IQYMUNE 100 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

IQYMUNE 100 mg/mL solution for infusion

Human normal immunoglobulin (IgIV)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What IQYMUNE is and what it is used for

What IQYMUNE is

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

How IQYMUNE works

• The human antibodies in this medicine help the body fight infections or restore balance to the immune system.
• If you do not have enough antibodies, the antibodies provided by this medicine can replace those you are missing. The antibodies in IQYMUNE have been isolated from human plasma, so they function exactly as if they were your own antibodies.
• This type of medicine can also be used in cases of immune system imbalance and when additional antibodies are needed for certain inflammatory disorders (autoimmune diseases). This medicine provides those antibodies.

What IQYMUNE is used for

This medicine is used for the following:

Treatment of patients who do not have enough antibodies (replacement therapy). There are two groups:

1. Patients with a congenital lack of antibody production (primary immunodeficiency syndromes).
2. Patients with acquired antibody deficiency (secondary immunodeficiency) due to specific diseases and/or treatments, who experience severe or recurrent infections.

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

1. Patients with low platelet counts in the blood (primary immune thrombocytopenia, ITP) who are at high risk of bleeding or who are about to undergo surgery.
2. Patients with a disease involving multiple inflammatory disorders of the nerves throughout the body (Guillain-Barré syndrome).
3. Patients with a disease that causes widespread inflammatory disorders in various body organs (Kawasaki disease). IQYMUNE must be administered in combination with acetylsalicylic acid.
4. Patients with inflammation of the peripheral nerves causing muscle weakness or numbness, primarily in the arms and legs (chronic inflammatory demyelinating polyneuropathy [CIDP]).
5. Patients suffering from a rare disease characterized by slowly progressive, asymmetric muscle weakness in the arms and legs without sensory loss (multifocal motor neuropathy [MMN]).

2. What you need to know before using IQYMUNE

Do not use IQYMUNE

• If you are allergic to immunoglobulins or to any of the other components of this medicine (listed in section 6).
• If you have immunoglobulin A (IgA) deficiency, you may have antibodies against IgA in your blood. This medicine contains minimal amounts of IgA, so you may experience an allergic reaction.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use IQYMUNE.

Certain adverse reactions may occur more frequently:

• If the infusion rate is high.
• When you are receiving IQYMUNE for the first time or if a long time has passed since your last infusion. You will be closely monitored for up to one hour after the infusion to detect possible adverse reactions.

To minimize the risk of reactions, your doctor will check and adjust the infusion rate as appropriate for you. During the infusion, your doctor will implement medical monitoring measures to detect signs of allergy or other reactions.

Allergic reactions are uncommon. If you experience an allergic reaction, initial symptoms may include dizziness, facial or leg swelling, difficulty breathing, skin rash and/or itching. Inform your doctor or healthcare professional immediately if you notice any of these reactions during or after IQYMUNE infusion.

Depending on the adverse reaction, your doctor may decide to reduce the infusion rate or stop the infusion. They may also start treatment for the adverse event if necessary.

If you have any doubts, consult your doctor or nurse.

Patients with pre-existing risk factors

Very rarely, this medicine may cause or worsen kidney disease (acute renal failure), heart disease, or blood vessel disorders (myocardial infarction, stroke [including cerebral stroke]), pulmonary embolism, or deep vein thrombosis. Patients who already have a disease or certain risk factors should exercise caution when using this medicine.

Inform your doctor about all medications you are taking and any medical conditions you have or have had. Your doctor will pay special attention if:

• You already have kidney disease (renal failure),
• You are taking certain medications that may be harmful to the kidneys,
• You have high blood sugar levels (diabetes),
• You have insufficient blood volume in the body (hypovolemia),
• You are overweight (obesity),
• You are over 65 years old,
• You already have heart or blood vessel disease,
• You have high blood pressure (hypertension),
• You are at risk of prolonged immobility,
• You have a condition causing thickening of the blood (blood hyperviscosity).

Leukocytes

A temporary decrease in certain white blood cells (leukopenia/neutropenia) is common. This usually occurs within hours or days after infusion and resolves spontaneously within 7 to 14 days.

Before using this medicine, inform your doctor if you know that you have:

• A low white blood cell count, or
• Are taking a medication that could reduce your white blood cell count.

Aseptic meningitis syndrome

Aseptic meningitis syndrome (reversible and non-infectious) has been reported with immunoglobulin treatments such as IQYMUNE. The syndrome typically occurs within a few hours up to 2 days after treatment and may present with symptoms such as fever, headache, neck stiffness, nausea, and vomiting.

If you experience these symptoms, consult your healthcare provider for a detailed neurological evaluation to rule out other causes of meningitis.

Hemolytic anemia/Hemolysis

Hemolytic anemia (a temporary decrease in red blood cells due to their destruction) may occur after treatment with immunoglobulins such as IQYMUNE, especially if your blood group is A, B, or AB.

Reversible hemolytic anemia may present with symptoms such as pallor, fatigue, weakness, jaundice (yellowing of the skin or eyes), or dark urine. If you receive immunoglobulins such as IQYMUNE, you should be monitored for any signs or symptoms of hemolysis.

Transfusion-related acute lung injury (TRALI)

Rare cases of transfusion-related acute lung injury (TRALI) have been reported in patients treated with immunoglobulins such as IQYMUNE. This condition is characterized by low oxygen levels in the body (hypoxemia), difficulty breathing (dyspnea), increased respiratory rate (tachypnea), bluish discoloration of the skin (cyanosis), fever, and low blood pressure (hypotension). TRALI symptoms usually occur during or within 6 hours after immunoglobulin infusion, typically between 1 and 2 hours after administration. Therefore, if you experience any of these reactions during IQYMUNE infusion, inform your doctor immediately so they can reduce the infusion rate or stop the infusion.

Viral safety information

When medicines are made from human blood or plasma, certain measures are taken to prevent transmission of infections to patients. These measures include:

• Careful selection of plasma donors to ensure that those at risk of carrying infections are excluded,
• Testing of each plasma donation and plasma pools for signs of viruses/infections,
• Inclusion of manufacturing steps that can inactivate or remove viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting infection cannot be completely ruled out. This also applies to emerging or unknown viruses and other types of infections.

The measures taken are considered effective against viruses such as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus, and parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections contained in the product may have a protective effect.

It is strongly recommended that each time a dose of IQYMUNE is administered, the name and batch number of the medicine be recorded to maintain a record of the batches used.

Children and adolescents

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

Use of IQYMUNE with other medicines

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

Effects on vaccines

The use of immunoglobulins such as IQYMUNE may reduce the effectiveness of measles, rubella, mumps, and/or varicella vaccines for up to 3 months. It is recommended to wait at least 3 months between the last administration of immunoglobulins and the administration of these vaccines. For the measles vaccine, it may be necessary to wait up to 1 year after the last immunoglobulin administration. Before vaccination, inform your doctor that you are receiving treatment with IQYMUNE.

Loop diuretics

Concomitant use of loop diuretics with IQYMUNE should be avoided.

Effects on blood tests

Some of the antibodies contained in IQYMUNE may interfere with the results of certain blood tests (serological tests). If your doctor or the person drawing your blood sample is unaware that you have received IQYMUNE, inform them before the test is performed.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
• Reproduction studies with IQYMUNE in animals have not been conducted, and experience in pregnant women is limited. Although no harmful effects on the fetus have been reported, 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 breast milk and may help protect the infant against certain infections.

Driving and using machines

Patients may experience reactions (e.g., dizziness or nausea) during treatment with IQYMUNE that could affect their ability to drive or operate machinery. If this occurs, do not drive or use machines until these effects have resolved.

IQYMUNE contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free.”

3. How to use IQYMUNE

This medicine is for intravenous administration (intravenous infusion).

It will be administered to you by your doctor or nurse.

The dose and frequency of infusion will vary depending on your condition and body weight.

At the beginning of the infusion, you will receive IQYMUNE at a low rate. Your doctor may gradually increase the infusion rate depending on how well you tolerate it.

Use in children and adolescents

In children and adolescents (0 to 18 years of age), the same indications, doses, and infusion frequencies are used as in adults.

If you are given more IQYMUNE than you should

This medicine is normally administered under medical supervision, so overdose is very unlikely. However, if you do receive more IQYMUNE than you should, your blood may become too thick (hyperviscosity). This is more likely to occur if you are at risk, for example, if you are elderly or have heart or kidney problems. Make sure you drink enough fluids to avoid dehydration and inform your doctor if you have any medical problems.

4. Possible adverse effects

Like all medicines, IQYMUNE may produce adverse effects, although not everyone experiences them.

Contact your doctor as soon as possible if you experience any of the following adverse reactions listed below. Depending on the type and severity of the reaction, your doctor will immediately stop treatment with IQYMUNE or initiate appropriate treatment:

• Allergic reaction: skin rash, itching, hives, difficulty breathing, low blood pressure, dizziness, wheezing (asthma-like), rapid heart rate,
• Swelling of the face, mouth, or throat that makes breathing difficult,
• Myocardial infarction: chest pain or difficulty breathing,
• Stroke: sudden onset of muscle weakness, loss of sensation or balance, decreased alertness, or difficulty speaking,
• Blood clot in the lungs: chest pain, difficulty breathing, or coughing up blood,
• Thrombosis/blood clot: pain and swelling in limbs, redness,
• Transfusion-related acute lung injury (TRALI): difficulty breathing, shortness of breath, marbled skin appearance, fever, and hypotension,
• Aseptic meningitis: severe headache, fever, neck stiffness, nausea, vomiting, sensitivity to light,
• Hemolytic anemia: paleness, fatigue, weakness, yellowing of the skin or eyes, reddish urine,
• Severe kidney disorder: dark-colored urine during or after infusion, difficulty urinating, or reduced urine output.

During clinical trials with Iqymune, the following adverse reactions have been reported (listed from most to least frequent):

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

• Decrease in the number of a type of white blood cells (neutropenia). See also the "Leucocytes" section in section 2.
• Headache,
• High blood pressure (hypertension),
• Fever, tiredness (fatigue), chills.

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

• Decrease in the number of other types of white blood cells (leukopenia, lymphopenia, monocytopenia),
• Temporary decrease in white blood cell count (anemia),
• Allergic reaction (anaphylactic reaction),
• Dizziness (also with sensation of vertigo), migraine,
• Stomach discomfort (nausea), vomiting, abdominal pain, mouth pain,
• Skin rash, itching (pruritus), excessive sweating (hyperhidrosis), skin redness (erythema),
• Back pain, joint and bone pain (arthralgia), limb pain,
• Muscle pain (myalgia),
• Reaction at the site of administration,
• General malaise, flu-like illness, swelling (peripheral edema),
• Changes in kidney function (decreased creatinine clearance) observed in blood tests.

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

• Transient ischemic attack,
• Inflammation of the membranes surrounding the brain and spinal cord (reversible aseptic meningitis),
• Sensations of numbness (paresthesia),
• Eyelid inflammation (allergic blepharitis), eye irritation,
• Bluish skin (peripheral cyanosis), hot flush,
• Sore throat,
• Soft stools (diarrhea),
• Cramps (muscle spasms),
• Malaise,
• Changes in kidney function (elevated blood creatinine) observed in blood tests, increased body temperature, increased fibrin D-dimer,
• Infusion-related reaction.

The following adverse reactions have been reported spontaneously with Iqymune:

• Anaphylactic shock,
• Excessive breakdown of red blood cells (hemolytic anemia),
• Thromboembolic reactions, including stroke, myocardial infarction, blood clot in a pulmonary vessel (pulmonary embolism), blood clot in a deep vein (deep vein thrombosis),
• Acute kidney injury.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of IQYMUNE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the vial label after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the solution is cloudy or contains floating particles.

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

Keep the vial in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of IQYMUNE

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

Appearance of the product and contents of the container

IQYMUNE is an infusion solution supplied in vials of 20 mL, 50 mL, 100 mL, or 200 mL.

The solution is transparent or slightly opalescent, colorless or pale yellow or brown.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

LFB BIOMEDICAMENTS
59 rue de Trévise
59000 Lille
FRANCE

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

LFB BIOTERAPIAS HISPANIA, S.L.
C/ Diego de León 47
28006 Madrid
(Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: IQYMUNE 100 mg/mL Infusionslösung
Austria: IQYMUNE 100 mg/mL Infusionslösung
Belgium: IQYMUNE 100 mg/mL oplossing voor infusie, IQYMUNE 100 mg/mL solution pour perfusion, IQYMUNE 100 mg/mL Infusionslösung
Denmark: IQYMUNE 100 mg/mL infusionsvæske, opløsning
Spain: IQYMUNE 100 mg/mL solución para perfusión
Finland: IQYMUNE 100 mg/mL infuusioneste, liuos
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, IQYMUNE 100 mg/mL Infusionslösung
Netherlands: IQYMUNE 100 mg/mL oplossing voor infusie
Czech Republic: IQYMUNE 100 mg/ml infuzní roztok
Sweden: IQYMUNE 100 mg/mL infusionsvätska, lösning

Date of most recent review of this summary: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only:

Dosage

The recommended doses are summarized in the following table:

Route of administration

Intravenous use only.

For the first 30 minutes, normal human immunoglobulin should be administered intravenously at a rate of 0.5 mL/kg/h. If well tolerated, the infusion rate may be gradually increased up to a maximum of 6 mL/kg/h.

Clinical data from a limited number of patients with CIDP and ITP also indicate that adult and pediatric patients may tolerate an infusion rate of up to 8 mL/kg/hour.

Special precautions

• Certain adverse reactions may be related to the infusion rate. The recommended infusion rate must be carefully observed. If adverse effects occur, the infusion rate should be reduced or the infusion stopped. Iqymune should be administered using the minimum infusion rate and dose in patients at risk of acute renal failure or thromboembolic reaction.
• It is strongly recommended that each time IQYMUNE is administered to a patient, the name of the medicinal product and the batch number administered should be recorded, in order to maintain traceability between the patient and the product batch.

Incompatibilities

In the absence of compatibility studies, this product must not be mixed with other medicinal products or with other IVIG products.

Instructions for handling and disposal

The solution should be inspected visually before administration. The solution should be transparent or slightly opalescent, colorless, or pale yellow to brown. Turbid solutions or those containing particulate matter must not be used.

Disposal of unused medicinal product and of all materials that have come into contact with it should be carried out in accordance with local regulations.