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IQYMUNE 100 MG/ML SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN

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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.

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.

IQYMUNE

CONFIDENTIAL

0.8 – 1 g/kg
or
0.4 g/kg/d

on day 1, possibly repeated once within 3 days

Guillain Barré
syndrome

0.4 g /kg/d

for 5 days

Kawasaki disease

1.6 – 2 g/kg
or
2 g/kg

in divided doses over 2 – 5 days in association
with acetylsalicylic acid
in one dose in association with acetylsalicylic acid

Solution for infusion
Human normal immunoglobulin (IVIg)

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.

This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting any
side effects you may get. See the end of section 4 for 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, your 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.

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.

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.

for 2 – 5 days

1. What IQYMUNE is and what is it used for
What IQYMUNE is
This medicine 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
(autoimmune disease). This medicine provides these antibodies to you.

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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).

Package leaflet: information for the user
4. Patients with low antibody production following transplantation of bone
marrow cells from another person.
5. P atients with AIDS from birth and frequent bacterial infections.
The treatment of patients with certain inflammatory disorders
(immunomodulation). There are three groups:
1. P atients 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. P atients with a disease that is associated with multiple inflammations of the
nerves in the whole body (Guillain Barré syndrome).
3. P atients 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
Adecrease 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.

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100 mg/mL

Special precautions
• Some side effects may be related to the infusion rate. The recommended

Immunomodulation:
Primary immune
thrombocytopenia

AR/16C051/2.0 - September 2016
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Mock-up Package leaflet

The following information is intended for health professionals only:

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

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 phamacist 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.

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.

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.

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.

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 used 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.
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,

2

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.

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.

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.

The following adverse reactions are uncommon (up to 1 in 100 infusions):
decreased number of white blood cells (leukopenia, lymphopenia,
•
monocytopenia),
• inflammation of the layers lining the brain (meningitis aseptic), dizziness,
vertigo,
• belly pain,
• sweats, pain of skin,
• back pain, joint pain, pain in extremity, bone pain, chest pain,
•m
 alaise, 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.

Marketing Authorisation Holder:
Laboratoire Français du Fractionnement et des Biotechnologies
3, Avenue des Tropiques – ZA de Courtabœuf - 91940 LES ULIS – FRANCE
Tel: + 33(0) 1 69 82 70 10
Fax: + 33(0) 1 69 82 19 03

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”).

4. Possible side effects

5. How to store IQYMUNE

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.

Marketing authorisation Holder and Manufacturer

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 07/2016.

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• low blood pressure,
• extreme tiredness (lethargy),
• feeling sick (nausea), vomiting,
• restlessness,
• fast heart rate,
• tightness of the chest,
• pins and needles,
• wheezing (asthma-like).

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CONFIDENTIAL

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.

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.

AR/16C051/2.0 - September 2016
1.3.2
Mock-up Package leaflet

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.

Expand Transcript

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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