IQYMUNE 100 mg/mL, solution for infusion

• 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.

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

This medicine contains human antibodies, produced by our immune system. It belongs to the class of medicines called immunoglobulins.

• 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.

This medicine is used for:

The treatment of patients who do not have sufficient antibodies (replacement therapy). There are two groups:

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

2. Patients with an acquired deficiency of antibodies (secondary immunodeficiency) due to specific diseases and/or treatments and experiencing severe or recurrent infections

The treatment of patients with certain inflammatory disorders (immunomodulation). There are five 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). IQYMUNE should be administered in combination with acetylsalicylic acid.
4. Patients who suffer from an inflammation of peripheral nerves that causes muscle weakness and/or numbness mainly in the arms and legs (chronic inflammatory demyelinating polyradiculoneuropathy, CIDP).
5. Patients who suffer from a rare condition characterized by slowly progressive and asymmetrical muscle weakness of the arms and legs without sensory loss (multifocal motor neuropathy, MMN).

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

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.

Talk to your doctor, pharmacist or nurse before using IQYMUNE.

Certain adverse reactions may occur more frequently:

• in case of high rate of infusion.
• when you receive IQYMUNE for the first time or it is a long time since your last infusion. You will be watched carefully until an hour after the infusion to detect potential side effects.

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.

Allergic reactions are rare. 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. Tell your doctor or healthcare professional immediately if you notice such reactions during or after the infusion of IQYMUNE.

Depending on your adverse reaction the doctor may decide to reduce the rate of your infusion or to stop it. He/she may also start treatment for the adverse event 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.

Patients with pre-existing risk factors

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

Please inform your doctor of all medicines taken and diseases which you have or have had. Your doctor will take special care for you:

• 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 in your blood (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 (arterial hypertension),
• if you are at risk of being immobilised for a long period of time,
• if you are suffering from a disease which causes an increase of your blood thickening (hyperviscous blood).

White blood cells

A transient decrease in the number of certain white blood cells (leukopenia/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, or
• you take a medicine which could decrease the number of white blood cells.

Aseptic meningitis syndrome

Aseptic meningitis syndrome (reversible and non-infectious) has been reported to occur with immunoglobulin treatment such as IQYMUNE. The syndrome usually begins within several hours to 2 days following the treatment and may occur with the following symptoms: fever, headache, stiff neck, nausea, vomiting.

If you experience such symptoms, please check with your health care provider for a thorough neurological examination, to rule out other causes of meningitis.

Haemolytic anaemia/Haemolysis

Haemolytic anaemia (transient decrease of red blood cells, due to their destruction) can develop subsequently to immunoglobulin therapy such as IQYMUNE, particularly if you are of blood group A, B or AB. Reversible haemolytic anaemia may be characterized by the following symptoms: pallor, fatigue, weakness, yellowish skin or eyes, dark urine. If you receive immunoglobulins such as IQYMUNE, you should be monitored for clinical signs and symptoms of haemolysis.

Transfusion related acute lung injury (TRALI)

In patients receiving immunoglobulin such as IQYMUNE, there have been rare cases of Transfusion Related Acute Lung Injury (TRALI). This disease is characterized by decrease of oxygen level in the body (hypoxemia), difficulties in breathing (dyspnoea), increase of the respiratory rate (tachypnoea), blueing skin (cyanosis), fever and decrease of the blood pressure (hypotension). Symptoms of TRALI typically appear during the infusion of immunoglobulin or within 6 hours following the infusion, often within 1 to 2 hours. Therefore, if you notice any such reactions during IQYMUNE infusion, tell your doctor immediately. He/she will decide whether the infusion rate should be decreased or whether the infusion should be stopped.

Information on virus safety

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.

There are no specific or additional warnings or precautions applicable for children and adolescents.

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.

Loop diuretics

Please avoid the concomitant use of loop diuretics together with IQYMUNE.

Some antibodies contained in IQYMUNE may invalidate the results of certain blood tests (serological 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.

• 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.

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.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially “sodium-free”.

The same indications, dose and frequency of infusion as for adults apply for children and adolescents (aged 0 to 18 years-old).

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.

Depending on the type and severity of the reaction, your doctor will immediately stop the treatment with IQYMUNE and/or start an appropriate treatment:

• Allergic reaction: rash, itching, hives, shortness of breath, low blood pressure, dizziness, wheezing (asthma-like), fast heart rate
• Swelling of the face, mouth or throat leading to difficulty in breathing
• Heart attack: Chest pain or shortness of breath
• Stroke: sudden onset of muscle weakness, loss of sensation and/or balance, decreased vigilance or difficulty in speaking
• Blood clot in the lungs: chest pain, difficulty in breathing or coughing up blood
• Thrombosis/Blood clot: pain and swelling of limbs, redness.
• Transfusion Related Acute Lung Injury (TRALI): difficulties in breathing, shortness of breath, marbled skin, fever and low blood pressure.
• Aseptic meningitis: severe headache, fever, stiff neck, nausea, vomiting, light sensitivity.
• Haemolytic anaemia: pallor, fatigue, weakness, yellowish skin or eyes, reddish urine
• Severe kidney disorder: dark colored urine during or after your infusion, difficulty urinating and/or a decrease in urine output

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

• decreased number of one type of white blood cells (neutropenia). See also “white blood cells” in section 2.
• headache,
• high blood pressure (hypertension)
• fever, tiredness (fatigue), chills.

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

• decreased number of other types of white blood cells (leukopenia, lymphopenia, monocytopenia),
• temporary decrease in the number of red blood cell (anaemia),
• allergic reaction (anaphylactic reaction),
• dizziness (including vertigo sensation), migraine,
• upset stomach (nausea), vomiting, abdominal pain, oral pain,
• skin rash, itching (pruritus), excessive sweating (hyperhidrosis), redness of the skin (erythema),
• back pain, pain in joints and bones (arthralgia), pain in extremity, muscule pain (myalgia),
• administration site reaction, malaise, flu-like illness, swellings (oedema peripheral),
• blood tests revealing changes to kidney functions (creatinine renal clearance decreased),

The following adverse reactions are rare (up to 1 in 1000 infusions):

• transitient ischaemic attack,
• inflammation of the membranes that surround the brain and spinal cord (reversible aseptic meningitis),
• sensations like numbness (paraesthesia),
• inflammation of the eyelids (blepharitis allergic), eye irritation,
• skin turning blue (cyanosis peripheral), hot flush,
• dry throat,
• loose stools (diarrhoea),
• cramps (muscle spasms),
• discomfort,
• blood tests revealing changes to kidney functions (blood creatinine increased), body temperature increased, fibrin D dimer increased,
• infusion related reaction,

The following side effects have been reported spontaneously with IQYMUNE:

• anaphylactic shock,
• excessive breakdown of red blood cells (haemolytic anaemia),
• thromboembolic reactions including stroke, heart attack (myocardial infarction), clot in the blood vessel in the lungs (pulmonary embolism), blood clot in a deep vein (deep vein thrombosis),
• acute kidney injury.

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.

• 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.

IQYMUNE 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 or pale brown or pale yellow.

Not all pack sizes may be marketed.

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