Gamunex 100 mg/ml solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gamunex 100 mg/ml solution for infusion

normal human 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Gamunex is and what it is used for

2. What you need to know before using Gamunex

3. How to use Gamunex

4. Possible side effects

5. How to store Gamunex

6. Contents of the pack and other information

1. What Gamunex is and what it is used for

What Gamunex is

Gamunex contains human normal immunoglobulin (antibodies) as a highly purified protein derived from human plasma (a component of blood from donors). This medicine belongs to a group of medicines called intravenous immunoglobulins, which are used to treat diseases in which the body's defense system that fights illness is not functioning properly.

What Gamunex is used for

Treatment in adults, children, and adolescents (0–18 years of age) who lack sufficient antibodies (replacement therapy), such as:

• Patients with primary immunodeficiency syndrome (PIS), a congenital deficiency of antibodies.
• Patients with acquired immunodeficiency (AID) with severe or recurrent infections, ineffective antibiotic treatment, and demonstrated specific antibody deficiency or a serum IgG level <4 g/l.

Treatment in adults, children, and adolescents (0–18 years of age) who are susceptible and who have been exposed to measles or are at risk of future measles exposure, and in whom active immunization against measles is contraindicated or not recommended.

Treatment in adults, children, and adolescents (0–18 years of age) with certain autoimmune diseases (immunomodulation). These are classified into five groups:

• Primary immune thrombocytopenia, a condition in which the number of platelets in the bloodstream is drastically reduced. Platelets are an important part of the blood clotting process, and a low platelet count may cause unwanted bleeding and bruising. This medicine is also used in patients at high risk of bleeding or prior to surgery, to correct platelet count.
• Guillain-Barré syndrome, a condition in which the immune system attacks the nerves, preventing them from functioning properly.
• Kawasaki disease (in this case together with acetylsalicylic acid), a childhood illness in which blood vessels (arteries) in the body become enlarged.
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease causing weakness in the limbs, numbness, pain, and fatigue.
• Multifocal motor neuropathy (MMN), a rare disease causing slowly progressive weakness in the limbs without sensory loss.

Treatment in adults aged 18 years or older with:

• Severe acute exacerbations of myasthenia gravis. Myasthenia gravis is a disease causing muscle weakness; exacerbations primarily affect swallowing, speech, and breathing.

2. What you need to know before using Gamunex

Do not use Gamunex

• if you are allergic to normal human immunoglobulins or to any of the other components of this medicine (listed in section 6);
• if you have very low or absent levels of IgA-type immunoglobulins in your blood and have developed antibodies against IgA.

Warnings and precautions

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

Infusion reactions and hypersensitivity

Certain adverse reactions may be related to the infusion rate. Therefore, the recommended infusion rate must be followed (see "Information for healthcare professionals" at the end of this leaflet).

Certain adverse effects may occur more frequently:

• if the infusion rate is high;
• in patients with complete absence of gammaglobulins or low levels of gammaglobulin (agammaglobulinemia or hypogammaglobulinemia), with or without IgA deficiency;
• in patients receiving human immunoglobulin for the first time, or rarely, when switching from another immunoglobulin product or after a prolonged treatment-free interval.

Possible complications can often be avoided by ensuring that:

• you are not hypersensitive to human immunoglobulin by administering the initial Gamunex infusion slowly,
• you are closely monitored for symptoms during the infusion period. Especially if you are receiving human immunoglobulin for the first time, have switched from another immunoglobulin product, or have not received treatment for a long time, you should be monitored for possible adverse effects during the first infusion and for one hour afterward.

If adverse effects occur, the infusion rate should be reduced or the infusion stopped until symptoms resolve. If symptoms persist even after stopping the infusion, appropriate treatment should be initiated. In the case of an anaphylactic shock reaction (anaphylactic shock with severe drop in blood pressure), treatment with this medicine must be stopped immediately, and standard current medical treatment for shock should be started.

Patients with kidney problems and other risk factors

Cases of impaired renal function and acute kidney failure have been reported in association with intravenous administration of immunoglobulins. You are at particular risk if you have certain risk factors such as pre-existing kidney dysfunction (renal insufficiency), diabetes (diabetes mellitus), or reduced blood volume (hypovolemia). Other circumstances considered risk factors include being overweight, concomitant use of medications that are harmful to the kidneys, and/or being over 65 years of age. In any case, the following precautions should be taken:

• drink plenty of fluids to ensure adequate fluid intake before starting treatment;
• your doctor should monitor urine output and measure kidney function;
• avoid concomitant use of certain medications that increase urine production (loop diuretics).

The infusion rate in your case should be as slow as possible, and the immunoglobulin should be used at the lowest possible concentration. If kidney function impairment occurs, your doctor will consider discontinuing immunoglobulin treatment.

Hemolysis (abnormal destruction of red blood cells)

Hemolysis (increased risk of destruction of red blood cells) is frequently reported with immunoglobulins in both adults and children. If you receive high doses of IVIG on the same day or over several days and your blood group is A, B, or AB and/or you have an underlying inflammatory condition, you may be at increased risk of red blood cell destruction (hemolysis).

In post-marketing reports, high-dose IVIG indications in children, particularly Kawasaki disease, have been associated with a higher number of hemolytic reaction reports compared to other pediatric IVIG indications.

You should consult a doctor if you develop paleness (pale skin), lethargy (feeling of weakness), dark urine, shortness of breath, or palpitations (rapid heartbeat).

Isolated cases of renal failure associated with hemolysis with fatal outcomes have occurred.

Information on safety regarding infections

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

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

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

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. The measures may have limited effectiveness against non-enveloped viruses such as hepatitis A virus and/or parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly due to the presence of protective antibodies against these infections in the product.

This medicine contains less than 1 mmol of sodium (23 mg) per single dose (up to a maximum of 2 g/kg); i.e., it is essentially “sodium-free.”

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

Other medicines and Gamunex

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

You should avoid concomitant use of medications that increase water elimination from your body (loop diuretics) during treatment with Gamunex.

Effects on vaccines: Gamunex may reduce the effectiveness of certain types of vaccines (vaccines containing live attenuated viruses). For rubella, mumps, and varicella, a period of up to 3 months should elapse between administration of this medicine and administration of these vaccines. For measles, the interval may be up to 1 year.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Dizziness or other reactions may occur that could affect your ability to drive or use machines. If this happens, you should wait until these symptoms have resolved before driving or using machines.

3. How to use Gamunex

Your doctor will administer Gamunex into your veins (intravenous administration).

The dose you receive will depend on your condition and body weight, and will be determined by your doctor (see the section "Information intended for healthcare professionals" at the end of this leaflet).

At the beginning of the infusion, you will receive Gamunex at a slow rate. Then, depending on how you feel, your doctor may gradually increase the infusion rate.

If you interrupt treatment with Gamunex

If you interrupt treatment with this medicine, your clinical condition may worsen. Speak with your treating doctor if you wish to discontinue treatment with this medicine prematurely.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare and isolated cases of the following adverse effects have been reported with immunoglobulin preparations. Seek immediate medical attention if you experience any of the following during or after infusion:

• Sudden drop in blood pressure and, in isolated cases, anaphylactic shock (symptoms include rash, low blood pressure, rapid or irregular heartbeat, wheezing, cough, sneezing, and difficulty breathing, among others), even if you have not shown any allergic reaction during previous administrations.
• Cases of transient non-infectious meningitis (symptoms include headache, photophobia or light intolerance, neck stiffness).
• Cases of transient decrease in the number of red blood cells in the blood (hemolytic anemia/reversible hemolysis).
• Cases of transient skin reactions.
• Increase in serum creatinine levels (a test measuring kidney function) and/or acute renal failure (symptoms include lower back pain, fatigue, decreased urine output).
• Thromboembolic reactions such as, for example, myocardial infarction (chest tightness with sensation of rapid heartbeat), stroke (muscle weakness in the face, arm, or leg, difficulty speaking or understanding speech), pulmonary embolism (shortness of breath, chest pain, and fatigue), deep vein thrombosis (pain and swelling in a limb).
• Cases of transfusion-related acute lung injury (TRALI) causing hypoxia (lack of oxygen), difficulty breathing, rapid breathing, bluish discoloration of the skin or mucous membranes, fever, and low blood pressure.

The following adverse effects were observed in clinical trials with Gamunex:

The following adverse effects were frequent (may affect up to 1 in 10 infusions):

• Headache
• Fever

The following adverse effects were uncommon (may affect up to 1 in 100 infusions):

• Dizziness
• Urticaria (hives, redness, itching of the skin)
• Pruritus (itching)
• Rash
• Nausea
• Vomiting
• High blood pressure
• Sore throat
• Cough
• Nasal congestion
• Wheezing
• Joint pain
• Back pain
• Pseudoinfluenza syndrome
• Fatigue
• Chills
• Asthenia (weakness)
• Muscle pain

The following adverse effects were rare (may affect up to 1 in 1,000 infusions):

• Hemolytic anemia (destruction of red blood cells)
• Difficulty breathing
• Sinusitis
• Skin peeling
• Anxiety
• Decreased hemoglobin
• Indigestion
• Bruising
• Flushing
• Musculoskeletal stiffness
• Palmar erythema (redness of the palms of the hands)
• Aphonia (loss of voice)
• Decreased white blood cell count
• Dermatitis (skin inflammation) or contact dermatitis
• Abdominal pain
• Diarrhea
• Low blood pressure
• Neck pain
• Musculoskeletal pain
• Chest pain
• General malaise
• Injection site reaction
• Urethritis (pain or difficulty urinating)
• Viral upper respiratory tract infection (illness caused by an acute infection affecting the upper respiratory tract, including the nose, sinuses, and throat)
• Lymphocytosis (increase in the number of a specific type of white blood cells)
• Hypersensitivity (allergic reaction)
• Light sensitivity of the eyes
• Hypertensive crisis (acute increase in blood pressure)
• Hyperemia (increased blood flow)
• Hemoglobinuria (abnormally high levels in urine of the protein that carries oxygen in the blood)
• Increased blood pressure
• Presence of free hemoglobin (hemoglobin circulating outside red blood cells)
• Increased erythrocyte sedimentation rate (increased rate at which red blood cells settle in a test tube)

What to do if you experience adverse effects

If adverse effects occur, the infusion rate should be reduced or the infusion should be stopped until the signs of adverse effects have resolved. If symptoms persist even after stopping the infusion, appropriate treatment should be administered.

In the case of a severe hypersensitivity reaction with a drop in blood pressure and dyspnea progressing to severe generalized allergic reaction (anaphylactic shock), the use of this medicine must be immediately discontinued and appropriate measures must be initiated.

Reporting of adverse effects

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

5. Storage of Gamunex

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

Do not use this medicine after the expiry date stated on the carton and vial. The shelf life is 3 years.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep the vial in the outer packaging.

The medicine may be stored in its outer carton for a single period of up to 6 months at room temperature (maximum 25°C). In this case, the medicine's shelf life expires at the end of these 6 months, regardless of the original expiry date. The new expiry date must be recorded on the outer carton. However, the new expiry date must not be later than the printed expiry date. Re-refrigeration is not permitted.

After opening the individual container, the contents should be used immediately. Any unused portion must be discarded. Continued storage of the medicine is not allowed, even in the refrigerator, due to the possible risk of microbial contamination.

6. Contents of the pack and other information

Composition of Gamunex

The active substance is human normal immunoglobulin (IVIG). One ml of this medicinal product contains 100 mg of protein with an IgG content of at least 98% in water for injections.

A 10 ml vial contains: 1 g of human normal immunoglobulin
A 50 ml vial contains: 5 g of human normal immunoglobulin
A 100 ml vial contains: 10 g of human normal immunoglobulin
A 200 ml vial contains: 20 g of human normal immunoglobulin
A 400 ml vial contains: 40 g of human normal immunoglobulin

The percentage distribution of IgG subclasses is approximately 62.8% (IgG1), 29.7% (IgG2), 4.8% (IgG3) and 2.7% (IgG4).

The maximum IgA content is 66 micrograms/ml.

The other components are glycine and water for injections.

Presentation of the product and contents of the pack

Gamunex is an infusion solution. The solution is transparent to slightly opalescent and colourless to pale yellow.

Gamunex is available in pack sizes of 10 ml, 50 ml, 100 ml, 200 ml and 400 ml. The carton contains one glass vial with a stopper (chlorobutyl rubber), a label with a detachable part forming a handle, and a package leaflet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Grifols Deutschland GmbH
Colmarer Straße 22
60528 Frankfurt
Germany
Tel.: +49 69/660 593 100

Manufacturer:
Instituto Grifols, S.A.
Can Guasc, 2 – Parets del Vallès
08150 Barcelona
Spain

Local Representative:
Instituto Grifols, S.A.
Can Guasc, 2 – Parets del Vallès
08150 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany, Austria, Belgium, Cyprus, Ireland, Luxembourg, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland): Gamunex 10% 100mg/ml
Denmark, Slovakia, Spain, Finland, France, Hungary, Italy, Norway, Czech Republic, Sweden: Gamunex 100mg/ml
Greece: Gaminex 10% 100mg/ml

Date of the most recent revision of this leaflet: February 2026

Detailed 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/)

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This information is intended for healthcare professionals only:

Use only infusion solutions that are clear or slightly opalescent, colourless to pale yellow, and free from particles – do not shake. Before infusion, allow Gamunex to reach room temperature or body temperature (e.g. by using a water bath at a maximum temperature of 37°C).

The vials are supplied with a label featuring a detachable handle (Fig. 1). After inserting the infusion set (Fig. 2), invert the vial and fold back the label portion corresponding to the handle (Fig. 3). Press firmly with a finger to create a crease on each side where the handle joins the rest of the label (Fig. 4). Hang the vial on the infusion stand using the resulting handle (Fig. 5).

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

Dosage and method of administration

The dose and dosage regimen depend on the indication.

Dosage may need to be individualised for each patient based on clinical response. Weight-based dosing may require adjustment in patients with low body weight or obesity. The following dosage guidelines are provided for informational purposes.

The recommended dosage is summarised in the table below:

Route of administration

Intravenous route.

Normal human immunoglobulin should be administered intravenously at an initial rate of 0.6–1.2 ml/kg/h for 0.5 hours. In case of an adverse reaction, the infusion rate should be reduced or the infusion interrupted. If well tolerated, the infusion rate may be gradually increased up to a maximum of 4.8–8.4 ml/kg/h.

Paediatric population

The dosage in children and adolescents (0–18 years) is not different from that in adults, since the dosage for each indication is calculated according to body weight and adjusted according to the clinical outcome of the aforementioned diseases.

Gamunex must not be mixed with other infusion solutions or with other medicinal products. If dilution is required prior to infusion, a 50 mg/ml glucose solution may be used. Do not dilute with saline solutions.

Concomitant administration of Gamunex and heparin through a single-lumen administration device should be avoided.

The lines used for Gamunex infusion may be flushed with a 50 mg/ml glucose solution or with sodium chloride solution (9 mg/ml) and must not be flushed with heparin.

Heparinized lines through which Gamunex has been administered must be flushed with a 50 mg/ml glucose solution or with a sodium chloride solution (9 mg/ml) and must not be flushed with heparin.