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IQYMUNE 100 MG/ML SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN

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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 Barré 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).
If one of these effects occurs, alert a doctor who will, depending on the type and severity
of the reaction, immediately stop the treatment with IQYMUNE and/or start an
appropriate treatment.
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.
If one of these effects occurs, alert a doctor who will, depending on the type and
severity of the reaction, immediately stop the treatment with IQYMUNE and/or start an
appropriate treatment.

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 Français du Fractionnement et des Biotechnologies
3, Avenue des Tropiques – 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 Trévise
59000 Lille
FRANCE

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria: IQYMUNE 100 mg/mL Infusionslösung
Belgium: OPTIGLOBIN 100 mg/mL oplossing voor infusie, OPTIGLOBIN 100 mg/mL
solution pour perfusion, OPTIGLOBIN 100 mg/mL Infusionslösung
Czech Republic: IQYMUNE 100 mg/ml infuzní roztok
Denmark: IQYMUNE 100 mg/mL infusionsvæske, opløsning
Finland: OPTIGLOBIN 100 mg/mL infuusioneste, liuos
Germany: IQYMUNE 100 mg/mL Infusionslösung
Greece: IQYMUNE 100 mg/mL διάλυμα για έγχυση
Hungary: IQYMUNE 100 mg/mL oldatos infúzió
Italy: IQYMUNE 100 mg/mL soluzione per infusione
Luxembourg: OPTIGLOBIN 100 mg/mL solution pour perfusion
Slovakia: IQYMUNE 100 mg/ml infúzny roztok
Spain: IQYMUNE 100 mg/mL solución para perfusión
Sweden: IQYMUNE 100 mg/mL infusionsvätska, lösning
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.
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The following information is intended for healthcare professionals only:
Posology
The dosage recommendations are summarised in the following table:

Indication

Dose

Frequency of infusions

- 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.

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 Barré 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

Replacement therapy in primary
immunodeficiency

Immunomodulation:

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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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