Document: leaflet MAH BRAND_PL 28315-0008 change

• leaflet MAH BRAND_PL 17469-0007
• leaflet MAH BRAND_PL 28315-0008

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Package leaflet: Information for the user IQYMUNE 100 mg/mL solution for infusion

Human normal immunoglobulin (IVIg)

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.

What is in this leaflet

1.    What IQYMUNE is and what it is used for

2.    What you need to know before you use 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 medecine contains antibodies. It belongs to the class of medicines called immunoglobulins. These medicines contain human antibodies, produced by our immune system.

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 five groups:

1.    Patients with inborn lack of antibody production (primary immunodeficiency syndromes).

2.    Patients with a cancer of the blood (chronic lymphocytic leukaemia) that leads to a lack of antibody production and frequent infections when preventative antibiotics have failed.

3.    Patients with cancer of the bone marrow (multiple myeloma) and lack of antibody production with frequent infections who have failed to respond to a vaccine against certain bacteria (pneumococci).

4.    Patients with low antibody production following transplantation of bone marrow cells from another person.

5.    Patients with AIDS from birth and frequent bacterial infections.

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

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

3.    Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease).

2. WHAT YOU NEED TO KNOW BEFORE YOU USE IQYMUNE Do not use IQYMUNE

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

For example, 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.

White blood cells

A decrease in the number of certain white blood cells (neutropenia) is common. Usually, it occurs within hours or days after the infusion and resolves spontaneously within 7 to 14 days.

Before using this medicine, you should tell the doctor when you know you have:

•    a low number of white blood cells

•    a condition or you take a medicine which could decrease the number of white blood cells.

Dosing adjustment

The doctor will adjust the dosage regimen of IQYMUNE and the infusion rate depending on your disease but also depending on your body weight, your state of health (hydration, kidney function, other concomitant diseases, potential side effects) and other medicines which you are taking. Please inform your doctor of all medicines taken and diseases which you have or have had.

Monitoring during administration of IQYMUNE

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.

To avoid any risk of reaction IQYMUNE will firstly be administered to you slowly and you will need to remain under the supervision of a doctor or a nurse:

•    throughout all the infusion and for at least one hour after the infusion 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 previously received this medicine or if the last infusion was administered a long time ago,

•    throughout all the infusion and for at least 20 minutes after the infusion if you have recently received this medicine.

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. In this situation you must call your doctor or nurse immediately.

Depending on your allergic reaction the doctor may decide to reduce the rate of your infusion or to stop it. He/she may also start treatment for the allergy 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. Special patient groups

This medicine may very rarely cause or worsen a kidney disease (acute kidney failure) or a disease of the heart and blood vessels (myocardial infarction, cerebrovascular accident, 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.

Because of this your doctor will monitor your kidneys and/or your heart and your blood vessels:

•    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 (diabetes),

•    if you have an insufficient volume of blood in your body (hypovolemia),

•    if your weight is too high (obesity),

•    if you are over 65 years old,

•    if you already have a disease of the heart or blood vessels,

•    if you have high blood pressure,

•    if you are at risk of being immobilised for a long period of time,

•    if you are suffering from a disease causing an increase in blood viscosity.

If you have any of the above predisposing factors, the doctor will adjust the dose and infusion rate at which IQYMUNE is administered.

Information on safety with respect to infections

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

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

•    careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,

•    the testing of each donation and pools of plasma for signs of virus/infections,

•    the inclusion of steps in the processing of the 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 passing on infection cannot be totally excluded. This also applies to any unknown or emerging 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 antibodies against these infections, which are contained in the product, are protective.

It is strongly recommended that every time you are given a dose of IQYMUNE the name and batch number of the product are recorded in order to maintain a record of the batches used.

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.

Effects on blood tests

Some antibodies contained in IQYMUNE may invalidate the results of certain blood 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).

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, this medicine can cause side effects, although not everybody gets them. Risk of allergic reactions

Allergic reactions can occur uncommonly. In some cases, these reactions have progressed to a serious allergic reaction.

The warning signs of allergic reactions are:

•    swelling of the face or throat,

•    feeling of burning and tingling at the infusion site,

•    chills,

•    redness,

•    itching and rash,

•    low blood pressure,

•    extreme tiredness (lethargy),

•    feeling sick (nausea), vomiting,

•    restlessness,

•    fast heart rate,

•    tightness of the chest,

•    pins and needles,

•    wheezing (asthma-like).

Blood clots

Formation of blood clots may occur in the blood circulation. It may result in:

•    heart attack, the warning signs are sudden chest pain or shortness of breath.

•    stroke, the warning signs are sudden onset of muscle weakness, loss of sensation and/or balance, decreased alertness or difficulty in speaking.

•    a serious condition called pulmonary embolism, the warning signs are chest pain, difficulty in breathing or coughing up blood.

•    clot in a vein (venous thrombosis), the warning signs are redness, feel warmth, pain, tenderness, or have a swelling of one or both legs.

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

•    decreased number of white blood cells (neutropenia) . See also "white blood cells” in section 2.

•    headache,

•    high blood pressure (hypertension)

•    fever, chills, tiredness (fatigue).

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

•    decreased number of white blood cells (leukopenia, lymphopenia, monocytopenia),

•    allergic reaction (anaphylactoid reaction),

•    inflammation of the layers lining the brain (meningitis aseptic), dizziness, vertigo,

•    blood circulatory disorder in extremity (peripheral vascular disorder),

•    nausea, vomiting, belly pain,

•    skin rash, sweats, pain of skin,

•    back pain, joint pain, pain in extremity, bone pain, chest pain,

•    malaise, flu-like illness, feeling cold, pain at the infusion site, swellings (oedema peripheral),

•    infusion related reaction,

•    blood tests revealing changes to kidney functions (creatinine renal clearance decreased, blood creatinine increased),

•    body temperature increase.

The following adverse reactions were not observed with IQYMUNE but were reported with other immunoglobulin preparations:

•    sudden fall in blood pressure,

•    skin reaction

•    decreased number of red blood cells (haemolytic reactions/haemolytic anemia).

•    kidney failure

•    blood clots (see also the section "blood clots")

•    serious allergic reaction even when the patient has shown no allergic reaction to previous administration (see also the section "allergic reactions").

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

This medicine 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 to pale brown.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratoire Frangais du Fractionnement et des Biotechnologies 3, Avenue des T ropiques - ZA de Courtaboeuf - 91940 LES ULIS - FRANCE Tel: + 33(0) 1 69 82 70 10 Fax: + 33(0) 1 69 82 19 03

Manufacturer:

LFB BIOMEDICAMENTS 59 rue de Trevise 59000 Lille FRANCE

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

Austria: IQYMUNE 100 mg/mL Infusionslosung

Belgium: OPTIGLOBIN 100 mg/mL oplossing voor infusie, OPTIGLOBIN 100 mg/mL

solution pour perfusion, OPTIGLOBIN 100 mg/mL Infusionslosung

Czech Republic: IQYMUNE 100 mg/ml infuznf roztok

Denmark: IQYMUNE 100 mg/mL infusionsv^ske, oplosning

Finland: OPTIGLOBIN 100 mg/mL infuusioneste, liuos

Germany: IQYMUNE 100 mg/mL Infusionslosung

Greece: IQYMUNE 100 mg/mL 5iaAuga Yia £YXuan

Hungary: IQYMUNE 100 mg/mL oldatos infuzio

Italy: IQYMUNE 100 mg/mL soluzione per infusione

Luxembourg: OPTIGLOBIN 100 mg/mL solution pour perfusion

Slovakia: IQYMUNE 100 mg/ml infuzny roztok

Spain: IQYMUNE 100 mg/mL solucion para perfusion

Sweden: IQYMUNE 100 mg/mL infusionsvatska, losning

The Netherlands: OPTIGLOBIN 100 mg/mL oplossing voor infusie

United Kingdom: IQYMUNE 100 mg/mL solution for infusion

This leaflet was last revised in August 2015.

Posology

The dosage recommendations are summarised in the following table:

Indication	Dose	Frequency of infusions
Replacement therapy in primary immunodeficiency	-    starting dose: 0.4 - 0.8 g/kg -    thereafter: 0.2 - 0.8 g/kg	every 3 - 4 weeks to obtain IgG trough level of at least 5 - 6 g/L
Replacement therapy in secondary immunodeficiency	0.2 - 0.4 g/kg	every 3 - 4 weeks to obtain IgG trough level of at least 5 - 6 g/L
Congenital AIDS	0.2 - 0.4 g/kg	every 3 - 4 weeks
Hypogammaglobulinaemia (< 4 g/L) in patients after allogeneic haematopoietic stem cell transplantation	0.2 - 0.4 g/kg	every 3 - 4 weeks to obtain IgG trough level above 5 g/L.
Immunomodulation:
Primary immune thrombocytopenia	0.8 - 1 g/kg or 0.4 g/kg/d	on day 1, possibly repeated once within 3 days for 2 - 5 days
Guillain Barre syndrome	0.4 g /kg/d	for 5 days
Kawasaki disease	1.6 - 2 g/kg or	in divided doses over 2 - 5 days in association with acetylsalicylic acid
	2 g/kg	in one dose in association with acetylsalicylic acid

Method of administration

For intravenous use.

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

Special precautions

•    Some side effects may be related to the infusion rate. The recommended infusion rate must be observed. If adverse effects occur the administration rate must be reduced or the infusion stopped. IQYMUNE must be administered 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.

Instructions for handling and disposal

The solution must be inspected visually before administration. The solution must be clear or slightly opalescent, colourless to pale brown. Do not use a solution which is cloudy or contains a deposit.

Any unused product or waste material should be disposed of in accordance with local requirements.