Elfabrio 2 mg/mL concentrate for solution for infusion

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Elfabrio 2 mg/mL concentrate for solution for infusion ${equilateral_black_triangle}$

Active Ingredient:

pegunigalsidase alfa

Company:

Chiesi Limited See contact details

ATC code:

A16AB20

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL) Risk Materials HCP Med Info

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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.

Last updated on emc: 11 Aug 2023

${equilateral_black_triangle}$ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 08829/0210.

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Elfabrio 2 mg/mL concentrate for solution for infusion

Package leaflet: Information for the user

Elfabrio 2 mg/mL

concentrate for solution for infusion

pegunigalsidase alfa

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. What Elfabrio is and what it is used for

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 α-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.

2. What you need to know before you are given Elfabrio

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.

3. How Elfabrio is given

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 advise 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.

4. Possible side effects

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:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland:

HPRA Pharmacovigilance

Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Elfabrio

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.

6. Contents of the pack and other information

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

United Kingdom (Northern Ireland) & Ireland:

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

Great Britain:

Chiesi Limited
333 Styal Road
Manchester
M22 5LG
United Kingdom

Manufacturer

Chiesi Farmaceutici S.p.A.
Via San Leonardo 96
43122 Parma
Italy

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

Ireland

Chiesi Farmaceutici S.p.A.

Tel: + 39 0521 2791

United Kingdom (Northern Ireland)

Chiesi Farmaceutici S.p.A.

Tel: + 39 0521 2791

Great Britain

Chiesi Ltd

Tel: + 44 (0)161 488 5555

This leaflet was last revised in May 2023

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

CP0080-1