Prospecto: information for the user

IQYMUNE100mg/mL infusion solution

Human normal immunoglobulin (IgIV)

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

1. What is Iqymune and what it is used for

2. What you need to know before starting to use Iqymune

3. How to use Iqymune

4. Possible adverse effects

5. Storage of Iqymune

6. Contents of the package and additional information

What is Iqymune

This medication contains antibodies. It belongs to a class of medications called immunoglobulins. These medications contain human antibodies, produced by our immune system.

How Iqymune works

• The human antibodies contained in this medication allow the body to fight infections or balance the immune system.
• If you do not have enough antibodies, the antibodies provided in this medication may replace the ones you lack. The antibodies in Iqymune have been isolated from human plasma, so they act exactly like your own antibodies.
• This type of medication may also be used in cases of immune system imbalance and if you need more antibodies in certain inflammatory disorders (autoimmune diseases). This medication provides those antibodies.

What is Iqymune used for

This medication 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 deficiency in antibody production (primary immunodeficiency syndromes).

2.Patients with an acquired deficiency of antibodies (secondary immunodeficiency) due to specific diseases and/or treatments and who present 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, PTI) and with a high risk of bleeding or who are about to undergo a surgical procedure soon.

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 must be administered in combination with acetylsalicylic acid

4. Patients with peripheral nerve inflammation 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 progressive muscle weakness of the arms and legs without sensory loss (Multifocal Motor Neuropathy [MMN])

No use Iqymune

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Iqymune.

Leucocytes

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

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

• a low number of leucocytes, or
• take a medication that may decrease the number of leucocytes.

Asymptomatic meningitis syndrome

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

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

If you experience these symptoms, consult the healthcare professional who is following you for a detailed neurological evaluation to exclude other causes of meningitis.

The interruption of treatment has caused the remission of asymptomatic meningitis within several days without sequelae.

Hemolytic anemia/Hemolysis

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

Reversible hemolysis may manifest with the following symptoms: pallor, fatigue, weakness, jaundice, dark urine. If you receive immunoglobulins like Iqymune, you should be monitored for any clinical signs or symptoms of hemolysis.

Acute lung injury related to transfusion (TRALI)

Rare cases of acute lung injury related to transfusion (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). The symptoms of TRALI usually appear during infusion or within 6 hours after administration.

Therefore, if you experience any of these reactions during Iqymune infusion, inform your doctor immediately to decrease the infusion rate or stop the infusion.

Dose adjustment

Your doctor will adjust the administration schedule of Iqymune and the infusion rate based not only on your disease, but also on your body weight, physical condition (hydration, kidney function, other simultaneous diseases, possible side effects), and other medications you are taking. Inform your doctor of all medications you are taking and of 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 necessary for you. During infusion, your doctor will implement monitoring measures to detect signs of allergy or any other reaction.

To avoid the risk of reaction, Iqymune will be administered to you at a slow rate during the first 30 minutes and you will need to remain under the supervision of a doctor or nurse:

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

If you experience an allergic reaction, the initial symptoms will be dizziness, facial swelling/leg swelling, 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 for advice.

Special patient groups

In rare cases, this medication may cause or worsen kidney disease (acute kidney injury) or heart and blood vessel disease (myocardial infarction, stroke (including cerebral hemorrhage), pulmonary embolism, or deep vein thrombosis). Patients who already suffer from a disease or have certain risk factors should be cautious when using this medication.

Therefore, your doctor will monitor your kidneys and/or your heart and blood vessels:

• if you already suffer from kidney disease (renal failure),
• if you are taking certain medications that may be harmful to your kidneys,
• if you have a high amount of sugar in your blood (diabetes),
• if you have a low volume of blood in your body (hypovolemia),
• if you have excessive weight (obesity),
• if you are over 65 years old,
• if you already suffer from heart or blood vessel disease,
• if you have high blood pressure (hypertension),
• if you are at risk of prolonged immobility,
• if you suffer from a disease that causes blood thickening (hyperviscosity syndrome).

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

Information on safety related to infections

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

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

• careful selection of plasma donors to ensure that those with a risk of being carriers of infections are excluded,
• checking each donation and plasma mixtures for signs of viruses/infections,
• including phases in the processing of blood or plasma that can inactivate or eliminate viruses.

Despite these measures, when administering medications derived from blood or human plasma, it cannot be ruled out that the infection may be transmitted. This also applies to emerging or unknown viruses and other types of infections.

The measures taken are considered effective for viruses such as 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 have a protective function.

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

Use of Iqymune with other medications

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

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 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 of the asa

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

Effects on blood tests

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

Pregnancy, lactation, and fertility

• If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.
• No studies have been conducted on reproduction with Iqymune in animals, and the experience in pregnant women is limited. Although no adverse 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 contribute to protecting the baby from certain infections.

Driving and operating machines

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

Iqymune contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

This medication is for intravenous administration (infusion in a vein).

You will be administered this medication by your doctor or nurse.

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

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

Use in children and adolescents

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

If you use more Iqymune than you should

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

Like all medicines, Iqymune can cause side effects, although not everyone will experience them.

Risk of allergic reactions

Allergic reactions can 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
• Itching and tingling sensation at the infusion site,
• Chills,
• Erythema,
• Pruritus and rash,
• Hypotension,
• Extreme fatigue (lethargy),
• General malaise (nausea), vomiting,
• Anxiety,
• Fast heart rate,
• Pressure in the chest,
• Cramping,
• Wheezing (similar to asthma-like).

Blood clots

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

• Myocardial infarction, whose warning signs aresharp chest pain or difficult breathing.
• Cerebrovascular accident, whose warning signs aresudden onset of muscle weakness, loss of sensation and/or balance, decreased level of consciousness or difficulty speaking.
• Pulmonary embolism, whose warning signs arechest pain, difficulty breathing or coughing up blood.
• Thrombosis in a vein, whose warning signs areerythema, warmth, pain, tenderness or swelling in one or both legs.

The following adverse reactions are frequent (up to1of10infusions):

• Decrease in the number of a type of white blood cell (neutropenia). See also the section «White blood cells» in section2.
• Headache,
• Fever, fatigue (fatigue).

The following adverse reactions are infrequent (up to1of100infusions):

• Decrease in the number of other types of white blood cells (leucopenia, lymphopenia, monocytopenia),
• Dizziness,
• High blood pressure (hypertension),
• Nausea, vomiting, abdominal pain,
• Skin rash, itching (pruritus),
• Back pain, joint pain, pain in an extremity,
• Muscle pain (myalgia)
• General malaise, flu-like illness, peripheral edema,
• Chills
• Changes in kidney function (decreased creatinine clearance) 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),
• Dizziness,
• Peripheral vascular disorder,
• Oral pain,
• Pain in the skin,
• Excessive sweating (hyperhidrosis),
• Bone pain,
• Chest pain musculoskeletal,
• Cramping (muscle spasms),
• Sensation of cold,
• Pain at the infusion site,
• Reaction associated with infusion,
• 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 (reversible hemolytic anemia/hemolysis).
• Renal failure
• Blood clots (see also the section «Blood clots»).
• Severe allergic reaction even if the patient has not shown any allergic reaction to a previous administration (see also the section «Allergic reactions»).
• Rare cases of acute lung injury related to transfusion (TRALI), which is a serious complication that can occur during infusion of immunoglobulin or within 6 hours after administration

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the outer packaging and the vial label after CAD. The expiration date is the last day of the month indicated.

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

Do not store at a temperature above 25°C. Do not freeze.

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

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment..

Composition of Iqymune

• The active principle of Iqymune ishuman normal immunoglobulin.
• 1mL of Iqymune contains 100mg of human protein, of which at least 95% is immunoglobulinG.
• The other components are: glycine, polisorbate80 and water for injectable preparations.

Appearance of the product and contents of the package

Iqymune is a perfusion solution in vials of 20mL, 50mL, 100mL or 200mL.

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

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratoire Français du Fractionnement et des Biotechnologies

Tour W, 102 Terrasse Boieldieu 19èmeÉtage, 92800 Puteaux, FRANCE

Tel.: + 33(0) 1 69 82 70 10

Responsible for manufacturing:

LFB BIOMEDICAMENTS

59rue de Trévise

59000Lille

FRANCE

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

LFB BIOTERAPIAS HISPANIA,S.L.

C/ Diego de León 47

28006 Madrid

(Spain)

This medication is authorized in the member states of the European Economic Area with the following names:

Germany: IQYMUNE 100 mg/mL Infusionslösung

Austria: IQYMUNE 100 mg/mL Infusionslösung

Belgium: IQYMUNE100 mg/mL oplossing voor infusie,IQYMUNE100 mg/mL solution pour perfusion,IQYMUNE100 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: IQYMUNE100 mg/mL solution pour perfusion, IQYMUNE100 mg/mL Infusionslösung

Netherlands: IQYMUNE100 mg/mL oplossing voor infusie

Czech Republic: IQYMUNE 100 mg/ml infuzní roztok

Sweden: IQYMUNE 100 mg/mL infusionsvätska, lösning

Last review date of this leaflet: May 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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