Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - onpattro

Document Subject

Generated Narrative: MedicinalProductDefinition mpfd0c928ba69b44963057ba928ecaf5ac

identifier: http://ema.europa.eu/identifier/EU/1/18/1320/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Onpattro 2 mg/mL concentrate for solution for infusion

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-fd0c928ba69b44963057ba928ecaf5ac

identifier: http://ema.europa.eu/identifier/EU/1/18/1320/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - onpattro

Attesters

What is in this leaflet:

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

The active substance in Onpattro is patisiran.

Onpattro is a medicine that treats an illness which runs in families called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

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, abnormally shaped TTR proteins clump together to make deposits called amyloid .
• Amyloid can build up around the nerves, heart, and other places in the body, preventing them from working normally. This causes the symptoms of the illness.

Onpattro works by lowering the amount of TTR protein that the liver makes.

• This means there is less TTR protein in the blood that can form amyloid.
• This can help to reduce the effects of this illness.

Onpattro is used in adults only.

You must not be given Onpattro

• if you have ever had a severe allergic reaction to patisiran, or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or nurse before you are given Onpattro.

Warnings and precautions

Infusion-related reactions

Onpattro is given as a drip into a vein (called an intravenous infusion ). Reactions to this infusion may happen during treatment with Onpattro. Before each infusion you will be given medicines that help to lower the chance of infusion-related reactions (see Medicines given during treatment with Onpattro in section 3).

Tell your doctor or nurse straight away if you get any signs of an infusion-related reaction. These signs are listed at the beginning of section 4. If you have an infusion-related reaction, your doctor or nurse may slow down or stop your infusion, and you may need to take other medicines to control the symptoms. When these reactions stop, or get better, your doctor or nurse may decide to start the infusion again.

Vitamin A deficiency

Treatment with Onpattro lowers the amount of vitamin A in your blood. Your doctor will measure your vitamin A levels. If your vitamin A levels are low, your doctor will wait until your vitamin A levels have returned to normal and any symptoms due to vitamin A deficiency have resolved before you start treatment with Onpattro.. Symptoms of vitamin A deficiency may include:

• Decrease in night vision, dry eyes, poor vision, hazy or cloudy vision

If you have problems with your vision or any other eye problems whilst using Onpattro, you should talk to your doctor. Your doctor may refer you to an eye specialist for a check-up if it is necessary.

Your doctor will ask you to take a daily vitamin A supplement during treatment with Onpattro.

Both too high and too low levels of vitamin A can harm the development of your unborn child. Therefore, women of child-bearing age should not be pregnant when starting treatment with Onpattro and should practise effective contraception (see section Pregnancy, breast-feeding and contraception
below).

Tell your doctor if you are planning to become pregnant. Your doctor may tell you to stop taking Onpattro. Your doctor will ensure that your vitamin A levels have returned to normal before you try to become pregnant.

Tell your doctor if you have an unplanned pregnancy. Your doctor may tell you to stop taking Onpattro. During the first 3 months of your pregnancy, your doctor may tell you to stop your vitamin A supplement. During the last 6 months of your pregnancy you should resume vitamin A supplementation if the vitamin A levels in your blood have not yet returned to normal, because of an increased risk of vitamin A deficiency during the last 3 months of your pregnancy.

Children and adolescents

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

Other medicines and Onpattro

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is important to tell your doctor or nurse if you are taking any of the following medicines as your doctor may need to change the dose:

• Bupropion, a medicine used to treat depression or to help you to stop smoking
• Efavirenz, a medicine used to treat HIV infection and AIDS

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 for advice before starting this medicine.

Women of child-bearing age

Onpattro will reduce the level of vitamin A in your blood, which is important for normal development of your unborn child. If you are a woman of child-bearing age, you should practise effective contraception during treatment with Onpattro. Talk to your doctor or nurse about suitable methods of contraception. Pregnancy should be excluded before starting treatment with Onpattro.

Pregnancy

You should not use Onpattro if you are pregnant, unless advised by your doctor. If you are of child- bearing age and intend to use Onpattro, you should practise effective contraception.

Breast-feeding

Ingredients of Onpattro may pass into breast milk. Talk to your doctor about stopping breast-feeding or treatment with Onpattro.

Driving and using machines

Onpattro is believed to have no or negligible influence on the ability to drive or use machines. Your doctor will tell you whether your condition allows you to drive vehicles and use machines safely.

Onpattro contains sodium

This medicine contains 3.99 milligrams (mg) of sodium (main component of cooking/table salt) per millilitre (mL). This is 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

How much Onpattro is given

• Your doctor will work out how much Onpattro to give you this will depend on your body weight.
• The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body weight given once every 3 weeks.

How Onpattro is given

• Onpattro will be given to you by a doctor or nurse.
• It is given as a drip into a vein ( intravenous infusion ) usually over about 80 minutes.

If you do not have problems with your infusions in the clinic, your doctor may talk with you about a healthcare professional giving you your infusions at home.

Medicines given during treatment with Onpattro

About 60 minutes before each infusion of Onpattro, you will be given medicines that help to lower the risk of infusion-related reactions (see section 4). These include anti-histamines, a corticosteroid (a medicine that suppresses inflammation), and a pain reliever.

How long to use Onpattro

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

If you are given more Onpattro than you should receive

This medicine will be given to you by your doctor or nurse. In the unlikely event that you are given too much (an overdose) your doctor or nurse will check you for side effects.

If you miss your dose of Onpattro

If you miss an appointment to have Onpattro, ask your doctor or nurse when to book your next treatment.

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.

Infusion-related reactions

Infusion-related reactions are very common (may affect more than 1 in 10 people).

Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during treatment. The infusion may need to be slowed down or stopped, and you may need to take other medicines to manage the reaction.

• Stomach pain
• Feeling sick (nausea)
• Body aches or pain, including pain in the back, neck, or joints
• Headache
• Feeling tired (fatigue)
• Chills
• Dizziness
• Cough, feeling short of breath, or other breathing problems
• Reddening of the face or body (flushing), warm skin, rash or itching
• Chest discomfort or chest pain
• Rapid heart rate
• Low or high blood pressure; some patients have fainted during the infusion due to low blood pressure
• Pain, redness, burning sensation, or swelling at or near the infusion site
• Swelling of the face
• Changes in the sound or tone of your voice (hoarseness)

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

• Swelling of the arms or legs (peripheral oedema)

Common: may affect up to 1 in 10 people

• Pain in the joints (arthralgia)
• Muscle spasms
• Indigestion (dyspepsia)
• Shortness of breath (dyspnoea)
• Redness of the skin (erythema)
• Feeling dizzy or faint (vertigo)
• Stuffy or runny nose (rhinitis)
• Irritation or infection of the airways (sinusitis, bronchitis)

Uncommon: may occur in up to 1 in 100 infusions

• Leakage of the medicine into the surrounding tissue at the site of infusion, which may cause swelling or redness

Tell your doctor or nurse if you notice any of the side effects listed above.

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 after EXP . The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C). Do not freeze.

If refrigeration is not available, Onpattro can be stored at room temperature (up to 25 C) for up to 14 days.

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 Onpattro contains

• The active substance is patisiran.
• Each mL contains patisiran sodium equivalent to 2 mg patisiran.
• Each vial contains patisiran sodium equivalent to 10 mg patisiran.
• The other ingredients are DLin-MC3-DMA ((6Z,9Z,28Z,31Z)-heptatriaconta-6,9,28,31-tetraen-19-yl-4- (dimethylamino) butanoate), PEG2000-C-DMG ( - (3 -{[1,2-di(myristyloxy)propanoxy]carbonylamino}propyl)- -methoxy, polyoxyethylene), DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), cholesterol, disodium hydrogen phosphate, heptahydrate, potassium dihydrogen phosphate, anhydrous, sodium chloride, and water for injections (see Onpattro contains sodium in section 2).

What Onpattro looks like and contents of the pack

• Onpattro is a white to off-white, opalescent, homogeneous concentrate for solution for infusion (sterile concentrate).
• Onpattro is supplied in cartons containing one vial each.

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

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

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

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

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

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

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

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

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

Polska Alnylam Netherlands B.V. Tel: 0800 000 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

Slovensk republika Alnylam Netherlands B.V. Tel: 0800 601 medinfo@alnylam.com

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

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

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

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

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

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

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

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

This leaflet was last revised in MM/YYYY.

Other sources of information

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