Iqymune 100 mg / ml solution for infusion – patient leaflet, side effects, dosage

1. WHAT IQYMUNE IS AND WHAT IT IS USED FOR

What IQYMUNE is

This medicine contains human antibodies, produced by our immune system. It belongs to the class of medicines called immunoglobulins.

How IQYMUNE works

•The human antibodies contained in this medicine allow your body to fight infections or to balance your immune system.

• If you do not have enough antibodies, the antibodies provided in this medicine can replace the missing antibodies. As IQYMUNE antibodies have been isolated from human plasma they act exactly as if they were your own antibodies.
• This type of medicine can also be used if your immune system is out of balance and if you need additional antibodies in some inflammatory disorders (auto-immune disease). This medicine provides these antibodies to you. What IQYMUNE is used for

This medicine is used for :

The treatment of patients who do not have sufficient antibodies (replacement therapy). There are two groups:

1. 1. Patients born with lack of antibody production (primary immunodeficiency syndromes).
2. 2. Patients with an acquired deficiency of antibodies (secondary immunodeficiency) due to specific diseases and/or treatments and experiencing severe or recurrent infections

The treatment of patients with certain inflammatory disorders (immunomodulation). There are five groups:

1. 1. Patients who do not have enough blood platelets (primary immune thrombocytopenia, ITP), and who are at high risk of bleeding or will have surgery in the near future.
2. 2.

   Patients with a disease that is associated with multiple inflammations of the nerves in the whole body (Guillain Barré syndrome).

   1. 3. Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease). IQYMUNE should be administered in combination with acetylsalicylic acid.
   2. 4. Patients who suffer from an inflammation of peripheral nerves that causes muscle weakness and/or numbness mainly in the arms and legs (chronic inflammatory demyelinating polyradiculoneuropathy, CIDP).
   3. 5. Patients who suffer from a rare condition characterized by slowly progressive and asymmetrical muscle weakness of the arms and legs without sensory loss (multifocal motor neuropathy, MMN).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE IQYMUNE

Do not use IQYMUNE

If you are allergic to immunoglobulins or to any of the other ingredients of this medicine (listed in section 6).

If you have an immunoglobulin A deficiency, you may have antibodies against immunoglobulin A in your blood. Since this medicine contains trace amounts of immunoglobulin A, you might get an allergic reaction.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using IQYMUNE. Certain adverse reactions may occur more frequently:

• in case of high rate of infusion.
• when you receive IQYMUNE for the first time or it is a long time since your last infusion. You will be watched carefully until an hour after the infusion to detect potential side effects.

In order to avoid a risk of a reaction the doctor will check the infusion rate and adjust it so it is suitable for you. During the infusion your doctor will put in place medical monitoring in order to detect any signs of allergy or any other reactions. Allergic reactions are rare. If an allergy develops you will recognize the initial signs by dizziness, swelling of the face/legs, shortness of breath, spots on the skin and/or itching. Tell your doctor or healthcare professional immediately if you notice such reactions during or after the infusion of IQYMUNE. Depending on your adverse reaction the doctor may decide to reduce the rate of your infusion or to stop it. He/she may also start treatment for the adverse event if he/she considers this to be necessary.

If you have any doubt, please do not hesitate to ask your doctor or your nurse for advice.

Patients with pre-existing risk factors

This medicine may very rarely cause or worsen a kidney disease (acute kidney failure), a disease of the heart and/or a disease of the blood vessels (myocardial infarction, cerebrovascular accident (including stroke), pulmonary embolism or deep venous thrombosis). Patients who are already suffering from a disease or who have certain risk factors must take care when using this medicine. Please inform your doctor of all medicines taken and diseases which you have or have had. Your doctor will take special care for you:

• if you already have a kidney disease (renal failure),
• if you are taking certain medicines which may be dangerous for your kidneys,
• if you have a high level of sugar in your blood (diabetes),
• if you have an insufficient volume of blood in your body (hypovolemia), 00000-0000000-000000/0.0

Read all of this leaflet carefully before you start using this medicine be-cause 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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Solution for infusion

Human normal immunoglobulin (IVIg) Package leaflet: Information for the user

gradually be increased to a maximum of 6 mL/kg/hr.

Clinical data obtained from a limited number of patients with PID and

indicate that adult and children’s patients may tolerate an infusion rate

8 mL/kg/hr.

Special precautions

• Certain adverse reactions may be related to the rate of infusion. The recom

infusion rate must be closely followed. If adverse effects occur the admin

rate must be reduced or the infusion stopped. IQYMUNE should be adm

at a minimal infusion rate and dose in patients at risk of acute renal failure or thromboembolic reaction.

• It is strongly recommended that every time IQYMUNE is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Incompatibilities

In the absence of compatibility studies this product must not be mixed with other medicinal products, nor with any other IVIg product.

Instructions for handling and disposal

The solution must be inspected visually before administration. The solution should be clear or slightly opalescent and colourless or pale brown or pale yellow. Solutions that are cloudy or have deposits should not be used. Any unused product or waste material should be disposed of in accordance with local requirements.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: IQYMUNE 100 mg/mL Infusionslösung

Belgium : IQYMUNE 100 mg/mL oplossing voor infusie The Netherlands: IQYMUNE100 mg/mL oplossing voor infusie Czech Republic: IQYMUNE 100 mg/ml infuzní roztok

Denmark: IQYMUNE 100 mg/mL infusionsvæske, opløsning Finland: IQYMUNE 100 mg/mL infuusioneste, liuos

Germany: IQYMUNE 100 mg/mL Infusionslösung

Greece: IQYMUNE 100 mg/mL διάλυμα για έγχυση

Hungary: IQYMUNE 100 mg/mL oldatos infúzió

Italy: IQYMUNE 100 mg/mL soluzione per infusione

Luxembourg: IQYMUNE 100 mg/mL solution pour perfusion Spain: IQYMUNE 100 mg/mL solución para perfusión Sweden: IQYMUNE 100 mg/mL infusionsvätska, lösning United Kingdom: IQYMUNE 100 mg/mL solution for infusion This leaflet was last revised in 04/2026.

The following information is intended for healthcare professionals only:

Posology

The dosage recommendations are summarised in the following table:

Method of administration

For intravenous use only.

Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 mL/kg/hr for 30 minutes. If well tolerated, the rate of administration may

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the name and batch number of the product are recorded in order to maintain a record of the batches used.

Children and adolescents

There are no specific or additional warnings or precautions applicable for children and adolescents.

Other medicines and IQYMUNE

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

Effects on vaccines

The use of immunoglobulins such as IQYMUNE may reduce the effectiveness of vaccines against measles, rubella, mumps and/or varicella for 3 months. It is recommended that a period of 3 months elapse between the last administration of immunoglobulins and administration of these vaccines. It may be necessary to wait for 1 year after the last administration of immunoglobulins for the measles vaccine. Before you are vaccinated by your doctor, please tell him/her that you are being treated with IQYMUNE.

Loop diuretics

Please avoid the concomitant use of loop diuretics together with IQYMUNE. Effects on blood tests

Some antibodies contained in IQYMUNE may invalidate the results of certain blood tests (serological tests). If your doctor or the person who is taking your blood sample does not know that you have received IQYMUNE, please tell him/ her before having this blood test.

Pregnancy, 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 taking this medicine.
• No reproduction studies have been performed with IQYMUNE in animals and experience in pregnant women is limited. Although no harmful effect has been reported on the foetus, IQYMUNE should not be administered to pregnant women unless the need for treatment has been clearly established.
• The antibodies contained in IQYMUNE are excreted in human milk and may contribute to protecting your baby from certain infections.

Driving and using machines

Patients may experience reactions (for example dizziness or nausea) during the treatment with IQYMUNE which might affect the ability to drive and use machines. If this happens, you should not drive or use machines until these effects have disappeared. IQYMUNE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially “sodium-free”.

3. How to use IQYMUNE

This medicine is intended for intravenous administration (infusion into a vein). It is given to you by your doctor or nurse.

Dose and frequency of the infusion will vary depending on your condition and your body weight.

At the beginning of your infusion you will receive IQYMUNE at a slow rate. Dependent on how comfortable you are, your doctor may then gradually increase the infusion rate.

Use in children and adolescents

The same indications, dose and frequency of infusion as for adults apply for children and adolescents (aged 0 to 18 years-old).

If you use more IQYMUNE than you should

Overdose is very unlikely to occur because this medicine is usually administered under medical supervision. If, in spite of this, you receive more IQYMUNE than you should, your blood may become too thick (hyperviscous). This may happen particularly if you are a patient at risk, for example if you are elderly or if you have problems with your

heart or kidneys. Be sure that you take adequate fluids so you are not dehydrated and notify your physician if you are known to have medical problems.

4. POSSIBLE SIDE EFFECTS

Like all medicines, IQYMUNE can cause side effects, although not everybody gets them.

Contact your doctor as soon as possible if you suffer from any of the side effects listed below. Depending on the type and severity of the reaction, your doctor will immediately stop the treatment with IQYMUNE and/or start an appropriate treatment:

• Allergic reaction: rash, itching, hives, shortness of breath, low blood pressure, dizziness, wheezing (asthma-like), fast heart rate
• Swelling of the face, mouth or throat leading to difficulty in breathing
• Heart attack: Chest pain or shortness of breath
• Stroke: sudden onset of muscle weakness, loss of sensation and/or balance, decreased vigilance or difficulty in speaking
• Blood clot in the lungs: chest pain, difficulty in breathing or coughing up blood
• Thrombosis/Blood clot: pain and swelling of limbs, redness.
• Transfusion Related Acute Lung Injury (TRALI): difficulties in breathing, shortness of breath, marbled skin, fever and low blood pressure.
• Aseptic meningitis: severe headache, fever, stiff neck, nausea, vomiting, light sensitivity.
• Haemolytic anaemia: pallor, fatigue, weakness, yellowish skin or eyes, reddish urine
• Severe kidney disorder: dark colored urine during or after your infusion, difficulty urinating and/or a decrease in urine output

The following side effects have been reported during clinical trials with IQYMUNE (in decreasing frequency):

The following adverse reactions are common (up to 1 in 10 infusions):

• decreased number of one type of white blood cells (neutropenia). See also “white blood cells” in section 2.
• headache,
• high blood pressure (hypertension)
• fever, tiredness (fatigue), chills.

The following adverse reactions are uncommon (up to 1 in 100 infusions):

• decreased number of other types of white blood cells (leukopenia, lymphopenia, monocytopenia),
• temporary decrease in the number of red blood cell (anaemia),
• allergic reaction (anaphylactic reaction),
• dizziness (including vertigo sensation), migraine,
• upset stomach (nausea), vomiting, abdominal pain, oral pain,
• skin rash, itching (pruritus), excessive sweating (hyperhidrosis), redness of the skin (erythema),
• back pain, pain in joints and bones (arthralgia), pain in extremity, muscule pain (myalgia),
• administration site reaction, malaise, flu-like illness, swellings (oedema peripheral),
• blood tests revealing changes to kidney functions (creatinine renal clearance decreased),

The following adverse reactions are rare (up to 1 in 1000 infusions):

• transitient ischaemic attack,
• inflammation of the membranes that surround the brain and spinal cord (reversible aseptic meningitis),
• sensations like numbness (paraesthesia),
• inflammation of the eyelids (blepharitis allergic), eye irritation,
• skin turning blue (cyanosis peripheral), hot flush,

• dry throat,

  • loose stools (diarrhoea),
  • cramps (muscle spasms),
  • discomfort,
  • blood tests revealing changes to kidney functions (blood creatinine increased), body temperature increased, fibrin D dimer increased,
  • infusion related reaction,

The following side effects have been reported spontaneously with IQYMUNE:

• anaphylactic shock,
• excessive breakdown of red blood cells (haemolytic anaemia),
• thromboembolic reactions including stroke, heart attack (myocardial infarction), clot in the blood vessel in the lungs (pulmonary embolism), blood clot in a deep vein (deep vein thrombosis),
• redness and peeling of the skin,
• acute kidney injury.

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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE IQYMUNE

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 outer carton and the vial label after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the solution is cloudy or has particles floating within the solution.

Do not store above 25°C. Do not freeze.

Keep the vial in the outer carton in order to protect from light. 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 IQYMUNE contains

• The active substance of IQYMUNE is human normal immunoglobulin.
• 1 mL of IQYMUNE contains 100 mg of human protein of which at least 95% is immunoglobulin G.
• The other ingredients are: glycine, polysorbate 80 and water for injections.

What IQYMUNE looks like and contents of the pack

IQYMUNE is a solution for infusion in vials of 20 mL, 50 mL, 100 mL or 200 mL. The solution is clear or slightly opalescent, colourless or pale brown or pale yellow. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratoire Français du Fractionnement et des Biotechnologies Tour W - 102 Terrasse Boieldieu 19ème Étage - 92800 Puteaux - FRANCE Tel: + 33(0) 1 69 82 70 10

Manufacturer:

LFB BIOMEDICAMENTS

59 rue de Trévise

59000 Lille

FRANCE 3 2

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