Patient Leaflet Updated 02-Oct-2018 | LFB Biopharmaceuticals Limited
IQYMUNE 100 mg/mL, solution for infusion
Package leaflet: information for the user
IQYMUNE 100 mg/mL
Solution for infusion
Human normal immunoglobulin (IVIg)
▼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.
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 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
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 four 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).
4. Patients who suffer from a rare condition characterized by slow progressive asymmetrical weakness of limbs without sensory loss (multifocal motor neuropathy, MMN).
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:
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:
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 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:
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
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 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.
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:
Development of blood clots may occur in the blood circulation. It may result in:
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):
The following adverse reactions are rare (up to 1 in 1000 infusions):
The following adverse reactions were not observed with IQYMUNE but were reported with other immunoglobulin preparations:
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
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:
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 05/2018.
PO Box 63587, London, N6 9BR
+44 (0)77 67 755396
+44 (0)7767 755 396