Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - givlaari

Document Subject

Generated Narrative: MedicinalProductDefinition mp5e3f046139a16b84f12a9b50f2d2b2ef

identifier: http://ema.europa.eu/identifier/EU/1/20/1428/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Givlaari 189 mg/mL solution for injection.

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-5e3f046139a16b84f12a9b50f2d2b2ef

identifier: http://ema.europa.eu/identifier/EU/1/20/1428/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - givlaari

Attesters

What is in this leaflet

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

What Givlaari is

Givlaari contains the active substance givosiran .

What Givlaari is used for

Givlaari is used to treat acute hepatic porphyria in adults and adolescents aged 12 years and older.

What acute hepatic porphyria is

Acute hepatic porphyria is a rare illness that runs in families. It is caused by a defect in one of the proteins that make a molecule called haem in the liver. Because there is a problem in one of the proteins required to make haem, there is a build-up of some of the substances that are used to produce haem, namely aminolevulinic acid (ALA) and porphobilinogen (PBG). Having too much ALA and PBG can injure nerves and cause serious attacks of pain, nausea, muscle weakness and changes in mental functioning. Some people with acute hepatic porphyria may also have symptoms, such as pain and nausea, in between attacks. Longer-term complications that can be seen in people with acute hepatic porphyria include high blood pressure, chronic kidney disease and liver disease.

How Givlaari works

This medicine works by lowering the amount of an enzyme, called ALAS1, that controls how much ALA and PBG are made by the liver. By lowering ALAS1, the liver makes less ALA and PBG. This can help to reduce the effects of this illness.

You must not be given Givlaari

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

Warnings and precautions

Talk to your doctor or nurse before you are given this medicine.

Severe allergic reaction

• Tell your doctor or nurse straight away if you get any signs of a severe allergic reaction. The signs are listed in Serious side effects in section 4. * If you have a severe allergic reaction, your doctor or nurse will stop using the medicine straight away and you may need to take other medicines to control the symptoms.

Liver problems

Using this medicine can affect your liver. You will have blood tests to check your liver function before you start treatment with Givlaari and periodically during treatment. If these tests show abnormal results, your doctor or nurse will decide whether to interrupt treatment or stop treatment permanently. Abnormal results have been seen in some patients treated with this medicine, mainly between 3 to 5 months after starting treatment.

Kidney problems

Using this medicine can affect your kidneys, especially if you have already been diagnosed with kidney problems. Your doctor will check how your kidneys are working while you are using this medicine, especially if you already have kidney problems.

Tests for homocysteine levels

While receiving this medicine, blood tests may show an increase in homocysteine, a type of amino acid, compared to your homocysteine levels before starting treatment. Your doctor will check the levels of homocysteine in your blood before and during treatment. If your homocysteine levels are elevated, your doctor may give you homocysteine-lowering therapy.

Children

This medicine should not be used in children below 12 years of age because there is no experience of using the medicine in this age group.

Other medicines and Givlaari

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

When using certain medicines, this medicine may prolong or increase their effect or change their side effects.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Breast-feeding

Studies in animals suggest this medicine may pass into breast milk. If you are breast-feeding ask your doctor for advice before taking this medicine. Your doctor will then help you decide whether to stop breast-feeding or to stop treatment with Givlaari taking into account the benefit of breast-feeding for your child and benefit of therapy for you.

Driving and using machines

This medicine is unlikely to have any effect on your ability to drive or use machines.

Givlaari contains sodium

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

How much Givlaari is given

Your doctor will work out how much medicine to give you. The amount will depend on your body weight.

• The recommended dose is 2.5 milligrams for every kilogram you weigh
• You will be given the medicine once a month (every 4 weeks)
• If blood tests show problems with your liver, your doctor may interrupt Givlaari treatment or stop treatment permanently. Your doctor may consider starting again at a lower dose.

How Givlaari is given

This medicine will be given to you once every month by a doctor or nurse. It is given as an injection under the skin (subcutaneously) into your stomach area (abdomen), or in some cases, your upper arm or thigh. The site of the injection will be rotated. If the dose is more than 1 mL, more than one vial will need to be used and more than one subcutaneous injection may need to be given.

If you are given too much Givlaari

In the unlikely event that your doctor or nurse gives you too much (an overdose) they will check you for side effects.

If you miss your dose of Givlaari

If you have missed an appointment for your injection, talk to your doctor or nurse as soon as possible. If you have any further questions on the use of this medicine, ask your doctor or nurse.

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

Serious side effects

Severe allergic reactions (uncommon: may affect up to 1 in 100 people)

Tell your doctor or nurse straight away if you get any of the following signs of a severe allergic reaction (anaphylactic reaction) the injection will need to be stopped and you may need to take other medicines to manage the reaction:

• swelling mainly of the lips, tongue or throat which makes it difficult to swallow or breathe
• breathing problems or wheezing
• feeling dizzy or fainting
• rash, hives
• itching

Other side effects

Tell your doctor or nurse if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• Nausea
• Redness, pain, itching or swelling at the site of the injection (injection site reaction)
• Skin rashes including red, itchy, or dry skin, eczema, or hives
• Feeling tired
• Blood tests showing an increase in transaminases, which are liver enzymes (a sign of possible liver inflammation)
• Blood tests showing an increase in creatinine, a substance removed from your body by your kidneys, or decrease in glomerular filtration rate (signs of possible kidney problems)

Common: may affect up to 1 in 10 people

• A type of allergic reaction (hypersensitivity) with symptoms such as hives, rash, swelling of eyes, mouth or face, difficulty breathing, itching.
• Inflammation of the pancreas (pancreatitis).
• Blood test showing an increase in homocysteine (a type of amino acid)

Reporting of side effects

If you get any side effects, talk to your doctor 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 carton and vial after EXP. The expiry date refers to the last day of that month.

This medicine is for single use only. Once the product is opened, use immediately.

Do not store above 25 C.

Keep vial in the outer carton to protect from light.

Do not throw away any medicines via wastewater or household waste. Your doctor or nurse will throw away any medicines that are no longer being used. These measures will help protect the environment.

What Givlaari contains

• The active substance is givosiran.
• Each mL contains givosiran sodium equivalent to 189 mg givosiran.
• The other ingredients are sodium hydroxide, phosphoric acid and water for injections.

What Givlaari looks like and contents of the pack

This medicine is a clear, colourless to yellow solution for injection.

Each pack contains one vial of 1 mL solution for injection.

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: