Elfabrio 2 mg/mL concentrate for solution for infusion

• 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.

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

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

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.

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.

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

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.

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.

This medicine contains 46 mg sodium (main component of cooking/table salt) in each 10 mL vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult. This medicine contains 11.5 mg sodium (main component of cooking/table salt) in each 2.5 mL vial. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.

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.

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

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:

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

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

• The active substance is pegunigalsidase alfa. Each vial contains 20 mg pegunigalsidase alfa in 10 mL or 5 mg pegunigalsidase alfa in 2.5 mL (2 mg/mL)
• The other ingredients are: tribasic dihydrate sodium citrate, citric acid, and sodium chloride (see section 2 “Elfabrio contains sodium”).

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.