and securely attached to the syringe. That the solution of the medicinal product in the syringe is transparent and colourless to yellowish. That “Amvuttra 25 mg” appears on the label of the syringe. The expiry date on the label of the syringe. It is normal to see air bubbles inside the syringe. Do not use the syringe if any problems are detected when checking the syringe and the solution of the medicinal product. Do not use the syringe if it has expired. Do not use the syringe if the solution of the medicinal product contains particles or is cloudy or has changed colour. Contact your healthcare professional if you detect any problems.
Step4: Choose the injection site Choose an injection site from the following areas: Abdomen, except for the 5 cm around the navel. Front of the thighs. If someone else is administering the injection, it can also be injected in the upper back of the upper arms. Do not inject in areas of skin that are sensitive, red, swollen, bruised or hard or less than 5 cm from the navel.
Step5: Prepare for the injection Wash your hands with soap and water and dry them well with a clean towel.
Clean the chosen injection site with an alcohol wipe. Allow the skin to dry at room temperature before the injection. Avoid touching or blowing on the injection site after cleaning it.
Step6: Remove the needle shield Hold the barrel of the syringe with one hand. Remove the needle shield from the needle by pulling it directly off with the other hand and dispose of it immediately. It is normal to see a drop of liquid at the tip of the needle. Do not touch the needle or let it touch any surface. Do not reattach the needle shield to the syringe. Do not pull the plunger rod. Do not use the syringe if it has fallen onto a hard surface.
Step7: Insert the needle With the other hand, gently pinch the clean skin around the injection site to create a small bulge for the injection.
Insert the needle completely into the pinched skin at an angle of 45-90°.
Step8: Inject the medicinal product Using the push button, press the plunger rod while holding the syringe by the wings.
Press the plunger rod all the way down to inject all of the medicinal product solution. You must press the plunger rod all the way down to administer the dose.
Step9: Release the plunger rod Release the plunger rod to cover the needle. Remove the syringe from the skin. Do not block the movement of the plunger rod. Do not pull down the needle shield. The needle shield automatically covers the needle.
Step10: Check the injection site You may see a small amount of blood or liquid at the injection site. If so, press on the injection site with a swab or cotton until it stops bleeding. Avoid rubbing the injection site.
Step11: Dispose of the syringe Dispose of the used syringe immediately in a sharps container. Use only a sharps container to dispose of syringes.

Amvuttra 25 mg solucion inyectable en jeringa precargada

Introduction

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 Adverse Effects

5. Amvuttra Storage

6. Contents of the packaging and additional information

Поговоріть з лікарем онлайн

Анна Морет

Аліна Цуркан

Андрій Попов

Євген Яковенко

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