Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - amvuttra

Document Subject

Generated Narrative: MedicinalProductDefinition mp390f2bf9e603dd85f443eae025f147b6

identifier: http://ema.europa.eu/identifier/EU/1/22/1681/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-390f2bf9e603dd85f443eae025f147b6

identifier: http://ema.europa.eu/identifier/EU/1/22/1681/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - amvuttra

Attesters

What is in this leaflet

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

The active substance in Amvuttra is vutrisiran.

What Amvuttra is used for

Amvuttra is used for the treatment of an illness called hereditary ATTR or hATTR amyloidosis . This is an illness which runs in families. hATTR amyloidosis is caused by problems with a protein in the body called transthyretin (TTR). This protein 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 causes the symptoms of the illness.

How Amvuttra works

Amvuttra works by lowering the amount of TTR protein made by the liver which means there is less TTR protein in the blood that can form amyloid. This can help to reduce the effects of this illness.

Amvuttra is used in adults only.

You must not be given Amvuttra

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

If you are not sure, talk to your doctor, pharmacist or nurse before you are given this medicine.

Warnings and precautions

Lowered vitamin A levels in the blood and vitamin supplements

Amvuttra lowers the amount of vitamin A in your blood. Your doctor will ask you to take a daily vitamin A supplement. Please follow the vitamin A dose recommended by your doctor. Signs of low vitamin A may include: sight problems especially at night, dry eyes, hazy, or cloudy vision.

• If you notice a change in your vision or any other eye problems whilst using Amvuttra, talk to your doctor. Your doctor may send you to an eye specialist for a check-up.

Both too high and too low levels of vitamin A can harm the development of your unborn child. Therefore, women of childbearing age should exclude any pregnancy before starting treatment with Amvuttra and practise effective contraception (see section Pregnancy, breast-feeding and contraception below).

• Vitamin A levels may remain low for more than 12 months after the last dose of Amvuttra.
• Tell your doctor if you are planning to become pregnant. Your doctor will tell you to stop taking Amvuttra and vitamin A supplementation. Your doctor will also ensure that your vitamin A levels have returned to normal before conception is attempted.
• Tell your doctor if you have an unplanned pregnancy. Your doctor will tell you to stop taking Amvuttra. 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, you 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

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

Other medicines and Amvuttra

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

Pregnancy, breast-feeding and contraception

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before starting this medicine.

Pregnancy

You should not use Amvuttra if you are pregnant.

Women of childbearing age

Amvuttra 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 above).

• You should use effective contraception during treatment with Amvuttra - if you are a woman who is able to become pregnant.
• Talk to your doctor or nurse about suitable methods of contraception.
• Pregnancy should be excluded before starting treatment with Amvuttra.
• Tell your doctor if you are planning to become pregnant or if you have an unplanned pregnancy. Your doctor will tell you to stop taking Amvuttra.

Breast-feeding

It is not known if vutrisiran passes into breast milk. Your doctor will consider the potential benefits of treatment for you - compared with the risks of breast-feeding for your baby.

Driving and using machines

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

Amvuttra contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially sodium- free .

This medicine will be given to you by a doctor, pharmacist, or nurse.

How much Amvuttra you are given

The recommended dose is 25 mg once every 3 months.

Where the injection is given

Amvuttra is given by injection under the skin ( subcutaneous injection ) into your stomach area (abdomen), upper arm or thigh.

How long to use Amvuttra

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

If you receive more Amvuttra than you should

In the unlikely event that you are given too much (an overdose), your doctor will check you for side effects.

If you miss your dose of Amvuttra

If you miss an appointment for your Amvuttra injection, contact your doctor, pharmacist or nurse as soon as you can to arrange to have the injection you missed.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very common: may affect more than 1 in 10 people

• Pain in the joints
• Pain in arms and legs

Common: may affect up to 1 in 10 people

• Being short of breath
• Redness, pain, itching, bruising, or warmth where the injection was given
• Blood tests showing increases in a liver enzyme called alkaline phosphatase

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

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

Do not store above 30 C. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

What Amvuttra contains

• The active substance is vutrisiran. Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg vutrisiran in 0.5 mL solution.
• The other ingredients 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).

What Amvuttra looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Alnylam Netherlands B.V. Antonio Vivaldistraat 1083 HP Amsterdam Netherlands

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

Belgi /Belgique/Belgien Alnylam Netherlands B.V. T l/Tel: 0800 81 443 (+32 234 208 71) medinfo@alnylam.com

Luxembourg/Luxemburg Alnylam Netherlands B.V. T l/Tel: 80085235 (+352 203 014 48) medinfo@alnylam.com

Genesis Pharma Bulgaria EOOD Te .: +359 2 969 3medinfo@genesispharmagroup.com

Malta Genesis Pharma (Cyprus) Ltd Tel: +357 22765medinfo@genesispharmagroup.com

esk republika Alnylam Czech s.r.o. Tel: 800 050 450 (+420 234 092 195) medinfo@alnylam.com

Nederland Alnylam Netherlands B.V. Tel: 08002820025 (+31 203697861) medinfo@alnylam.com

Danmark Alnylam Sweden AB Tlf: 433 105 15 (+45 787 453 01) medinfo@alnylam.com

Norge Alnylam Sweden AB Tlf: 800 544 00 (+472 1405 657) medinfo@alnylam.com

Deutschland Alnylam Germany GmbH Tel: 08002569526 (+49 8920190112) medinfo@alnylam.com

sterreich Alnylam Austria GmbH Tel: 0800070339 (+43 720 778 072) medinfo@alnylam.com

 .   

: +30 210 87 71 medinfo@genesispharmagroup.com

Portugal Alnylam Portugal Tel: 707201512 (+351 707502642) medinfo@alnylam.com

Espa a Alnylam Pharmaceuticals Spain SL Tel: 900810212 (+34 910603753) medinfo@alnylam.com

Rom nia Genesis Biopharma Romania SRL Tel: +40 21 403 4medinfo@genesispharmagroup.com

France Alnylam France SAS T l: 0805542656 (+33 187650921) medinfo@alnylam.com

Slovenija Genesis Pharma Adriatic d.o.o Tel: +385 1 5813 medinfo@genesispharmagroup.com

Hrvatska Genesis Pharma Adriatic d.o.o Tel: +385 1 5813 medinfo@genesispharmagroup.com

Suomi/Finland Alnylam Sweden AB Puh/Tel: 0800 417 452 (+358 942 727 020) medinfo@alnylam.com

Ireland Alnylam Netherlands B.V. Tel: 1800 924260 (+353 818 882213) medinfo@alnylam.com

Sverige Alnylam Sweden AB Tel: 020109162 (+46 842002641) medinfo@alnylam.com

Italia Alnylam Italy S.r.l. Tel: 800 90 25 37 (+39 02 89 73 22 91) medinfo@alnylam.com

United Kingdom (Northern Ireland) Alnylam UK Ltd. Tel: 08001412569 (+44 1628 878592) medinfo@alnylam.com

Genesis Pharma (Cyprus) Ltd : +357 22765medinfo@genesispharmagroup.com

Eesti, sland, Latvija, Lietuva, Magyarorsz g, Polska, Slovensk republika Alnylam Netherlands B.V. Tel/S mi: +31 20 369 7medinfo@alnylam.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: