Amvuttra 25 mg solution for injection in pre-filled syringe: detailed information

Brand name Amvuttra 25 mg solution for injection in pre-filled syringe

Form solution for injection in a pre-filled syringe

Active substance / Dosage

VUTRISIRAN · 25 mg

Prescription type Hospital Use Only

ATC code

N07X N07XX N07XX18

Registration number 1221681001

Manufacturer Alnylam Netherlands B.V.

Amvuttra 25 mg solution for injection in pre-filled syringe solution for injection in a pre-filled syringe

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Amvuttra is and what it is used for
2. What you need to know before using Amvuttra
3. How to use Amvuttra
4. Possible adverse effects
5. Storage of Amvuttra
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amvuttra 25mg solution for injection in pre-filled syringe

vutrisiran

This medicine is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

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, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Amvuttra is and what it is used for

The active substance in Amvuttra is vutrisiran.

What Amvuttra is used for

Amvuttra is used to treat a disease called "ATTR amyloidosis". This disease may be hereditary or may be due to aging. ATTR amyloidosis is caused by problems with a protein in the body called "transthyretin" (TTR). This protein is mainly produced in the liver and transports vitamin A and other substances throughout the body.

In people with this disease, small fibers of the TTR protein clump together to form deposits called "amyloid". Amyloid can accumulate around nerves, the heart, and other parts of the body, or within these organs, interfering with their normal function. This causes the symptoms of the disease.

How Amvuttra works

Amvuttra works by reducing the amount of TTR protein produced by the liver, resulting in lower levels of TTR protein in the blood available to 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

Do not use Amvuttra

if you have ever had a serious allergic reaction to vutrisiran or to any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Reduced levels of vitamin A in the blood and vitamin supplementation

Amvuttra reduces the amount of vitamin A in the blood.

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

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

If you notice any changes in your vision or any other eye problems while using Amvuttra, consult your doctor. Your doctor may refer you to an ophthalmologist for an evaluation.

Both excessively high and low levels of vitamin A can harm fetal development. Therefore, pregnancy must be ruled out in women of childbearing potential before starting treatment with Amvuttra, and effective contraceptive methods must be used (see 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 instruct you to stop using Amvuttra 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 in case of an unplanned pregnancy. Your doctor will instruct you to stop using 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 blood 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

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

Other medicines and Amvuttra

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

Pregnancy, breastfeeding and contraception

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

Pregnancy

Do not use Amvuttra if you are pregnant.

Women of childbearing potential

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

If you are a woman who can become pregnant, you must use an effective method of contraception during treatment with Amvuttra.
Consult your doctor or nurse about suitable contraceptive methods.
Pregnancy must be excluded before starting treatment with Amvuttra.
Inform your doctor if you plan to become pregnant or if you have an unplanned pregnancy. Your doctor will instruct you to stop taking Amvuttra.

Breastfeeding

It is unknown whether vutrisiran passes into breast milk. Your doctor will weigh the potential benefits of treatment for you against the possible risks to the breastfed infant.

Driving and using machines

Amvuttra is considered to have no or negligible influence on the ability to drive or use machines. Your doctor will advise you whether your condition allows you to drive or operate machinery safely.

Amvuttra contains sodium

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

3. How to use Amvuttra

Amvuttra may be self-administered or administered by a caregiver or 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 leaflet.

How much Amvuttra to use

The recommended dose is 25 mg once every 3 months.

Where the injection is given

Amvuttra is administered by subcutaneous injection (injection under the skin) in the stomach area (abdomen), upper arm (if someone else is administering the injection), or 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.

If you use 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 whether you have any adverse effects.

If you forget to use Amvuttra

If you miss a dose, administer Amvuttra as soon as possible. From then on, resume dosing every 3 months, counting from the most recently administered 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 can cause adverse effects, although not everyone will experience them.

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

Frequent: may affect up to 1 in 10 people

Redness, pain, itching, bruising, or warmth at the injection site
Blood tests showing increased liver enzymes called alkaline phosphatase and alanine transaminase

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amvuttra

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

Do not use this medicine after the expiry date stated on the label, on the tray lid, and on the carton after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amvuttra

The active substance is vutrisiran.

Each pre-filled syringe contains sodium vutrisiran 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 injections. Sodium hydroxide and phosphoric acid may be used to adjust the pH (see "Amvuttra contains sodium" in section 2).

Appearance of the medicine and contents of the pack

This medicine is a clear, colourless to yellow, injectable solution (injection). Each pack contains one single-use pre-filled syringe.

Marketing Authorisation Holder and Manufacturer

Alnylam Netherlands B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

The Netherlands

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

Belgium/Belgium/Belgium

Alnylam Netherlands B.V.

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

Step 1: Gather the materials Gather and place the following materials (not supplied) on a clean, flat surface: Alcohol wipe Gauze or cotton ball Bandage Sharps container
Step 2: Prepare the syringe If stored in the refrigerator, allow the syringe to reach room temperature for 30 minutes 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 its packaging by holding it by the barrel. Do not touch the plunger rod until you are ready to administer the injection. Do not use the syringe if it has been dropped on a hard surface. Do not remove the needle cap just before injection.
Step 3: Inspect the syringe Check: That the syringe is not damaged, cracked, or leaking. That the needle cap is intact and attached to the syringe. That the drug solution in the syringe is clear and colorless to yellow. That “Amvuttra 25 mg” appears on the syringe label. The expiration date on the syringe label. It is normal to see air bubbles inside the syringe. Do not use the syringe if any problems are observed when inspecting the syringe or drug solution. Do not use if past the expiration date. Do not use if the drug solution contains particles, is cloudy, or has changed color. Contact your healthcare professional if you notice any problems.
Step 4: Choose the injection site Choose an injection site from the following areas: Abdomen, except within 5 cm around the navel. Front of the thighs. If someone else is administering the injection, the upper back of the arms may also be used. Do not inject into areas of skin that are tender, red, swollen, bruised, or hard, or within 5 cm of the navel.
Step 5: Prepare for injection Wash your hands with soap and water and dry them thoroughly with a clean towel.
Clean the chosen injection site with an alcohol wipe. Allow the skin to air dry before injecting. Avoid touching or blowing on the injection site after cleaning.
Step 6: Remove the needle cap Hold the syringe barrel with one hand. Remove the needle cap by pulling it straight off with the other hand and discard 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 contact any surface. Do not re-cap the syringe. Do not pull the plunger rod. Do not use the syringe if it has been dropped on a hard surface.
Step 7: Insert the needle With your free hand, gently pinch the clean skin around the injection site to create a small raised area for injection.
Insert the needle fully into the pinched skin at a 45–90° angle.
Step 8: Inject the medication Using the push disk, press the plunger rod while holding the syringe by the wings.
Push the plunger rod all the way down to inject the full dose of medication. You must press the plunger rod all the way down to deliver the full dose.
Step 9: Release the plunger rod Release the plunger rod to allow the needle shield to cover the needle. Remove the syringe from the skin. Do not block the movement of the plunger rod. Do not pull down on the needle shield. The needle shield automatically covers the needle.
Step 10: Check the injection site There may be a small amount of blood or fluid at the injection site. If so, press a gauze or cotton ball over the site until bleeding stops. Avoid rubbing the injection site.
Step 11: Dispose of the syringe Immediately dispose of the used syringe in a sharps container. Use only a sharps container for syringe disposal.