IQYMUNE 100 mg/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

IQYMUNE100mg/mL solution for infusion

Human normal immunoglobulin (IgIV)

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on 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, 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.

Contents of the pack and other information

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

1. What is Iqymune and what is it used for

What is Iqymune

This medicine contains antibodies. It belongs to a group of medicines called immunoglobulins. These medicines contain human antibodies, produced by our immune system.

How Iqymune works

• The human antibodies in this medicine allow the body to fight infections or balance the immune system.
• If you do not have enough antibodies, the antibodies provided by this medicine can replace the ones you are missing. The antibodies in Iqymune have been isolated from human plasma, so they work exactly like your own antibodies.
• This type of medicine can also be used in cases of immune system imbalance and when you need more antibodies in certain inflammatory disorders (autoimmune diseases). This medicine provides you with these 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 an acquired lack of antibodies (secondary immunodeficiency) due to specific diseases and/or treatments and who have severe or recurrent infections.

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

1. Patients who do not have enough platelets in the blood (Primary Immune Thrombocytopenia, PIT) and are at high risk of bleeding or are about to undergo surgery.
2. Patients with a disease associated with multiple inflammatory disorders of the nerves throughout the body (Guillain-Barré syndrome).
3. Patients with a disease that causes multiple inflammatory disorders in various organs of the body (Kawasaki disease). Iqymune should be administered in combination with acetylsalicylic acid.
4. Patients with inflammation of the peripheral nerves that causes muscle weakness or numbness, mainly in the arms and legs (Chronic Inflammatory Demyelinating Polyneuropathy, CIDP).
5. Patients who suffer from a rare disease characterized by asymmetric muscle weakness of slow progression in 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 any of the other ingredients of this medicine (listed in section 6).

For example, if you have a lack of immunoglobulin A, you may have antibodies against immunoglobulin A in your blood. This medicine contains minimal amounts of immunoglobulin A, so you may have an allergic reaction.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Iqymune.

Leukocytes

It is common for the number of certain leukocytes (leukopenia/neutropenia) to decrease temporarily. This usually occurs in the hours or days following infusion and resolves spontaneously within 7 to 14 days.

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

• a low number of leukocytes, or
• are taking a medicine that may decrease the number of leukocytes.

Aseptic meningitis syndrome

Aseptic meningitis syndrome (reversible and non-infectious) has been reported in association with treatments with immunoglobulins like Iqymune. The syndrome usually appears within a few hours to 2 days after treatment and may manifest with the following symptoms: fever, headache, neck stiffness, nausea, vomiting.

Aseptic meningitis may occur more frequently in association with high-dose immunoglobulin treatment (2 g/kg) like Iqymune.

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

Discontinuation of treatment has led to the resolution of aseptic meningitis within several days without sequelae.

Hemolytic anemia/Hemolysis

After treatment with immunoglobulins like Iqymune, hemolytic anemia (temporary decrease in red blood cells due to their destruction) may occur, especially if your blood group is A, B, or AB.

Reversible hemolytic anemia may manifest with the following symptoms: pallor, fatigue, weakness, jaundice, dark urine. If you receive immunoglobulins like 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 like Iqymune. This disease is characterized by a decrease in oxygen levels in the body (hypoxemia), difficulty breathing (dyspnea), increased respiratory rate (tachypnea), blue discoloration of the skin (cyanosis), fever, and decreased blood pressure (hypotension). TRALI symptoms usually appear during or within 6 hours after immunoglobulin infusion. Therefore, if you experience any of these reactions during Iqymune infusion, inform your doctor immediately so that they can decrease the infusion rate or stop the infusion.

Dose adjustment

Your doctor will adjust the administration schedule and infusion rate of Iqymune based on your disease, body weight, physical condition (hydration, kidney function, other concurrent diseases, potential side effects), and other medications you are taking. Inform your doctor of all medications you are taking and any diseases you have or have had.

Monitoring during Iqymune administration

To avoid the risk of reactions, your doctor will check the infusion rate and adjust it as needed. During infusion, your doctor will implement medical monitoring measures to detect signs of allergy or any other reaction.

To avoid the risk of reaction, Iqymune will be administered at a low rate for the first 30 minutes, and you will need to remain under medical supervision:

• during the entire infusion and for at least 1 hour after completion if your doctor decides to use a high infusion rate, if you have a low amount of antibodies in your blood, if you have never received this medicine before, or if the last infusion was a long time ago.
• during the entire infusion and for at least 20 minutes after completion if you have recently received this medicine.

If you experience an allergic reaction, initial symptoms will be dizziness, swelling of the face/legs, difficulty breathing, skin rash, and/or itching. If this occurs, call your doctor or nurse immediately.

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

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

Special patient groups

Very rarely, this medicine may cause or worsen kidney disease (acute kidney injury) or heart and blood vessel disease (myocardial infarction, stroke, pulmonary embolism, or deep vein thrombosis). Patients who already have a disease or have certain risk factors should be cautious when using this medicine.

For this reason, your doctor will monitor your kidneys and/or heart and blood vessels:

• if you already have kidney disease (renal failure),
• if you are taking certain medications that may be harmful to the kidneys,
• if you have high blood sugar (diabetes),
• if you have low blood volume (hypovolemia),
• if you are overweight (obesity),
• if you are over 65 years old,
• if you already have heart or blood vessel disease,
• if you have high blood pressure (hypertension),
• if you are at risk of being immobile for a long time,
• if you have a disease that causes blood thickening (hyperviscosity).

If you have any of the above factors, your doctor will adjust the dose and infusion rate of Iqymune, solution for infusion.

Safety information related to infections

This medicine is made from human blood plasma (the liquid part of the blood).

When medicines are made from blood or plasma, certain measures are taken to avoid the transmission of infections to patients. Some of these measures are:

• careful selection of plasma donors to ensure that those at risk of carrying infections are excluded,
• testing of each donation and plasma pools for signs of viruses/infections,
• inclusion of steps in the processing of blood or plasma that can inactivate or remove viruses.

Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting an 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 for 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 in the product have a protective function.

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

Using Iqymune with other medicines

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 like Iqymune may reduce the effectiveness of vaccines against measles, rubella, mumps, and/or varicella for 3 months. It is recommended to wait for a period of 3 months between the last administration of immunoglobulins and the administration of these vaccines. In the case of the measles vaccine, it may be necessary to wait 1 year after the last administration of immunoglobulins. Before your doctor vaccinates you, inform them that you are receiving treatment with Iqymune.

Diuretics

The concomitant use of certain medications that may be harmful to the kidneys (loop diuretics) should be avoided.

Effects on blood tests

Some of the antibodies in Iqymune may invalidate the results of certain blood tests (serological tests). If your doctor or the person taking your blood sample does not know that you have received Iqymune, inform them before they perform the test.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• No studies on reproduction have been conducted with Iqymune in animals, 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 in Iqymune are excreted in breast milk and may contribute to protecting the child from certain infections.

Driving and using machines

Patients may experience reactions (e.g., dizziness or nausea) during treatment with Iqymune that may affect their ability to drive and use machines. 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, so it is essentially "sodium-free".

3. How to use Iqymune

This medicine is for intravenous administration (infusion into a vein).

It will be administered by your doctor or nurse.

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

At the start 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 use more Iqymune than you should

This medicine is usually administered under medical supervision, so it is unlikely that an overdose will occur. If, despite this, you receive more Iqymune than you should, the blood may become too thick (hyperviscosity). This may occur especially if you are a patient at risk, for example, if you are an elderly patient or have heart or kidney problems. Make sure to drink enough fluids to avoid dehydration and inform your doctor if you have any medical problems.

4. Possible Adverse Effects

Like all medicines, Iqymune can cause adverse effects, although not all people suffer from them.

Risk of Allergic Reactions

Allergic reactions may occur infrequently. In some cases, these reactions have worsened to become a severe allergic reaction.

The warning signs of allergic reactions are:

• swelling of the face or throat
• sensation of itching and tingling at the infusion site,
• chills,
• erythema,
• pruritus and rash,
• hypotension,
• extreme fatigue (lethargy),
• general malaise (nausea), vomiting,
• restlessness,
• rapid heart rate,
• chest tightness,
• muscle aches,
• wheezing (similar to asthma).

Blood Clots

Blood clots may develop in the circulatory system. These can cause:

• a myocardial infarction, whose warning signs are sudden chest pain or difficulty breathing.
• a stroke, whose warning signs are sudden loss of muscle strength, loss of sensitivity and/or balance, decreased level of consciousness or difficulty speaking.
• a pulmonary embolism, whose warning signs are chest pain, difficulty breathing or coughing up blood.
• a clot in a vein (venous thrombosis), whose warning signs are erythema, sensation of heat, pain, pain on palpation or swelling in one or both legs.

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

• decrease in the number of a type of white blood cell (neutropenia). See also the "White Blood Cells" section of section 2.
• headache,
• fever, fatigue.

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

• decrease in the number of other types of white blood cells (leukopenia, lymphopenia, monocytopenia),
• dizziness,
• high blood pressure (hypertension),
• nausea, vomiting, abdominal pain,
• skin rash, itching (pruritus),
• back pain, joint pain, pain in a limb,
• muscle pain (myalgia)
• general malaise, flu-like illness, swelling (peripheral edema),
• chills
• changes in kidney function (decreased renal clearance of creatinine) observed in blood tests,
• increased body temperature,
• increased blood pressure

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

• allergic reaction (anaphylactoid reaction),
• inflammation of the layers covering the brain (reversible aseptic meningitis),
• vertigo,
• disorder of blood circulation in a limb (peripheral vascular disorder),
• mouth pain,
• skin pain,
• excessive sweating (hyperhidrosis),
• bone pain,
• musculoskeletal chest pain,
• cramps (muscle spasms),
• sensation of cold,
• pain at the infusion site,
• infusion-related reaction,
• changes in kidney function (elevated creatinine in blood) observed in blood tests,
• dry throat.

The following adverse reactions have not been observed with Iqymune, but have been reported with other immunoglobulin preparations:

• sudden drop in blood pressure,
• temporary decrease in the number of red blood cells (hemolytic anemia/reversible hemolysis).
• kidney failure
• blood clots (see also the "Blood Clots" section).
• severe allergic reaction even if the patient has not shown any allergic reaction to a previous administration (see also the "Allergic Reactions" section).
• rare cases of acute lung injury related to transfusion (TRALI), which is a serious complication that can occur during immunoglobulin infusion or within 6 hours after administration

Reporting of Adverse Effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the outer packaging and the vial label after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that the solution is cloudy or contains 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 the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Iqymune

• The active ingredient of 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 ingredients are: glycine, polysorbate 80, and water for injectable preparations.

Appearance of the Product and Package Contents

Iqymune is a solution for infusion in 20 mL, 50 mL, 100 mL, or 200 mL vials.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

LFB BIOTERAPIAS HISPANIA, S.L.

C/ Diego de León 47

28006 Madrid

(Spain)

This medicine 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 δι?λυμα για ?γχυση

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 the last revision of this leaflet: May 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Dosage

The recommended doses are summarized in the following table:

Method of Administration

Only by intravenous route.

During the first 30 minutes, normal human immunoglobulin should be administered intravenously at a rate of 0.5 mL/kg/h. If it is well tolerated, the administration rate can be gradually increased to a maximum of 6 mL/kg/h.

Special Precautions

• Some serious side effects may be related to the infusion rate. The recommended infusion rate should be respected. If adverse effects occur, the administration rate should be reduced or the infusion stopped. Iqymune should be administered using a 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, a record be kept of the name of the medicine and the batch number administered in order to maintain a link between the patient and the batch of the product.

Incompatibilities

In the absence of compatibility studies, this product should not be mixed with other medicines.

Handling and Disposal Instructions

The solution should be visually inspected before administration. The solution should be transparent or slightly opalescent, between colorless and pale brown. Do not use cloudy or sediment-containing solutions.

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