Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nexviadyme

Document Subject

Generated Narrative: MedicinalProductDefinition mpaf5a6458bf787a6cbcce31dd9f99f24f

identifier: http://ema.europa.eu/identifier/EU/1/21/1579/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Nexviadyme 100 mg powder for concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-af5a6458bf787a6cbcce31dd9f99f24f

identifier: http://ema.europa.eu/identifier/EU/1/21/1579/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - nexviadyme

Attesters

What is in this leaflet

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

What Nexviadyme is Nexviadyme contains an enzyme called avalglucosidase alfa it is a copy of the natural enzyme called acid alpha-glucosidase (GAA) that is lacking in people with Pompe disease.

What Nexviadyme is used for Nexviadyme is used to treat people of all ages who have Pompe disease.

People with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA). This enzyme helps control levels of glycogen (a type of carbohydrate) in the body. Glycogen provides the body with energy, but in Pompe disease high levels of glycogen build up in different muscles and damages them. The medicine replaces the missing enzyme so that the body can reduce the build-up of glycogen.

Do not use Nexviadyme
If you have had life-threatening allergic (hypersensitive) reactions to avalglucosidase alfa or any of the other ingredients of this medicine (listed in section 6) and these reactions occurred again after stopping and restarting the medicine.

Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Nexviadyme

Speak to your doctor immediately if treatment with Nexviadyme causes:

• allergic reactions, including anaphylaxis (a severe allergic reaction) see under Possible side effects , below for symptoms
• infusion-associated reaction while you are receiving the medicine or in the few hours afterwards see under Possible side effects , below for symptoms

Also tell your doctor if you have swelling in your legs or widespread swelling of your body. Your doctor will decide if your Nexviadyme infusion should stop and the doctor will give you appropriate medical treatment. Your doctor will also decide if you can continue receiving avalglucosidase alfa.

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

Pregnancy and breast-feeding and fertility
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 using this medicine. There is no information about the use of Nexviadyme in pregnant women. You must not receive Nexviadyme during pregnancy unless your doctor specifically recommends it. You and your doctor should decide if you can use Nexviadyme if you are breast-feeding.

Driving and using machines
Nexviadyme may have a minor effect on the ability to drive and use machines. Because dizziness, low blood pressure and sleepiness can occur as infusion-associated reactions, this may affect the ability to drive and use machines on the day of the infusion.

Nexviadyme will be given to you under the supervision of a health care professional who is experienced in the treatment of Pompe disease.

You may be given other medicines before you receive Nexviadyme, to reduce some side effects. Such medicines include an antihistamine, a steroid and a medicine (such as paracetamol) to reduce fever.

The dose of Nexviadyme is based on your weight and will be given to you once every 2 weeks.

• The recommended dose of Nexviadyme is 20 mg/kg of body weight.

Home infusion Your doctor may consider that you can have home infusion of Nexviadyme if it is safe and convenient to do so. If you get any side effects during an infusion of Nexviadyme, your home infusion staff member may stop the infusion and start appropriate medical treatment.

Instructions for proper use
Nexviadyme is given through a drip into a vein (intravenous infusion). It is supplied to the healthcare professional as a powder to mix with sterile water and further dilute with glucose before infusing it.

If you are given more Nexviadyme than you should
Excessive infusion rate of Nexviadyme may result in hot flush.

If you miss your dose of Nexviadyme
If you have missed an infusion, please contact your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

If you stop using Nexviadyme
Speak to your doctor if you wish to stop Nexviadyme treatment. The symptoms of your disease may worsen if you stop treatment.

Side effects mainly occur while patients are being given Nexviadyme infusion or shortly afterwards. You must tell your doctor immediately if you get an infusion-associated reaction or an allergic reaction. Your doctor may give you medicines before your infusion to prevent these reactions.

Infusion-associated reactions Mostly infusion-associated reactions are mild or moderate. Symptoms of infusion-associated reaction include chest discomfort, increased blood pressure, increased heart rate, chills, cough, diarrhoea, fatigue, headache, flu-like illness, nausea, vomiting, red eye, pain in arms and legs, skin redness, itchy skin, rash, and hives.

Allergic reactions Allergic reactions may include symptoms such as difficulty breathing, chest pressure, flushing, cough, dizziness, nausea, redness on palms and feet, itchy palms and feet, swollen lower lip and tongue, low level of oxygen in the blood, and rash.

Common (may affect up to 1 in 10 people)

• Anaphylaxis (severe allergic reaction)
• Tremor (shaking)
• Red eyes
• Raised blood pressure
• Headache
• Dizziness
• Cough
• Difficulty breathing
• Nausea
• Diarrhoea
• Vomiting
• Lip swelling
• Swollen tongue
• Itchy skin
• Hives
• Rash
• Redness of hands
• Redness of skin
• Muscle spasms
• Muscle aches
• Fatigue
• Chills
• Chest discomfort
• Pain
• Flu-like illness
• Low blood oxygen

Uncommon (may affect up to 1 in 100 people)

• Inflammation of eyes
• Numbness or tingling
• Itchy eyes
• Watery eyes
• Rapid heart beat
• Extra heart beats
• Flushing
• Low blood pressure
• Rapid breathing
• Swelling of throat
• Throat irritation
• Abdominal (belly) pain
• Swelling of skin
• Sweating
• Facial pain
• Increased body temperature
• Infusion site tissue leakage
• Infusion site joint pain
• Infusion site rash
• Infusion site itching
• Localised oedema
• Swelling in the arms and legs
• Fever
• Breath sounds abnormal (wheezing)
• Feeling tired
• Pain in arm or leg
• Pale skin
• Blood test for inflammation
• Weakness
• Indigestion
• Reduced sensation to touch, pain, and temperature
• Numbness in the mouth, tongue, or lip
• Tingling in the mouth, tongue, or lip
• Difficulty swallowing
• Flank pain
• Feeling cold
• Oral discomfort (including lip burning sensation)
• Burning sensation
• Abdominal pain upper

The reported side effects seen in children and adolescents were similar to those seen in adults.

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

Unopened vials:
Store in a refrigerator (2 C - 8 C).

Reconstituted solution: After reconstitution, immediate use for dilution is recommended. The reconstituted solution can be stored up to 24 hours when refrigerated at 2 C to 8 C.

Diluted solution: After dilution, immediate use is recommended. The diluted solution can be stored for 24 hours at 2 C to 8 C followed by 9 hours at room temperature (up to 25 C).

Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

What Nexviadyme contains
The active substance is avalglucosidase alfa. One vial contains 100 mg of avalglucosidase alfa. After reconstitution, the solution contains 10 mg of avalglucosidase alfa per ml and after dilution the concentration varies from 0.5 mg/ml to 4 mg/ml. The other ingredients are

• Histidine
• Histidine hydrochloride monohydrate
• Glycine
• Mannitol
• Polysorbate What Nexviadyme looks like and contents of the pack Avalglucosidase alfa is a powder for concentrate for solution for infusion in a vial (100 mg/vial). Each pack contains 1, 5, 10, or 25 vials. Not all pack sizes may be marketed.

The powder is white to pale yellow. After reconstitution it is a clear, colourless to pale yellow solution. The reconstituted solution must be further diluted.

Marketing Authorisation Holder Sanofi B.V. Paasheuvelweg 1105 BP Amsterdam The Netherlands

Manufacturer Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

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

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: + 32 2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium T l/Tel: + 32 2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71
Sanofi-Aventis AEBE
: +30 210 900 1 sterreich sanofi-aventis GmbH Tel: + 43 1 80 185 0 Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger: +33 1 57 63 23 Portugal Sanofi Produtos Farmac uticos, Lda. Tel: +21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800536Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA
Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel +44 (0) 800 035 2This leaflet was last revised in

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