Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - elfabrio

Document Subject

Generated Narrative: MedicinalProductDefinition mp84263cabba69906218047f0258521479

identifier: http://ema.europa.eu/identifier/EU/1/23/1724/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Elfabrio 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-84263cabba69906218047f0258521479

identifier: http://ema.europa.eu/identifier/EU/1/23/1724/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - elfabrio

Attesters

What is in this leaflet

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

Elfabrio contains the active substance pegunigalsidase alfa, and is used as enzyme replacement therapy in adult patients with confirmed Fabry disease. Fabry disease is a rare genetic disease that can affect many parts of the body. In patients with Fabry disease, a fat substance is not removed from the cells of their body, and builds up in the walls of blood vessels which can cause organ failure. This fat builds up in the cells of these patients because they do not have enough of an enzyme called - galactosidase-A, the enzyme responsible for breaking it down Elfabrio is used long-term to supplement or replace this enzyme in adult patients who have confirmed Fabry disease.

Do not use Elfabrio

• if you are severely allergic to pegunigalsidase alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before Elfabrio is used.

If you are treated with Elfabrio, you may experience a side effect during or immediately following the drip (infusion) used to give the medicine (see section 4). This is known as an infusion-related reaction and can sometimes be severe.

• Infusion-related reactions include dizziness, headache, nausea, low blood pressure, tiredness and fever. If you experience an infusion-related reaction, you must tell your doctor immediately.
• If you have an infusion-related reaction you may be given additional medicines to treat or help prevent future reactions. These medicines may include medicines used to treat allergies (antihistamines), medicines used to treat fever (antipyretics) and medicines to control inflammation (corticosteroids).
• If the infusion-related reaction is severe, your doctor will stop the infusion immediately and start giving you appropriate medical treatment or slow down treatment rate.
• If the infusion-related reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies that might affect the outcome of your treatment.
• Most of the time you can still be given Elfabrio even if you experience an infusion-related reaction.

In very rare cases, your immune system may not be able to recognise Elfabrio, leading to an immunological kidney disease (glomerulonephritis membranoproliferative). During the clinical studies, only one case occurred, and the only symptoms reported were a temporary decline of renal functions with excess proteins in the urine. The symptoms resolved upon discontinuation of the treatment.

Children and adolescents This medicine should not be used in children and adolescents. The safety and efficacy of Elfabrio in children and adolescents aged 0-17 years have not been established.

Other medicines and Elfabrio Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding You should not use Elfabrio if you are pregnant, since there is no experience with Elfabrio in pregnant women. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

It is unknown whether Elfabrio is excreted in human milk. Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding or stop taking Elfabrio, considering the benefit of breast-feeding for your baby and the benefit of Elfabrio for you.

Driving and using machines Elfabrio may cause dizziness or vertigo. If you feel dizzy or vertigo on the day of treatment with Elfabrio, do not to drive or use machines until you feel better.

Elfabrio contains sodium This medicine contains 48 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

This medicine is only to be used under the supervision of a doctor experienced in the treatment of Fabry disease or other similar diseases and should only be given by a healthcare professional.

The recommended dose is 1 mg/kg of body weight given once every two weeks.

Your doctor may advice that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home.

See information for healthcare professionals at the end of this package leaflet.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects occur during the infusion or shortly after ( infusion-related reaction , see section 2 Warnings and precautions ).

While under treatment with Elfabrio, you may experience some of the following reactions:

Serious side effects

Common side effects (may affect up to 1 in 10 people)

• hypersensitivity and serious allergic reaction (symptoms including excessive and prolonged contraction of the airway muscles causing breathing difficulty (bronchospasm), swelling of the face, mouth and throat, wheezing, low blood pressure, hives, difficulty swallowing, rash, shortness of breath, flushing, chest discomfort, itchiness, sneezing and nasal congestion)

If these side effects happen, immediately seek medical attention and stop the infusion. Your doctor will give you medical treatment if required.

Other side effects include

Common (may affect up to 1 in 10 people)

• infusion related reactions
• weakness
• feeling sick (nausea)
• rash
• abdominal pain
• dizziness
• pain
• chest pain
• headache
• muscle and joint pain
• sensations like numbness, tingling, or pins and needles (paraesthesia)
• itching (pruritus)
• diarrhoea
• vomiting
• chills
• redding of the skin (erythema)
• a spinning sensation (vertigo), arousal, irritability or confusion
• alteration of the normal heart rhythm
• agitation

Uncommon (may affect up to 1 in 100 people)

• shaking (tremor)
• high blood pressure (hypertension)
• bronchospasm (contraction of the bronchial muscles causing obstruction of breathing airways) and difficult breathing
• throat irritation
• increased body temperature
• difficulty sleeping (insomnia)
• restless legs syndrome
• nerve damage in arms and legs causing pain or numbness, burning and tingling (peripheral neuropathy)
• nerve pain (neuralgia)
• burning sensation
• flushing
• disease where stomach acid goes upwards into the oesophagus (gastro-oesophageal reflux disease)
• inflammation of the stomach lining (dyspepsia)
• indigestion
• gas (flatulence)
• diminished sweating (hypohydrosis)
• immunological kidney disease causing excess protein in the urine and renal malfunctioning (glomerulonephritis membranoproliferative)
• chronic kidney disease
• excess protein in the urine (proteinuria)
• tissue damage because the medicine that is normally infused into a vein leaks or is accidentally infused into the surrounding tissue (infusion site extravasation)
• swelling of lower legs or hands (oedema)
• swelling of arms or legs
• influenza-like illness
• nasal congestion and sneezing
• infusion site pain
• increased liver enzymes and uric acid in the blood, increased urine protein/creatinine ratio, white blood cells in the urine, as tested in the laboratory
• weight increase
• low blood pressure (hypotension)
• slow heart rate (bradycardia)
• thickening of the wall within the ventricle in the heart

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

Store in a refrigerator (2 C-8 C).

After dilution, the diluted solution should be used immediately. If not used immediately, the diluted solution should be stored for no longer than 24 hours in a refrigerator (2 C-8 C) or for no longer than 8 hours at room temperature (below 25 C).

Do not use this medicine if you notice particles or discolouration.

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

What Elfabrio contains

• The active substance is pegunigalsidase alfa. Each vial contains 20 mg pegunigalsidase alfa in 10 mL (2 mg/mL)
• The other ingredients are: tribasic dihydrate sodium citrate, citric acid, and sodium chloride (see section 2 Elfabrio contains sodium ).

What Elfabrio looks like and contents of the pack Clear and colourless solution in clear glass vial with a rubber stopper and sealed with aluminium flip off cap.

Pack sizes: 1, 5 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Chiesi Farmaceutici S.p.A. Via Palermo 26/A
43122 Parma
Italy

Manufacturer Chiesi Farmaceutici S.p.A. Via San Leonardo 43122 Parma Italy

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

Belgi /Belgique/Belgien Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 Lietuva Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073
Chiesi Bulgaria EOOD
.: +359 29201Luxembourg/Luxemburg Chiesi sa/nv T l/Tel: + 32 (0)2 788 42 esk republika Chiesi CZ s.r.o. Tel: + 420 261221Magyarorsz g Chiesi Hungary Kft. Tel.: + 36-1-429 1Danmark Chiesi Pharma AB Tlf: + 46 8 753 35 Malta Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Deutschland Chiesi GmbH Tel: + 49 40 89724-0

Nederland Chiesi Pharmaceuticals B.V. Tel: + 31 88 501 64 Eesti Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Norge Chiesi Pharma AB Tlf: + 46 8 753 35
Chiesi Hellas AEBE : + 30 210 6179 sterreich Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Espa a Chiesi Espa a, S.A.U. Tel: + 34 934948Polska Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1France Chiesi S.A.S.
T l: + 33 1 47688Portugal Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Hrvatska Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Rom nia Chiesi Romania S.R.L. Tel: + 40 212023Ireland Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Slovenija CHIESI SLOVENIJA, d.o.o. Tel: + 386-1-43 00 sland Chiesi Pharma AB S mi: +46 8 753 35 Slovensk republika Chiesi Slovakia s.r.o. Tel: + 421 259300Italia Chiesi Italia S.p.A. Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB Puh/Tel: +46 8 753 35
Chiesi Farmaceutici S.p.A. : + 39 0521 2Sverige Chiesi Pharma AB Tel: +46 8 753 35 Latvija Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2This leaflet was last revised in

Other sources of information

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